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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • J u l y 2 0 1 3 • Volume 39 Number 7

Study Questions Current Hypothermia Quality Measure

esearch showing that more than 7% of thoracic surgery patients experience postoperative hypothermia despite active warming is raising questions about the appropriateness of current criteria for the hypothermia quality measure. The study, led by David Bronheim, MD, associate professor in the Department of Anesthesiology at Icahn School of Medicine at Mount Sinai, in New York City, was a retrospective analysis of medical records from 316 thoracic surgery patients treated at

Online Camera Hookup Links Hospitals to War-Zone Clinicians Study demonstrates feasibility of remote airway management

hysicians performing emergency endoscopic procedures on the battlefield may soon have another tool in their arsenal to help them deliver better care and potentially save lives. By using a newly developed camera that connects easily to existing technology, doctors working with trauma cases in extreme conditions with only a basic Internet connection could quickly access advice and support from remote sources. The setup also can be used to teach deployed medical personnel new procedural techniques and for continuing education, according to

see warm page 26

see scope page 22

Genetics Identify Risk for Addiction And Tailored Treatment Plans for Pain Miami—For individuals presenting with pain, health professionals at pain clinics could tailor treatment strategies by assessing a patient’s genetic risk for addiction, monitoring for misuse or abuse of prescription medication, evaluating emotional honesty and possibly prescribing a D2 agonist to “increase dopamine sensitivity,” according to a new study. “People are going to pain centers and their physicians are prescribing pain medications but maybe they don’t realize that some patients have genes that predispose them to addiction,” said

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Kenneth Blum, PhD, a lead researcher involved in the study. He presented the findings at the 2012 fall meeting of the American Society of Regional Anesthesia and Pain Medicine. The study examined four components, each of which addresses different aspects of the nature of addiction. Researchers described the incorporation of these factors into a new treatment regimen as “a novel, neuro-therapeutic approach” that they have named the Reward Deficiency Syndrome Solution System. see pain genes page 36

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INSIDE 06 | PRN Physicians blame burnout on bureaucratic headaches.

18 | CLINICAL ANESTHESIOLOGY Age of red blood cells linked to postoperative delirium.

34 | PAIN MEDICINE Nerve damage tied to higher risk for surgical site infections.

40 | AD LIB Anesthesia and the search for enlightenment.

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Heard Here First:

Comment on these and other articles @ AnesthesiologyNews.com.

I spend a lot of time inputting patient information, yet I get a worse record, whereas in the past it took five minutes to dictate a summary of the patient visit. SEE ARTICLE ON PAGE 6.

July 2013

The five most-viewed articles last month on AnesthesiologyNews.com 1. Marathon Bombing Put Local Anesthetists to Grim Test 2. Perioperative Approach to Patients With Opioid Abuse and Tolerance (Educational Review) 3. Telomere Length Linked to Fibromyalgia Pain 4. Liver Transplant Anesthesia Guidelines a ‘Landmark’ 5. Current Concepts in the Management of the Difficult Airway (Educational Review)

May Showers (of Corrections) Editor’s note:

egarding the article, “Walking Epidural Reduces Rate of Cesareans With No Loss of Pain Relief” (May 2013, page 36): A reader has noted that the study on which this article was based failed to achieve statistical significance in the comparison of rates of cesarean deliveries for the anesthetic techniques described. As stated in the article, 53 of 420 patients in the “walking” epidural arm underwent cesarean delivery, whereas 65 of 420 patients underwent cesarean delivery in the control arm, corresponding to proportions of 0.126 and 0.155, respectively. This difference corresponds to a two-sided P value of 0.2747 as analyzed by the Pearson chi-square test and is not statistically significant at the 0.05 level. The authors of the original study acknowledged that this analysis failed to achieve statistical significance. Anesthesiology Newss thanks Thomas Austin, MD, assistant professor of pediatric anesthesiology at Vanderbilt University Medical Center, in Nashville, Tenn., for this observation.

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The commentary, “Suite Strife, Offing Older Anesthesiologists” (May 2013, page 8), misidentified the singer of The Who’s hit, “My Generation.” It was Roger Daltrey, not Pete Townshend. Anesthesiology News s regrets the error. Due to an editing error, the article “Researchers Probe Causes of Opioid Infusion Errors in Peds” (May 2013, page 38), misstated the findings of the study. The majority of incidents occurred in children who were not under the care of the institution’s acute pain service. Anesthesiology News s regrets the error.

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Bureaucracy Main Culprit in Physician Burnout Survey outlines rates, reasons among different specialties

nesthesiologists experience high levels of burnout, due in large part to an overabundance of bureaucratic tasks and overwhelming work hours, according to findings from Medscape’s 2013 physician lifestyle survey. The online survey collected responses from 24,216 U.S. physicians in 25 specialties. Medscape defined burnout as feeling any or all of the following: cynicism, loss of enthusiasm for work or low sense of personal accomplishment. These findings match well with a 2012 national survey on physician burnout, which found that about 45.8% of physicians experienced at least one symptom of burnout ((Arch Intern Medd 2012;172: 1377-1385). And they find an echo in a recent survey by The Physicians Foundation—a nonprofit group— which found that 84% of doctors believe the medical profession is “in decline,” and that more than half said they would not recommend it as a career. Anesthesiologists ranked sixth among the 10 specialties that reported the highest rate of burnout, at 42% of those surveyed. Emergency medicine (52%) and critical care (50%) took the top two spots. Gastroenterologists were among 10 specialties that experienced the lowest percentage of burnout, which included pediatricians (35%), psychiatrists (33%) and pathologists (32%). In terms of severity of burnout, anesthesiologists ranked in the middle, with a mean score of about 3.75 (1 being “does not interfere with my life” and 7 being “so severe that I am thinking of leaving medicine altogether”). OB/GYNs, at 4.1, and pathologists, at 4, ranked the highest in the survey. Too many bureaucratic tasks and hours at work as well as the impact of the Affordable Care Act topped the list of main stressors leading to burnout, garnering scores above 4.5 (1 meaning “not at all important”

and 7 meaning “extremely important”). The leeast important stressors for both specialties were prroblems with employers, compassion fatigue and diifficult colleagues or staff (Figure). “The introduction of EMR [electronic mediical records] has contributed to the problem of physician burnout to the extent that some of my colleagues have quit because of it,” said Robertt J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery at Creighton University School of Medicine, in Omaha, Neb. “EMR has increased the amount of paperwork tremendously, and what’s particularly disturbing, EMR is a poor way of keepiing records.” Dr. Fitzgibbons noted that the electronic forrms often provide choices that do not adequately refllect patient information and each form takes about 30 minutes to fill out. After seeing 25 patients a day, Dr. Fitzgibbons has hours of paperwork to complete at home. “I spend a lot of time inputting patient information, yet I get a worse record, whereas in the past it took five minutes to dictate a summary of the patient visit,” he said. Dhruv Khullar, class president at the Yale School of Medicine and a student at Harvard University’s Kennedy School, agreed that many factors contribute to burnout—namely high workloads, long hours, loss of autonomy and an increasing amount of administrative work—but believes these are symptoms of a greater problem. “I think what’s at the heart of the problem is that these challenges make it difficult for trainees and physicians to continue to focus on the reasons they got into the profession,” he said. “In the midst of the day-to-dayy grind, it can be easy to lose one’s enthusiasm and drive for providing the highest-quality, y compassionate care.”

Too many bureaucratic tasks Spending too many hours at work Present and future impact of the Affordable Care Act Feeling like just a cog in the wheel Income not high enough Lack of professional fulfillment Inability to provide patients with quality care Too many difficult patients Increasing computerization of practice Difficult colleagues or staff Compassion fatigue Difficult employer 0 1 2 Not at all important

Figure. Causes of physician burnout. Source: Medscape.com

5 6 7 Extremely important

The Medscape survey found that female anesthesiologists were substantially more likely than their male counterparts to report signs of burnout—56% versus 42%. That was consistent with most specialties; female general surgeons, for example, appeared to be slightly more burned out than their male counterparts (43% vs. 39%). Medscape proposed that women may experience greater burnout because of more conflicts between work and home life. In terms of physical health, the survey found that burned-out physicians tended to weigh more and exercised less than their less stressed counterparts: 55% of burned-out general surgeons reported being overweight or obese (vs. 46% of their peers not experiencing burnout), and 55% of burned-out general surgeons claimed to exercise two times per week (vs. 67% of their peers). Drinking and smoking habits as well as religiousness did not appear to be associated with level of burnout. Other studies examining physician lifestyle have observed emotional exhaustion to be a major reason for physician burnout. A 2009 study that surveyed 3,233 general surgeons and 4,628 surgical subspecialists found that 41% of general surgeons reported burnout, which included high levels of emotional exhaustion and depression and low ratings of mental quality of life (Ann ( Surgg 2009;250:463-471). Another study that looked at the degree of stress and burnout in 410 endoscopists found that emotional exhaustion was the major contributor to burnout, reported in 30% to 63% of respondents ((Am J Gastroenterol 2011;106:1734-1740). The complexity of procedures and age were also main reasons for burnout, with interventional GIs and younger attendings reporting higher levels. Effect of Burnout Although the impact of burnout is not well understood, it may be serious, in some instances resulting in medical errors and physicians leaving medicine. “We do not know the full impact of stress and burnout in gastroenterologists, but prior studies have shown that higher levels of burnout tend to result in see burnout page 8

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CONTINUED FROM PAGE 6

early retirement; thus, those physicians with the most experience may prematurely leave medicine,” said Rajesh N. Keswani, MD, assistant professor in medicine-gastroenterologyy and hepatology at Northwestern University Feinberg School of Medicine, in Chicago. “Even more concerning, it has been suggested in the surgical literature that higher levels of burnout were associated with medical errors (although unclear if

the burnout was the cause of increased errors).” Supporting this idea, a survey of more than 7,900 members of the American College of Surgeons showed that the number of hours worked and nights on call per week have a strong impact on surgeons’ level of burnout, depression and career satisfaction ((JACS 2010;211:609-619). For instance, surgeons who worked more than 80 hours per week reported more medical errors than those who worked fewer than

60 hours per week (10.7% vs. 6.9%; P<0.001), and these overworked surgeons were twice as likely to attribute the error to burnout (20.1% vs. 8.9%; P=0.001). “There is an unhealthy scarcity mentality that is becoming pervasive in health care systems. Not enough patients, money, time, reimbursements, etc.,” said Henry Kuerer, MD, PhD, professor of surgery at the University of Texas MD Anderson Cancer Center, in Houston. “Hospitals and their

Emergency Medicine Critical Care Family Medicine OB/GYN & Women’s Health Internal Medicine Anesthesiology General Surgery Neurology Urology Nephrology HIV/Infectious Diseases Orthopedics Oncology Diabetes & Endocrinology Pulmonary Medicine Cardiology Gastroenterology Radiology Dermatology Rheumatology Pediatrics Ophthalmology Psychiatry & Mental Health Pathology 0%

10%

physicians are afraid that they will not be able to compete. To some extent this promotes innovation, but also has the risk of demoralizing and demotivating not only physicians but all employees in the system.” Burnout Survey and Beyond Commenting on the usefulness of the Medscape survey, Dr. Fitzgibbons said, “I don’t put much faith in these questionnaires because they’re not objective enough. I could see myself answering the questions very differently from one day to the next.” But, he added, “I think burnout is an important issue, which is on the increase as medicine changes.” Lawrence Cohen, MD, a gastroenterologist and clinical professor of medicine at Mount Sinai School of Medicine, New York City, believes the survey overrated the number of GIs who suffer from burnout based on how Medscape defined the term. “I define physician burnout as physical and emotional exhaustion combined with diminished sense of personal satisfaction and accomplishment,” said Dr. Cohen. “Based upon my anecdotal experience, I would say that fewer than

Burnout at Both Ends of the Spectrum

lthough older anesthesiologists are more likely to experience burnout, according to a recent Medscape survey, the problem also afflicts newcomers to the profession. More than four in 10 anesthesia residents reported emotional exhaustion and other risk factors for burnout, a new study has found. Residents who experienced symptoms of burnout and depression were more likely to report having made a medication error within the past year, and said they were less attentive to

20%

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Figure 2. Percentage of Physicians Reporting “Burn Out”

as mentors to prevent burnout in junior colleagues.” Mr. Khullar believes that an important component of the solution is to create an environment that focuses on the importance of patient care and allows doctors to process and feel energized by these encounters. “At my medical school, there was an option to attend weekly sessions at which students discussed what they were enjoying or struggling with in their training,” he said. “Similarly, a friend

recently told me of an attending that always made sure his team took time to thoroughly discuss a patient’s death or other difficult experiences on the wards. Things like that go a long way [toward] preventing burnout and maintaining professional satisfaction.” Dr. Maaa agreed that acknowledging burnout in colleagues and oneself may help reduce it, but he also proposed taking actions that extend beyond the hospital. “I believe the crucial next steps are for surgeons to vigorously engage in the

health care reform debate, and pave new career paths and goals, particularly in the fields of government and public policy,” he said. Although the problem of burnout is important, what keeps Dr. Fitzgibbons motivated is simple: loving the job. “One can always complain, but in the end being a surgeon is a wonderful job,” he said. “I would never want to have another career.”

Source: Medscape 2013

30%

40%

50%

60%

10% of GIs [not 37%] suffer from true burnout. While I do believe that the vast majority of GIs are working harder than previously, they remain fully engaged in their professional activities, are satisfied emotionally and continue to be rewarded intellectually.” John Maa, MD, director of the surgical hospitalist program at the University of California, San Francisco, said such surveys can be helpful if they “provide constructive feedback on how to make improvements” and “raise awareness with patients, the federal government and other quality improvement organizations of the demands being placed upon physicians across specialties.” The key next step to understanding the problem of physician burnout is developing ways to combat it. Many studies have demonstrated that the increased levels of burnout in physicians may be reversible with a variety of focused interventions. “The studied interventions generally consist of counseling and mindfulnessbased stress reduction exercises,” Dr. Keswani said. “Perhaps more intriguing is the potential use of senior physicians their patients in general—possibly with harmful consequences. The survey of 1,508 anesthesia residents, found that 22% had symptoms of depression, and 17% were at risk for both depression and burnout. Working more than 70 hours a week, being female and consuming more than five drinks per week were linked in an increased risk for burnout and depression. The findings, from Gildasio S. de Oliveira Jr., MD, and his colleagues of Northwestern University in Chicago, appear in the July issue of Anesthesia & Analgesia. —AN Staff

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Unsafe Injection Practices Remain All Too Common

velyn McKnight, AuD, has firsthand knowledge of the devastating consequences of unsafe injection practices. In 2001, she contracted hepatitis C while undergoing chemotherapy for her recently diagnosed breast cancer. An investigation into the source of Dr. McKnight’s infection by the state health department and Centers for Disease Control and Prevention (CDC) uncovered “dumbfounding and unsettling” findings, she said. For 16 months, a clinic nurse had been reusing syringes to draw saline solution from a common IV bag during port-flushingg procedures in advance of administering chemotherapy. In the process, hepatitis C virus (HCV) infection from a previously infected patient was spread to 99 others. “The irony is that I traded one life-threatening disease for another,” Dr. McKnight, founder of HONOReform Foundation, a national advocacy organization dedicated to safeguarding injection practices, said during a recent Institute for Safe Medication Practices (ISMP) webinar on safe injection practices. Matthew Fricker, RPh, MS, program director at ISMP, said he worries that outbreaks like the one Dr. McKnight was involved in are only the tip of the iceberg and many others remain unreported. Results from the 2011 ISMP Medication Safety

Self Assessment for Hospitals support this concern, he said. Of the more than 1,300 hospitals that completed the assessment, 2% had not implemented a policy prohibiting the use of multiple-dose vials for saline and heparin flush solutions or for local anesthetics at all, and 24% had only partially implemented such a policy. Two percent had only partially implemented a hospital-wide policy prohibiting the reuse of the same syringe in more than one patient, even if the needle had been changed between patients. According to Mr. Fricker, 2% may seem like an insignificant number, but when it comes to injection practices, small mistakes can have significant consequences. “We need to be at 100% adherence for these practices,” Mr. Fricker emphasized. Recent reports of insulin pens being reused— including one reported one day before this writing (Whitman V. “Catskill hospital warns that insulin pens may have been reused” Times Herald-Record, d May 21, 2013)—have placed nearly 5,000 patients at risk for HIV, hepatitis B virus (HBV) or HCV infections, Mr. Fricker noted. In the ISMP hospital assessment, 9% of hospitals said they had not taken any formal

Injection Safety Guidelines From CDC Q Never administer medications from the same syringe to more than one patient, even if the needle is changed. Q After a syringe or needle has been used to enter or connect to a patient’s IV it is contaminated and should not be used GPS another patient or to enter a medication vial. Q Never enter a vial with a used syringe or needle. Q Never use medications packaged as single-dose vials for more than one patient. Q Assign medications packaged as multidose vials to a single patient whenever possible. 7 solution as a DPNNPO Q Do not use bags or bottles of *7 source of supply for more than one patient. Q Follow proper infection control practices during the preparation and administration of injected medications. Q Wear a surgical mask when placing a catheter or injecting material into the spinal canal or subdural space. Adapted from: Guideline for isolation precautions: preventing transmission of infectious agents in health care settings 2007. Atlanta, GA: US Department of Health and Human Services, CDC; 2007. http://www. cdc.gov/IJDQBD QEG isolation/isolation2007.pdf

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‘We need to train our providers just to read the label. Unless it is a

significant effort,” Dr. Perz told ISMP webinar attendees. “We need to train our providers just to read the label. Unless it is a manufactured vial with the term “multidose vial” printed on it, it is not a multidose vial.” Results from a 2010 survey of 5,000 health care workers, most of whom were nurses, illustrates the disparity between how well clinicians believe they are doing in preventing infections and how they behave, Mr. Fricker said ((Am J Infect Control 2010;38:789-798).

Although most respondents said they followed recommended infection control practices, 6% said they sometimes or always used single-dose vials for multiple patients and 1% said they reused a syringe for more than one patient after discarding the needle. “There is a misconception that changing a needle is enough to be safe,” Mr. Fricker said. “Many of these respondents were unaware of the risk for spreading disease after changing a needle but reusing the same vial.”

Dr. Perz urged webinar attendees to share the CDC’s Injection Safety Checklist (www.cdc.gov/injectionsafety) and to visit ONEandONLYcampaign. org for free staff training activities, brief how-to videos and posters emphasizing the importance of using single-dose vials and insulin pens in only one individual. “I don’t think we can do enough to educate providers on what safe practices are,” Dr. Perz concluded. —David Wild

manufactured vial with the term “multidose vial” printed on it, it is not a multidose vial.’

high in botic risk is When throm thrombin deficiency ti hereditary an

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—Joseph Perz, DrPH steps to implement a policy prohibiting the use of multidose pens as unit stock. The misuse of insulin pens has prompted the ISMP to recommend that hospitals consider transitioning away from using pen devices. “Issuing this recommendation was not a decision we made lightly,” Mr. Fricker said. A look at the outbreak of HCV that occurred in Las Vegas in 2008 illustrates how reuse of syringes and singledose vials can lead to rapid exposure to infectious diseases in large numbers of individuals, Joseph Perz, DrPH, team leader in ambulatory and long-term care in the Prevention and Response Branch in the Division of Healthcare Quality Promotion at the CDC, told webinar attendees. That outbreak started with a clean needle and syringe that had initially been used to draw from a single-use vial and administer the medication in an HCVV infected patient. Backflow from the injection or from the removal of the needle contaminated the syringe, which was then reused to draw medication from the single-use vial, contaminating the vial and initiating a chain of infection transmission. “What happened there was not unique to Vegas,” Dr. Perz said during the webinar. “We see this over and over.” Need for Education Dr. Perz said many of these lapses in safe practice reflect a lack of understanding as to what constitutes safe injection practices. “To even get nurses to recognize the difference between a single- and multiple-dose vial requires

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Modular PALS Course More User-Friendly for Clinicians

f anesthesiologists and nurse anesthetists find that the current full-day requirements for renewing their certification in Pediatric Advanced Life Support (PALS) are onerous, a customized modular program from Children’s Hospital of Philadelphia may ease the burden. The developers of the new program said practitioners taking the course

preferred it to the traditional PALS format, with no sacrifice in outcomes. “The American Heart Association [AHA] is looking for newer, alternative ways of presenting the information for the PALS certification process,” said Aditee Ambardekar, MD, clinical assistant professor of anesthesiology at the hospital. “There are a couple of shortcomings with

THROMBATE

III®

Antithrombin III (Human) BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII). THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains no preservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Antithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by ATIII proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in the absence or near absence of ATIII. The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with ATIII levels of 40%–60% of normal. These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery. The frequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administered based on immunologic ATIII assays, and 1.4% per unit per kg administered based on functional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of ATIII. These values are similar to the half-life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. In clinical studies of THROMBATE III, none of the 13 patients with hereditary ATIII deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures. Eight patients with hereditary ATIII deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary ATIII deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ⱖ 3 months demonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B. INDICATIONS AND USAGE THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

PALS certification that we find particularly interesting. First, there is degradation of knowledge over the two-year recertification period. And second, the course itself is developed for general practitioners, not anesthesia providers.” With that in mind, Dr. Ambardekar and her co-investigators reformatted a PALS refresher to be more

Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. ATIII in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary ATIII deficiencies. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. CONTRAINDICATIONS None known. WARNINGS Because THROMBATE III is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for THROMBATE III. Inform patients that THROMBATE III is made from human plasma and may contain infectious agents that can cause disease. While the risk that THROMBATE III can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807]. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. PRECAUTIONS General 1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. 2. Administer only by the intravenous route. 3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. 4. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures. The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. Laboratory Tests It is recommended that ATIII plasma levels be monitored during the treatment period. Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays. Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chest discomfort (3), nausea (3), dysgeusia (3), chills (2), pain (cramps) (2), dyspnoea (1), chest pain (1), vision blurred (1), intestinal dilatation (1), urticaria (1), pyrexia (1), and wound secretion and hematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. CAUTION & only U.S. federal law prohibits dispensing without prescription.

Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1871

relevant and user-friendly by dividing it into four hour-longg sessions delivered every three months. Each session addressed respiratory, cardiac, shock or testing scenarios, using high-technologyy manikins to simulate emergency events relevant to anesthesiology. After completing the course, 17 pediatric anesthesiologists and 12 CRNAs completed a survey comparing their experience between the new and traditional formats. After completing the modular course, participants scored a mean 30.28 out of 33; two scored below 84% but were able to raise their scores with extra training. Dr. Ambardekar said she was not particularly surprised to find that clinicians said the new format was both more satisfactory and more helpful than the traditional course. Indeed, although they rated their satisfaction with previous PALS courses at 4.5 on a 7-point scale, they gave the modular course a mean rating of 6.4. When asked how well the course met their learning needs, respondents rated the traditional PALS format at 4.9, compared with 6.5 for the modular format. “We have a wide variety of practitioners here, and we think across the board that people were very pleased with the new course. I also think people like having more of a handson approach,” said Dr. Ambardekar, whose group presented the results at the 2013 annual Pediatric Anesthesiology meeting (abstract O2-79). “The traditional format—although very good—includes a lot of classroom and textbook-type review,” she continued. “Ours, on the other hand, is largely simulation-based scenarios that are anesthesia-specific and allow people to use their hands.” Participants also appreciated an hourly commitment every quarter, which was much easier to fit into their busy schedules than a full day every two years. The researchers’ next step is to perform a randomized controlled trial comparing participants’ learning outcomes between the traditional and modular courses. “I guess the criticism of our course could be that it’s anesthesia-specific and may not be translatable to, say, a neonatologist or pediatric surgeon,” Dr. Ambardekar added. “So we would certainly have to think of ways to manipulate the scenarios to keep them relevant. But the see PALS page 15

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Prototype Shields Pacemakers From Magnetic Drapes But expert questions importance of phenomenon

agnetic drapes are intended to help clinicians in the operating room manage their instruments during surgery, but the magnets may interfere with pacemakers and defibrillators, according to new research. Magnetic drapes interfered with pacemakers in two-thirds of patients tested in a small blinded trial headed by LouisPhilippe Fortier, MD, head of anesthesiology at Maisonneuve-Rosemont Hospital, which is affiliated with the University of Montreal, in Canada. But a prototype of the shielded magnetic drapes created no electromagnetic interference with pacemakers. “There’s the potential for very significant events during surgery,” said Dr. Fortier, whose group presented its findings at the 2013 annual meeting for the Society for Technology in Anesthesia (abstract 9). In a 1992 case study cited by Dr. Fortier’s group, the heart rate of a

pacemaker wearer switched repeatedly from 99 to 116 back to 99 because of a magnetic drape placed on his thorax. At one point, the patient went into asystole for three seconds. Researchers concluded that the pacemaker went into ventricular threshold test because of the magnetic drape. The group reported four main problems from magnetized drapes: battery depletion; rapid pacing in patients with coronary disease; R on T stimulation (ventricular fibrillation caused by stimulation during the repolarization phase of the cardiac cycle); and arrhythmia detection and treatment suspension for implanted defibrillators. For their study, Dr. Fortier and his colleagues compared magnetic drapes with the shielded prototype in 27 volunteers with pacemakers. The researchers monitored how often the pacemakers entered into magnet mode, an indicator of magnetic interference.

In 17 of the patients, the magnetic drapes caused electromagnetic interference, whereas none of the patients experienced pacemaker changes with shielded drapes. “The primary cause of electromagnetic interference in the operating room is electrocautery and surgeons are aware of this issue,” said Jeff Healey, MD, a cardiac specialist at McMaster University in Hamilton, Ontario, Canada, who was not involved in the study. “This is not that scary an issue because surgeons are already dealing with the possibility of electromagnetic interference. If a patient is properly prepared for surgery, there should be a very small chance of significant clinical consequence.” Dr. Fortier said that magnetic drapes are common in his experience, but their popularity remains unclear. The Canadian Cardiovascular Society, the Canadian Anesthesiologists’ Society and the Canadian Heart Rhythm

Society made safety recommendations for perioperative pacemaker safety in April 2012 that did not address magnetic drapes. Dr. Healey, y who was the lead author on the position paper, said he had not heard about magnetic drapes until recently. Magnetic drapes, a surgical convenience, are marketed under brand names such as Devon, Converters, Insta-Hold and Kendall. Dr. Fortier’s team tested four commercially available magnetic drapes and found a wide range of pacemaker interference. One unnamed brand interfered in 18 of 20 patients. Another brand interfered in one of 20 patients tested, the researchers found. The idea for the new drapes came in 2008 when Dr. Fortier noticed an electrocardiogram change when a magnetized drape was put on a patient’s thorax during routine laparoscopic cholecystectomy. see drapes page 15

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Super-Selective Scalp Block Goes The Distance for Awake Craniotomies

n innovative approach to super-selective scalp block that delivers local anesthetic in a bolus instead of by infiltration permits prolonged analgesia during awake craniotomies, researchers have found. “The technique has allowed us to keep the patient relatively comfortable for resection and helps to preserve the patient’s speech and function, [thus] allowing for neuro-monitoringg intraoperatively,” said Anh-Thuyy Nguyen, MD, clinical associate professor of anesthesiology and perioperative medicine at the University of Texas MD Anderson Cancer Center, in Houston. “It lets us keep patients who are undergoing awake craniotomies to be pain-free for a prolonged period of time.” MD Anderson is a major referral center for resection of insular tumors. Dr. Nguyen, lead author David Ferson, MD, and their colleagues studied 37 patients who underwent the cranial surgery under the scalp block technique. To perform the super-selective scalp block, clinicians injected a 2 to 4 mg/kg bolus of 0.5% ropivacaine with epinephrine 1:200,000. The aim of the anatomically guided technique is to increase the concentration of the local anesthetic close to the smalldiameter nerves that innervate the scalp. They found that analgesia lasted 10 hours or longer; the average surgery time was 12 hours (range, 10 to 17 hours). The super-selective scalp block generally obviates the need to re-inject local anesthetic during surgery, the researchers said. That durability offers a clinical advantage, they noted, because traditional infiltration scalp blocks last only two to six hours. In the study, the technique permitted awake, intraoperative neurologic monitoring for an average of 159 minutes (range, 30 minutes to seven hours). “We were surprised that the block could last so much longer than the anticipated six hours per the Advertisement

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ropivacaine package insert,” said Dr. Nguyen, who presented the findings at the 2012 annual fall meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 61). “Because this was a retrospective chart review study, we had already observed the results individually but not in so many patients.” ‘Almost Foolproof’ “The technique is deceptively easy. It requires a good understanding of neuroanatomy and attention to detail,” Dr. Ferson, professor of anesthesiology and neurosurgery at MD Anderson, told Anesthesiology News. He estimated that clinicians must place between 50 and 100 blocks to become proficient in the approach. “The secret is to practice the block and optimize the technique, so it gives the optimal coverage for surgeries lasting more than 10 hours.” “Once the anatomy and technique is mastered, the block is almost foolproof,” Dr. Nguyen added. The complete analgesia provided by the technique also eliminates the need for sedatives and opioids during neurologic testing. A clinical tip for other anesthesiologists considering the super-selective block technique is to proceed with caution when injecting the auriculo-temporal nerve. Stay high to avoid inadvertent injection into the facial nerve. Dr. Nguyen said this is important “so one does not accidentally inject the lower branch of the facial nerve and inadvertently cause a facial droop.” Dr. Ferson said accidental injection of the zygomaticotemporal branch of the trigeminal nerve also can occur. This branch of the nerve is closer to the facial nerve than the auriculo-temporal nerve, and he added: “If one is not careful, it could be a double strike.” If facial nerve droop is a potential complication, it may be difficult to distinguish whether this outcome was caused by the block itself or an intervention by a neurosurgeon near a critical structure, said Lois O’Brien, MD, an anesthesiologist formerly on the faculty at the University of California, Los Angeles, and Stanford University, and now in private practice in Los Angeles. “If a facial nerve droop occurred after the administration of the bolus, would the operation have to be postponed until the effect of the bolus wore off, perhaps a minimum of 10 hours? “Is this technique better, safer, easier, less likely to confuse the neurologic picture intraoperatively, in terms of motor function and speech, than the technique of scalp infiltration? Does it offer any significant benefit over the infiltration technique?” Dr. O’Brien asked. “I am not convinced that it does, and it may have significant negatives.” Facial droop is a potential negative, Dr. O’Brien said, because it would require surgery to be postponed at least 10 hours for the block to fully wear off. “What is relevant is to be able to monitor the patient’s neurologic status intraoperatively and postoperatively. Anything that interferes with this is

‘Is this technique better, safer, easier, less likely to confuse the neurologic picture intraoperatively, in terms of motor function and speech, than the technique of scalp infiltration? Does it offer any significant benefit over the infiltration technique?’ —Lois O’Brien, MD

Testing a patient’s motor skills during an awake craniotomy. Image courtesy of Ramin Rak, MD.

counterproductive and confusing.” In addition, the relatively small number of participants was a limitation of the study. Dr. O’Brien also estimated that “a learning curve of 50 to 100 blocks [would be required] for each anesthesiologist to be proficient in this block.” A future trial that compares the pain relief provided by the super-selective nerve block and by scalp infiltration for awake craniotomy could resolve some unanswered questions, Dr. O’Brien said. The focus of the current study was limited to pain control during surgery, Dr. Nguyen said. “We have been using this block intraoperatively and not so much for postoperative pain control, even though the block does last through the postoperative period.” In the first 24 hours postsurgery, patients reported low pain scores on a visual analog scale and used a low amount of pain control medications, according to their review of anesthesia, medical and surgical records. “In our analysis, we have observed a definite trend of better pain control in the postoperative period in patients who received a super-selective scalp block,” Dr. Ferson said. “Until recently, the pain after craniotomy has been underestimated, so we are very excited to study the effects of the scalp block for pain control after craniotomies.” —Damian McNamara

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CL IN ICA L A N E STH E SIOL OG Y

For Intubations, the Weight Is the Hardest Part— But a Lot Easier Than It Used To Be Washington—Intubating obese and morbidly obese patients has become so commonplace in recent years that most anesthesiologists are comfortable with the challenges these patients present. Indeed, although clinicians once approached such cases with trepidation, the majority do not present any more risk for bad outcomes during surgery than their normal-weight counterparts—provided certain guidelines are followed. “The [American Society of Anesthesiologists] describes a difficult airway as a clinical situation in which a trained anesthesiologist has a problem with face-mask ventilation, tracheal intubation or both,” said Jay B. Brodsky, MD, clinical professor of anesthesia at Stanford University School of Medicine in Stanford, Calif. Most morbidly obese patients can be difficult to ventilate by mask, particularly if they lie flat during a procedure, acknowledged Dr. Brodsky, y who reviewed the literature on intubating overweight patients at the 2012 annual meeting of the American Society of Anesthesiologists. Yet a study of more than 22,000 patients found that in only about 350 cases were two people required to perform mask ventilation ( (Anesthesiology 2006;105:885-891). The study also found that body mass index (BMI) was the strongest independent risk for requiring two providers to mask ventilate (P<0.0001). “So there’s no question that many morbidly obese patients can be a little more challenging to mask ventilate,” he said. A British national audit also pinpointed aspiration as a very real risk in obese and morbidly obese individuals, although determining its risk factors is not so straightforward (Br J Anaesth 2011;106:617-631). “Obese patients have increased abdominal pressure, particularly during laparoscopy,” Dr. Brodsky explained. “And many obese patients are diabetic and have gastroparesis, along with a higher incidence of hiatal hernia.” The audit examined airway management in all National Health Service hospitals for one year. Researchers found that obese patients had twice the risk for developing serious airway problems during anesthesia as normal-weight patients; patients with “severe” obesity were four times as likely to develop such problems. Perhaps not surprisingly, obese patients had increased frequency of aspiration and other complications during the use of supraglottic airways (SGA). “You really need justification for using an [SGA] in morbidly obese patients,” Dr. Brodskyy noted. “These patients have a higher risk for aspiration, at least with the first-generation supraglottic airways.” Yet whether elevated BMI, increased neck circumference, a higher Mallampati score (III and IV) or all three are at the root of difficult intubation in morbidly obese patients, proper patient positioning can make any situation easier. Indeed, Dr. Brodskyy and

his colleagues found that residents at various stages of training successfully intubated 92% of 100 morbidly obese patients (BMI >40 kg/m2) on the first attempt ((Anesth Analgg 2002;94:732-736). The trick, he said, was elevating the head and upper body. “If you leave [with] one message from this talk, it’s that you should place that patient’s head and upper body in what we call the ‘head-elevated laryngoscopy position,’” he said. “When properly positioned, an imaginary horizontal line can be drawn from the sternum to the ear. And if the blood pressure tolerates it, put the operating room table in the reverse Trendelenburg position. This maximizes the time you have to intubate the patient and gives you the best view possible during direct laryngoscopy.”

PALS

As with any procedure, preparation and vigilance are vital parts of safely intubating any patient, and Dr. Brodskyy recommended the availability of rescue devices. “I think one of the greatest tools we have is the gum elastic bougie,” he said. “If we have a resident who can see the vocal cords but can’t place the endotracheal tube on the first try, I tell them to not bother banging away a second time, just use the bougie as a guide.” At the hint of a difficult intubation, a fiberscope or video device is always an option, he added. “Finally, you should always have an assistant available to help, because tracheal intubation is not a one-man show,” he said. “There always has to be help nearby.” Roman Schumann, MD, associate professor of anesthesiology and vice chair for academic affairs at Tufts University, in Boston, agreed that prudence is warranted when intubating an obese patient. “Although this population presents with a higher frequency of features that would be suggestive of a difficult airway, daily practice has taught us that airway management turns out to be straightforward in a surprising percentage,” Dr. Schumann said. “Just as for the general surgical population, the holy grail of reliable prediction of the difficult airway has remained elusive for the morbidly obese,” he added. “Experience, skillful manual airway management expertise and a thoughtful approach remain of paramount importance to prevent airway management failure in this vulnerable population.” —Michael Vlessides

DRAPES

CONTINUED FROM PAGE 12

foundation is there, and developing specialtyspecific scenarios wouldn’t be too difficult.” Elaine Ng, MD, staff anesthesiologist at The Hospital for Sick Children in Toronto, Ontario, Canada, noted that studies have demonstrated that retention after traditional advanced life support courses typically does not last much longer than a few months. “Modular format or spaced education may lead to longer retention of information,” she said. “I think we can conclude that learners liked this PALS course,” Dr. Ngg said. “However, there were many other elements—not just the modular format—that may have made it more enjoyable. It would also be interesting to determine if higher forms of learning, such as behavior change or translation to clinical practice, can be achieved, and how they impact interprofessional team function.” —Michael Vlessides

CONTINUED FROM PAGE 13

By 2009, Dr. Fortierr and his colleagues teamed up with Univalor, a Montreal-based technology transfer firm and Menodys, a Longueuil, Quebec-based medical prototype developer to commercialize the product. Dr. Fortier said the device is under patent protection and declined to discuss details of the technology. At Maisonneuve-Rosemont, Dr. Fortier reported, 94% of patients showed signs of interference with the current magnetized drape and that this phenomenon disappeared when the drape was pulled 15 cm away from the original capture position. The Montreal researchers are writing up their results for publication and the hospital currently is using the magnetic drapes. “As soon as our first paper comes out, people will start asking questions about the danger of the magnets that they are using,” Dr. Fortier said. “In the meantime, we will be probably in the final stage of writing a second paper on the prototype and offering to the surgical population an alternative.” —Trevor Stokes

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Subglottic Suctioning Linked to Lower VAP Rates

8 P<0.0001 6

Percent VAP

ontinuous aspiration of subglottic secretions for all cardiac surgery patients receiving postoperative ventilation may reduce rates of ventilator-associated pneumonia (VAP) by up to 65%, Canadian researchers have found. “We think the findings merit further study and discussion of whether subglottic suctioning might be beneficial for all patients, including noncardiac surgery patients, who require ventilation for one or more nights,” said lead researcher Jordan Hudson, MD, assistant professor of anesthesiology at the University of Ottawa. Dr. Hudson said she and her colleagues were “quite surprised” by the size of the reduction in rates of VAP. The investigators presented the results at the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 105). One in four patients in the ICU patients develop VAP, and as many as 25% of infected individuals die from the condition ((Ann Intern Med 2003;138:494-501). In light of the toll VAP takes, a growing number of interventions and quality improvement initiatives have been created to address the complication, with varying levels of success (Healthc Q 2012;15:36-41). In the latest study, Dr. Hudson and two of her colleagues documented changes in VAP rates after 2009, when the University of Ottawa Heart Institute mandated continuous aspiration for all ventilated cardiac surgery patients. They compared data from 2,450 patients between 2009 and 2011 with 2,430 similar patients seen at the hospital between 2007 and 2009 who did not undergo continuous aspiration. Most patients had been extubated within 24 to 48 hours after surgery.

No Suction

Suction

Figure. Patients who received subglottic suctioning were far less likely to develop ventilator-associated penumonia (VAP). According to Dr. Hudson, 5.6% of the nonsuctioned patients developed VAP compared with 1.9% of those who underwent suctioning (P<0.0001). Multivariate analyses controlling for the severity of illness and other VAP risk factors confirmed the strong association between continuous suctioning and a lower incidence of lung infection (odds ratio, 0.342; 95% confidence interval, 0.239-0.49; P<0.0001). Mortality rates among suctioned and nonsuctioned patients were 2.1%, and 3.3%, respectively; however, Dr. Hudson said they were not statistically significant after controlling for risk factors such as severity of illness and type of surgery. Naomi O’Grady, MD, a staff clinician in the Critical Care Medicine Department at the National Institutes of Health (NIH) Clinical Center in Beth hesda, Md., who was not involved in the study, said the

decreases in VAP in the study were impressive. However, Dr. O’Grady noted the study does not demonstrate a causal relationship between suctioning and VAP rates. “The study addresses an important and timely topic and includes a large number of patients, but the before-and-after trial design makes it difficult to say the improvements are solely a result of the investigators’ intervention,” Dr. O’Grady, who is also medical director of the NIH Clinical Center’s Procedures, Vascular Access and Conscious Sedation Services, told Anesthesiology News. Dr. Hudson agreed. “Some of the effects may have been due to the adoption of other VAP prevention measures over the last decade, such as elevation of the head of the bed,” she said. “The findings cannot be generalized because many of the subjects were elective cardiac surgical patients, with a much lower baseline risk for complications than what you would see in a more typical medical or surgical ICU.” Dr. Hudson said a definitively causal relationship between suctioning and reduced rates of VAP should encourage other centers to adopt a policy similar to that of the Heart Institute. Until those findings emerge, however, the added resources required for the procedure may prove too high, she added. “A subglottic suctioning tube is approximately 10 times the cost of a standard endotracheal tube,” Dr. Hudson noted. “As well, you have to pay for the additional manpower of the respiratory therapist or registered nurse who has to perform either continuous or intermittent subglottic suctioning.” —David Wild

I COUGH To Improve Postoperative Pulmonary Care

postoperative pulmonary care program with the evocative acronym I COUGH has shown a trend toward reducing postoperative pulmonary complications, although these results did not reach clinical significance. To reduce postoperative pulmonary complications at their institution, the Boston University Medical Center, a multidisciplinary pulmonary care group developed a set of six inexpensive, relatively simple and easily understood techniques: Incentive I spirometry; Coughing and deep breathing; Oral care (brushing teeth and using mouthwash twice daily); Understanding (patient and family U

education); Getting out of bed frequently (at least three times daily); and H -ofHead f bed elevation. The researchers used data from the National Surgical Quality Improvement Program to compare the year before (2009) and after (mid-2010 to mid-2011) implementation of I COUGH among surgical patients. In the year before, the incidence of postoperative pneumonia was 2.6% (1,569 cases); in the year after, the incidence fell to 1.6% (1,542 cases; P=0.09). Risk-adjusted outcomes showed that the observed-to-expected (OE) ratio for pneumonia of 2.13 fell to an odds ratio (OR) of 1.58 after I COUGH. The incidence of unplanned

intubations fell from 2% (1,569 cases) before I COUGH to 1.2% (1,542 cases; P=0.09) after, with riskk adjusted outcomes falling from an OE ratio of 2.10 to an OR of 1.31, according to the researchers, who reported their findings in JAMA Surgery ( June 5; doi:10.1001/ jamasurg.2013.358). Although the pulmonary complication rates exhibited only a trend toward significance, before-and-after comparisons of nursing practice demonstrated significant gains. Audits of nursing practice revealed that 19.6% of 250 patients were out of bed before I COUGH, compared with 69.1% of 250 patients after the program (P<0.001). Prior to I COUGH, only

52.8% of patients had an incentive spirometer within reach; after, the figure was 77.2% (P<0.001). In an invited critique ((JAMA Surg; June 5, 2013; doi:10.1001/jamasurg.2013.375), Bruce J. Leavitt, MD, a surgeon at Fletcher Allen Health Care, in Burlington, Vt., noted that the study had “many positive outcomes” despite failing to achieve statistical significance. “[C]reating a multidisciplinary team that implements simple measures involving the pulmonary care of the surgical patient can improve outcomes and lower medical costs,” Dr. Leavitt wrote. —George Ochoa

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AnesthesiologyNews.com I 17

The following advertorial has been provided by Fresenius Kabi USA, LLC. and is designed to support the advertisement presented below.

NAROPIN® is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Q. How does NAROPIN compare with bupivacaine in terms of motor function? A. NAROPIN, at equipotent doses to bupivacaine, provides faster return of motor function with effective sensory block.1-3 Data show that NAROPIN demonstrated eight to 10 hours faster return 1 of motor function versus bupivacaine (P<0.05). P

concentrations of epidural ropivacaine for cesarean section. Anesthesiology. 1995;82:1346-1352. 5. Crosby E, Sandler A, Finucane B, et al. Comparison of epidural anaesthesia with ropivacaine 0.5% and bupivacaine 0.5% for caesarean section. Can J Anaesth. 1998;45:1066-1071. 6. Griffin RP, Reynolds F. Extradural anaesthesia for caesarean section: a double-blind comparison of 0.5% ropivacaine with 0.5% bupivacaine. Br J Anaesth. 1995;74:512-516.

Q. In the labor and delivery setting, how does NAROPIN compare with bupivacaine?

7. Aşik I, Göktuğ A, Gülay I, Alkiş N, Uysalel A. Comparison of bupivacaine 0.2% and ropivacaine 0.2% combined with fentanyl for epidural analgesia during labour. Eur J Anaesthesiol. 2002;19:263-270. 8. Writer WDR, Stienstra R, Eddleston JM, et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth. 1998;81:713-717. 9. Hickey R, Hoffman J, Ramamurthy S. A comparison of ropivacaine 0.5% and bupivacaine

A. NAROPIN restores motor function faster3-8 and improves labor and delivery outcomes.3,7,8 • 51% of mothers who received NAROPIN had less intense motor block compared with 42% 8 with bupivacaine (P<0.05). P • NAROPIN patients experienced 96 minutes faster recovery of motor function after complete paralysis following C-sections versus 5 bupivacaine (P<0.05). P • NAROPIN produced effective onset of anesthesia, duration of sensory blockade and quality of analgesia.6 • An 18% higher proportion of spontaneous vaginal deliveries was observed in patients who received NAROPIN versus bupivacaine 8 (P<0.05). P • NAROPIN was associated with a 32% lower proportion of instrumented deliveries versus 8 bupivacaine (P<0.01). P

0.5% for brachial plexus block. Anesthesiology. 1991;74:639-642. 10. Rawal N, Allvin R, Axelsson K, et al. Patient-controlled regional analgesia (PCRA) at home: controlled comparison between bupivacaine and ropivacaine brachial plexus analgesia. Anesthesiology. 2002;96:1290-1296. 11. Bertini L, Tageriello V, Mancini S, et al. 0.75% and 0.5% ropivacaine for axillary brachial plexus block: a clinical comparison with 0.5% bupivacaine. Reg Anesth Pain Med. 1999;24:514-518.

ANESTHESIA/ ANALGESIA

Q. How does NAROPIN compare with bupivacaine in terms of efficacy of analgesia and patient satisfaction? A. NAROPIN, at equipotent concentrations to bupivacaine, delivers effective analgesia1,3,9-11 and greater patient satisfaction.3,10,11 • 18% to 52% faster onset of analgesia versus bupivacaine, with an equal mean duration of 13 to 14 hours.9 • Significantly less initial morphine use (2.8 versus 5.9 mg) compared to bupivacaine patients 1 in the post-op recovery room (P<0.05). P • Significantly more patients were satisfied with the analgesic efficacy of NAROPIN—an 81% satisfaction rate versus 52% for bupiva10 caine (P<0.05). P • 93% of NAROPIN patients rated their overall anesthesia experience as excellent versus 11 73% of bupivacaine patients (P<0.05). P

NAROPIN delivers effective analgesia and improves patient satisfaction vs bupivacaine1,2

References

Compared to bupivacaine, NAROPIN delivers:

1. Beaulieu P, Babin D, Hemmerling T. The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. Anesth Analg. 2006;103:768-774.

• Signiﬁcant reduction in the need for opioids2,3

2. Morrison LM, Emanuelsson BM, McClure JH, et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth. 1994;72:164-169.

• Faster return of motor function3-5 • Significantly more patients were satisfied with analgesic efficacy1,2 www.naropin-us.com

3. NAROPIN® Prescribing Information. Data on file. 4. Datta S, Camann W, Bader A, VanderBurgh L. Clinical effects and maternal and fetal plasma

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs. NAROPIN may be associated with adverse reactions which are characteristic of those associated with other amide-type local anesthetics6. In clinical trials, side effects were mild and transient and may reﬂect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com. Please see accompanying brief summary of Prescribing Information.

NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management. References: 1. Rawal N, et al. Anesthesiology. y 2002;96:1290-1296. 2. Bertini L, et al. Reg Anesth Pain Med. d 1999;24:514-518. 3. Beaulieu P, et al. Anesth Analg. 2006;103:768-774. 4. Crosby E, et al. Can J Anaesth. 1998;45:1066-1071. 5. McGlade DP, et al. Anaesth Intensive Care. 1998;26:515-520. 6. NAROPIN Prescribing Information. Data on ﬁle.

18 I AnesthesiologyNews.com

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C LIN I C A L A N ES THES IO LO G Y

Red Blood Cell Age Could Increase Risk for Post-Op Delirium

ransfusing older red blood cells during cardiac surgery may put patients at risk for postoperative delirium, a new study has found. The case–control study, which included more than 160 cardiac surgery patients, showed those who received transfusions of red blood cells (RBCs) that had been in storage for more than three weeks were more than

twice as likely as those who received fresher blood to experience delirium. The study addressed a serious postoperative complication, said Aryeh Shander, MD, president of the Society for the Advancement of Blood Management, who was not involved in the research. However, he said it is only hypothesis-generatingg at this point. “We need to have some kind of

Naropin p

(ropivacaine HCl Injection, USP) BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics followingg arthroscopic p and other surgical g pprocedures is an unapproved pp use,, and there have been ppost-marketingg reports p of chondrolysis y in patients p receivingg such infusions. The majority j y of reported p cases of chondrolysis y have involved the shoulder jjoint;; cases of ggleno-humeral chondrolysis y have been described in ppediatric and adult ppatients followingg intra-articular infusions of local anesthetics with and without eppinephrine p for pperiods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion pperiods are not associated with these findings. g The time of onset of symptoms, y p , such as jjoint ppain,, stiffness and loss of motion can be variable,, but mayy begin g as earlyy as the 2nd month after surgery. g y Currently,y, there is no effective treatment for chondrolysis; y ; ppatients who experienced p chondrolysis y have required q additional diagnostic g and therapeutic p pprocedures and some required q arthroplasty p y or shoulder replacement. p It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does nott ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivoo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

biologic, or chemical or physiologic connection between the two variables, and at the moment there is none,” said Dr. Shander, who is also chief of the Department of Anesthesiology, Critical Care and Hyperbaric Medicine at Englewood Hospital and Medical Center in Englewood, N.J. “The association might have nothing to do with blood age. One possibility is that

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions). Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.) ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin. Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661 N 1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433 N 1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661 N 1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Bupivacaine total N=1433 N 1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

Fresenius Kabi USA, LLC

0517-NAR-05-01/13

Rev. 11/08

transfusion, on its own, may be associated with delirium, but that’s difficult to separate out because there are so many confounders.” The researchers presented their findings at the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 86). Lead investigator Charles Brown, MD, assistant professor of anesthesiology and critical care medicine at The Johns Hopkins University School of Medicine, in Baltimore, and his colleagues set out to investigate the possible correlation between age of blood and delirium in light of prior evidence that transfusion of older blood can increase the risk for other morbidities as well as death.

By the Numbers:

90% % The amount by which the number of surgeries reported to state regulators dropped from 2007 (1,167,583) to 2010 (120,115), after a California court ruled that physician-owned ambulatory surgery centers (ASCs) no longer had to report those data to state health regulators.

98% The number of ASCs in the Golden State owned by investors.

Source: Ambulatory Surgery Centers: Big Business, Little Data; California Health Care Almanac June 2013 [http://www.chcf.org/ publications/2013/06/ambulatory-surgery-centers#ixzz2W83z6Qwp]

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CL IN ICA L A N E STH E SIOL OG Y Dr. Brown and several colleagues analyzed data from 87 patients undergoing cardiovascular surgery who developed postoperative delirium and the same number of matched nondelirious controls. The data were collected prospectively between 2005 and 2011, and all of the patients had received between one and four units of RBCs on the day of surgery or the first postoperative day. In multivariate analyses, Dr. Brown’s group controlled for other risk factors for delirium, including patient age, cerebrovascular disease, cardiopulmonary bypass time and emergent status. They also controlled for units of RBC transfused, as a study from the late 1990s hinted that patients who receive more units might be at greater risk for postoperative delirium ((Am J Med 1998;105:380-384).

Dr. Brown’s team found that individuals who received blood that had been stored for longer than 21 days had twice the risk for developing delirium as those who received fresher blood (odds ratio [OR], 2.24; 95% confidence interval [CI], 1.01-4.97; P=0.048). Each day of additional storage over 21 days increased the odds of postoperative delirium by 12% (OR, 1.12; 95% CI, 1.02-1.23; P=0.02), according to the study investigators.

Dr. Brown noted that the generalizability of the results is limited to patients who receive no more than four units of RBCs. Other design weaknesses also qualify the study’s findings, he added. “It was a case–control design that only included cardiac surgery patients, and delirium was assessed by nurses and research nurses who did not use the most widely validated method, the Confusion Assessment Method,” Dr. Brown explained. “So, the delirium rate was likely underestimated and the

hyperactive forms of delirium may have been preferentially identified.” Despite the study’s limitations, Dr. Brown said the results support his group’s initial hypothesis and the results warrant a larger study using better diagnostic criteria to validate the findings. “We are continuing to assess patients using stricter criteria for delirium,” he said, “so we’ll see what those results show.” —David Wild

Ambulatory Surgery Centers in California

754

The number of ASCs operating in California in 2010.

Whichever Road You Take… B. Braun has the right products to get you there. The number of those facilities that reported data on their surgeries to the state in 2010.

We understand that there are many ways to achieve nerve block success. According to a recent survey, 45.6% of facilities use nerve stimulation alone, 45.7% use a combined “Dual Guidance” approach (stimulation combined with ultrasound) and 8.7% use ultrasound with no stimulation.1

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To find out about our complete range of products and educational services, contact your local B. Braun Sales Representative or call 1-800-227-2862. 1. Viscusi, E, Gandhi, K: Peripheral Nerve Blocks Have Come a Long Way. Outpatient Surgery, Oct. 2009. 170 respondents from hospital & outpatient facilities.

The number that reported data to the state in 2007.

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Protocol Gives Guidance, With Flexibility, For Spinal Fusion Anesthesia

aced with a team of anesthesiologists using a wide variety of approaches to posterior spinal fusion surgery, North Carolina researchers have streamlined their delivery of care by implementing a best-practice guideline.

The ensuing reduction in extubation time and length of stay in the postanesthesia care unit (PACU) testifies not only to the efficacy of the guideline, but the need for anesthesiology departments to revisit existing protocols to maintain

maximum efficiency, according to the researchers. “Our surgeons had noticed that with some providers, in some situations, and with some anesthetics, patients tended to wake up more quickly or more comfortably,” said Katie Beth Reding, MD,

an anesthesia resident at the University of North Carolina at Chapel Hill. With that in mind, Dr. Reding and her colleagues hypothesized that defining specific drug infusions, doses and ranges—as well as setting specific Table. The North Carolina Protocol for Spinal Fusion Surgeries

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CL IN ICA L A N E STH E SIOL OG Y titration parameters—would create more predictable emergence times and possibly decrease extubation times (Table). “The most important thing was that when we wrote the protocol, we wanted to give our providers a guideline for titration,” Dr. Redingg told Anesthesiology News. “So we made it a part of the protocol to use the BIS [bispectral index] monitor [Covidien]. This gave us a well-defined end point by which we could titrate our drugs.” The investigators then reviewed charts to determine what changes, if any, the protocol had on such end points as time to extubation, pain scores and length of stay in the PACU. They reviewed patient records for comparable three-month periods in 2011 (n=26) and 2012 (n=22). Extubation times decreased by 52% after the protocol was implemented, from 13.2 to 6.9 minutes (P=0.005, according to the study team. Length of stay in the PACU also fell significantly, from 131.2 to 106.8 minutes (18.5%; P=0.03). Pain scores were comparable between groups. And although telling anesthesiologists how to practice is not always the easiest of tasks, Dr. Redingg noted that they took the changes in stride. “We wanted to have the protocol approved by our attendings before implementation because we didn’t want to take away their autonomy,” said Dr. Reding, who presented the findings at Pediatric Anesthesiology 2013 (abstract SO2-140). “But all of them agreed to try it for the duration of our study. And then they were all so pleased with our results that as far as I know, every single one of them is still using the protocol.” Dr. Redingg suggested that other institutions consider similar undertakings. “We anesthesiologists take extremely good care of our patients, but there’s always room for improvement,” she said. “Best-practice guidelines give providers a definitive plan to follow by targeting specific goals, and a much more definitive way to measure their outcomes.” Lynn D. Martin, MD, MBA, director of anesthesiology and pain medicine at Seattle Children’s Hospital, agreed that variations in clinical practice are common, largely because there is little evidence to drive clinical decisions regarding best practice. “I believe the authors are pursuing a line of practice that every anesthesia provider should embrace moving forward,” Dr. Martin said. “While building a consensus-based practice has been described as ‘herding cats,’ once established it provides a stable

foundation on which continuous, iterative small-scale tests of change can be done to make incremental improvements in our clinical practice and outcomes. We have been pursuing this very philosophy at Seattle Children’s for the past 10 years and have seen significant reduction in variation and improvements in outcomes. Congratulations to these successful cat herders!”

Contact

the editor of Anesthesiology News

amarcus@mcmahonmed.com

—Michael Vlessides

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anesthesiologist researchers from the Center for Advanced Technology and Telemedicine (CATT) at the University of Nebraska Medical Center (UNMC), in Omaha, who presented their findings at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 562). To test the feasibility of the equipment, the researchers connected a Karl Storz video stylet to the newly developed C-CAM camera, which was attached to the C-Hub, a small box that converts

Researchers used a basic Internet connection and airway technology, including the newly developed C-CAM camera, to enable participants in Nebraska, Spain and Afghanistan to collaborate in real-time on a remote oral intubation performed on a mannikin.

‘It can be used on the fly. It’s quicker, cheaper and gives better images into a format that can be transmitted by computer. This C-Hub was in turn hooked up to a USB computer port to allow online video sharing. A con- accessibility. Not just with anesthesia nection was established between the CATT labbut with combat trauma care.’ oratory in Omaha, the Spanish Army Hospital in Madrid and a far-forward NATO base in Herat, —Thomas Nicholas, MD Afghanistan. The researchers demonstrated the technology by conducting a remote oral intubation on a difficult from the video stylet through the camera and viewed airway manikin. Real-time images were transmitted by participants in all locations, who found the image quality acceptable enough to allow for remote direction of complex tasks. Karl Storz, an international company that develops products to support airway management and other endoscopic-related instruments, manufactured the devices. In practice, doctors could use any video conferencing software, such as Skype, FaceTime or Adobe Connect, the last of which was used in the demonstration. In the past, this kind of video collaboration required expensive T-1 connections and permanent audiovisual setups between institutions. Study coauthor Thomas Nicholas, MD, an anesthesiology instructor at UNMC, explained that the technological advance is groundbreaking because it means that physicians in the trenches with only a basic Internet connection could get the help they need to better deal with difficult intubations and other complex scenarios at a first aid or far-forward station. That efficiency saves precious time and logistics associated with transporting soldiers to tertiary facilities. “It can be used on the fly,” Dr. Nicholas said. “It’s quicker, cheaper and gives better accessibility. Not just with anesthesia but with combat trauma care.” Speedy access to outside support is crucial on the battlefield, where rotating personnel with varying degrees of experience deal with unpredictable and wide-rangingg trauma situations. Normally, when faced with a difficult intubation or other situation in which outside support is needed, the medical worker would have a tough choice of proceeding alone and without help, or deferring treatment further down the line. Any decision to transfer patients for treatment costs the soldier valuable time and can disrupt military logistics if it requires diverting a helicopter or other mode of transport from an operation. The study meshes with related work being done at CATT by the study’s lead author, Ben Boedeker, MD, PhD, professor of anesthesiology at UNMC. A major area of focus for his team is the development and integration of telemedicine technology into real-time airway management telementoring, airway management education and real-time surgical telementoring. Another focus has been the development of web-based applications in perioperative patient management. Jon Linkous, CEO of the American Telemedicine Association, a trade group, said the UNMC C-CAM project fits right into the telemedicine landscape. “This is right up the alley of what we’re seeing across the spectrum in health care,” Mr. Linkous said. “Every specialty in health care is seeing this type of innovation. It means being able to practice at distances and do a better job.” —Jennifer Hanawald

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Pilot Program To Mobilize Obese Patients Reduces Staff Injuries, Costs Savings estimated at $233,000 or more annually

unique pilot program designed to improve inhospitall mobilization of patients led to a 43% decrease in hospital-acquired pressure ulcers and a nearly 40% drop in injuries among hospital staff. “It’s really been a remarkable improvement in quality through a reduction in adverse events for both patients and employees,” said lead author Walter J. Pories, MD, an attending surgeon at Vidant Medical Center in Greenville, N.C., where the program was created. The hospital created a specialized 24-person lift team with round-the-clockk availability to transport and mobilize heavier and sicker patients. When the expense of hiring and running the lift team was taken into account, the hospital reported an overall cost savings for the year, estimated to be at least $233,125. The money saved was the result of reduced costs of care for pressure ulcers and the significant decline in employee injuries and associated costs. Dr. Pories presented the study at the 2013 annual meeting of the American Surgical Association. Greenville, located in the eastern part of the state, has a higher prevalence of severely obese patients, and poor and elderly patients, than most areas of the United States. This patient population often is difficult to mobilize and can pose risks to the hospital staff who are responsible for transport. Over the past decade, staff at Vidant Medical Center reported an increasing number of workk related injuries and musculoskeletal disorders, frequently resulting from the manual lifting of patients. Direct and indirect costs associated with employee injuries topped $5 million. “It became apparent that we were losing nurses due to injuries,” Dr. Pories said. The hospital tried several ways to prevent staff injuries, including hiring an on-site ergonomist and installing motorized ceiling lifts. Neither strategy led to a significant drop in injuries related to patient handling. In 2011, the hospital came up with a novel pilot program to target employee injuries. It created a 24-member “lift team” consisting of people from

various fields who were then trained in safe moving and lifting techniques. Lift-team members came from widely varied backgrounds such as personal training and emergency management. The teams worked in roving pairs, assisting the nursing staff with safe turning, mobilization, bed surface and moisture management compliance for patients who weighed more than 200 pounds, had a Braden score of less than or equal to 18 and/or pressure ulcers. Unlike previously reported studies of lift teams, Vidant Medical Center’s lift team provided 24-hour and weekend coverage.

‘The cost of fixing one decubitus ulcer would be in the range of $20,000 to $30,000. If this type of approach can prevent a few decubitus ulcers from developing, then it makes sense that these programs could be cost-effective.’ —Philip Schauer, MD The program was implemented in six pilot units, including cardiovascular intensive care, cardiac intermediate care, medical intensive care, medical intermediate care, surgical intensive care and surgical intermediate care. Program administrators selected the units because of their high incidence of patienthandlingg injuries among employees and/or hospitalacquiredd pressure ulcers. In the first year of the program, outcomes improved for both staff and patients. Patient-handlingg injuries among employees dropped 38.5% from the prior year. At least two of the eight injuries reported would have been avoided had the lift team been involved in the transport of those patients, researchers said. In both

cases, clinical staff did not contact the team to help move these patients. One member of the lift team developed a rotator cuff injury over the study period but it was unclear if the injury resulted from her job. Over the same period, patients developed fewer hospital-acquired pressure ulcers, the incidence of which fell by 43%, from 61 in 2011 to 35 in 2012. Staff at the hospital reported high rates of satisfaction with the program. In surveys conducted at the one-, sixx and 12-month periods, 92%, 95% and 89%, of respondents respectively, said the lift team had a positive effect on their job satisfaction. Philip Schauer, MD, director of the Bariatric and Metabolic Institute at Cleveland Clinic, in Ohio, said lift teams like the one at Vidant Medical Center could provide “tremendous benefit” to patients and hospital staff and reduce health care costs at the same time. “The cost of fixing one decubitus ulcer would be in the range of $20,000 to $30,000. If this type of approach can prevent a few decubitus ulcers from developing, then it makes sense that these programs could be cost-effective,” he said. Dr. Schauer also said that the project needs more testing and additional information on things like liftteam training and financial implications is required before more institutions adopt similar programs. “This study finally calls attention to a very important, rarely discussed and often ignored problem: the challenge of mobilizing severely obese patients.” According to the fiscal analysis performed by the investigators, the lift team cost about $1.3 million in 2012 and resulted in reduced costs of more than $1.5 million when employee injuries and cost of pressure ulcers were taken into account. Investigators said that their calculations were conservative. The study also showed a high turnover rate among lift-team members. In one year, eight team members left their job, representing a 24% turnover rate. Half were terminated due to substandard performance and half resigned for personal or academic reasons. In an interview, Dr. Pories said turnover stabilized in 2013. He and his colleagues plan to do follow-up studies that will address the financial effects of the program and the causes of hospital-acquiredd pressure ulcers. The program remains in effect in the hospital. “We would now like to cover all units,” Dr. Pories said. —Christina Frangou

MRI Detects Spinal Infections From Contaminated Methylprednisolone

new study shows that magnetic resonance imaging is able to identify patients with fungal spinal or paraspinal infection, even if the patients have no new or worsening symptoms. The patients in the study were at risk for infection because they had received methylprednisolone injections from a contaminated lot prepared at New England Compounding Center, the source of last fall’s multistate outbreak of meningitis. Evaluating patients at a single site in Michigan, the study by Malani and colleagues (JAMA A 2013;309:2465-2472) identified 172 patients who had received

contaminated methylprednisolone and had not sought related medical care. Of these patients, 108 (63%) had a normal MRI, 30 (17%) had an equivocal result and 34 (20%) had an abnormal MRI. The abnormalities included phlegmon, abscess, osteomyelitis or diskitis, and arachnoiditis. Twenty-five of the patients with equivocal findings were rescreened, and two were found abnormal, for a total of 36 patients (21%) with abnormal MRIs. Of those 36, 35 met the Centers for Disease Control and Prevention’s case definition for probable fungal spinal or paraspinal infection. Thirteen of the patients with an

abnormal MRI were asymptomatic: They had no change in back or neck pain, no evidence of radiculopathy and no lowerextremity weakness. The 35 patients with probable infection received antifungal therapy: voriconazole with or without liposomal amphotericin B. Twenty-four patients underwent surgery, and 17 of those became confirmed cases when laboratory evidence of fungal infection was found. Study limitations, according to the authors, include the small numbers of patients and uncertainty as to whether early treatment due to MRI findings will

improve outcomes. It also is not known, they wrote, whether the results can be generalized to all patients who received tainted methylprednisolone, especially those exposed to less heavily contaminated lots. In an accompanying editorial (JAMA A 2013;309:2493-2495), Thompson and colleagues wrote, “Malani et al have demonstrated the possibility of largely asymptomatic fungal infection among patients previously exposed to injection with contaminated lots of methylprednisolone.” —George Ochoa

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Analysis Finds Room for Improvement In Peripheral Nerve Blocks

nee surgery patients who received a peripheral nerve block had better initial postoperative pain control than patients who did not receive regional anesthesia. But after discharge, block patients reported worse pain control and had a higher incidence of postoperative nausea than those who did not receive the procedure. The findings point to room for improvement in successfully controlling postsurgical pain with oral analgesics once patients leave the hospital, according to the researchers, who presented their results at the 2013 annual meeting of the Society for Ambulatory Anesthesia (SAMBA; abstract 55). “There is a significant difference between how well patients do in the PACU [postanesthesia care unit] and how well they do after they go home,” explained Lucy Everett, MD, chief of pediatric anesthesia at Massachusetts

General Hospital, in Boston, who led the research. “They may do well in the PACU, but their pain may be poorly controlled when they go home. That suggests that we’re not doing a great job managing the transition to oral medications.” These findings are the latest to emerge from SAMBA’s clinical outcomes registry (SCOR), which was created in 2010 to identify nationwide trends specific to ambulatory anesthesia (see Anesthesiology News, November 2012, page 22). To assess postoperative pain outcomes with peripheral nerve blocks, Dr. Everett and her colleagues identified common procedures with a high incidence of postoperative pain, including knee, shoulder and breast surgeries. They then analyzed pain control based on use of additional pain medication in the PACU and surveying patients on how often their pain

was controlled after discharge. Patients who had undergone knee surgery were the largest group, comprising 1,744 patients. Of those, fewer than one in four (24%) required additional pain medication in the PACU compared with nearly half of those who had received general anesthesia alone (47%). After discharge, however, only 61% of block patients reported that their pain was “always well controlled,” compared with 80% who did not have a nerve block. Block patients also reported nausea nearly three times as often as the other knee surgery patients (11.1% vs. 4.5%). The researchers suggest that this may have been due to poorly controlled pain and an initial need for more opioid pain medications. Of the 883 patients who underwent shoulder surgery with a peripheral nerve block, 21% required additional pain medication in the PACU, about

half the proportion of those who did not receive regional anesthesia (40%; P<0.0001). They were also less likely to require antiemetic medication in the PACU—10% versus 17% (P=0.01). Unlike knee surgery patients, there was no significant difference in pain after discharge, and they were half as likely to report post-discharge nausea—7% versus 14% (P=0.01). A low percentage of women undergoing breast procedures—lumpectomies, mastectomies and quadrantectomies, but not biopsies—received peripheral nerve blocks (41 of 1,418). Those who did showed a relatively high incidence of pain in the PACU, but after discharge 82% reported that their pain was always well controlled. Perhaps the most revealing finding of this SCOR analysis, however, was not differences between patients undergoing the same procedures with different anesthesia, but between patients undergoing the same procedures at different centers, Dr. Everett noted. In knee surgeries, for example, the requirement for additional pain medication ranged from 16% to 66% see SCOR page 29

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CL IN ICA L A N E STH E SIOL OG Y

MAC for MIP: Despite Minimal Invasiveness, Challenges Abound New York—Monitored anesthesia care (MAC) may not be the best approach in patients undergoing minimally invasive parathyroidectomy, according to a recent study linking the anesthetic method to complications and an increased use of opioids during surgery. The study, performed by a team of researchers from Yale University School of Medicine, in New Haven, Conn., was based on a retrospective review of consecutive parathyroidectomy procedures performed over a two-year period. The investigators noted that although nerve blocks under MAC have been used in recent years during limited unilateral incision parathyroidectomy, data regarding the safety and efficacy of the technique in this setting are few. “Parathyroidectomy performed through a minimally invasive approach [MIP] may significantly shorten the operating room time or decrease the patient’s exposure to an unnecessary general anesthesia, when done under the proper circumstances,” said Susan Dabu-Bondoc, MD, assistant professor of anesthesiology at Yale, who presented the findings at the 2012 PostGraduate Assembly in Anesthesiolog y (abstract P-9166). “However, MIP may not necessarily decrease the patient’s opioid requirements despite the use of local anesthetic or cervical block during the surgical procedure. The amount of opioids that these patients require may place them under a significant amount of risk. Several anesthetic challenges involving the performance of MIPs under MAC have been identified, and were seemingly not uncommon.” In their analysis of the electronic records of 62 patients who underwent MIP (group 1) and 36 patients who underwent conventional parathyroidectomy procedures (group 2) performed by the same surgeons, patients who had MIP under MAC had shorter surgeries than those who had general endotracheal anesthesia (53 vs. 80.5 minutes, respectively; P=0.004). However, perioperative opioid consumption did not differ significantly between the two groups. Conversion from MAC to general endotracheal anesthesia occurred in 10.7% of the patients in the MIP

group as a result of complications such as obstructive apnea, hypoxia, tracheal perforation, persistent or worsening patient anxiety despite increased sedation, post-emergence reintubation, extended surgical exploration and difficult surgical anatomy.

27). The use of MAC, she said, should depend on the patient’s airway anatomy, including no history of significant snoring or sleep apnea; the patient’s history of anxiety (significant or extreme anxiety are contraindicated); the surgeon’s Dr. Dabu-Bondoc told Anesthesiology skill level; and the nature of the surgiNews that her group’s findings merely cal procedure. The size of the lesion and confirmed what the anesthesiologists the patient’s history of prior surgery and at the hospital have observed clinically. receipt of nerve blocks, as well as obeThey developed guidelines for patient sity and other patient-related factors selection for MAC in the setting of also are important. MIP based on the results (Table, page see MAC page 27

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(two of 23) versus 0.7% (two of 293), respectively (P=0.028). Richard Dutton, MD, executive the institution between May 2011 and February 2012. All of the patients had director of the Anesthesia Quality been covered perioperatively with a Institute, in Park Ridge, Ill., said the results should prompt the Centers for forced–warm air blanket. Despite active warming, Dr. Bron- Medicare & Medicaid Services (CMS) heim’s team found 7.2% of patients to revise its Physician Quality Report(23 of 316) experienced postoperative ing System (PQRS; formerly the Phyhypothermia. These patients were sig- sician Quality Reporting Initiative) nificantly more likely to die within 30 hypothermia quality measure. days of surgery than patients whose The current hypothermia quality meatemperature remained normal: 8.7% sure from CMS specifies that only one of CONTINUED FROM PAGE 1

Why Temperature Matters Clinical trials have shown that hypothermia increases morbidity, including: • Adverse myocardial outcomes • Increased surgical wound infection risk • Increased blood loss and transfusion requirements • Prolonged recovery and length of stay • Coagulopathy

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two conditions must be met in surgical patients receiving more than one hour of general anesthesia: normothermia maintenance during the perioperative period or simply covering the patient with a forced-air warming blanket. “Documented forced-air warming is a process measure, not an outcome measure,” said Dr. Dutton, who was not involved in the study. “As this study shows, some patients still get cold despite active forced-air warming. In these individuals, we need to go beyond forced-air warming blankets and use other warming approaches.” Dr. Dutton, who also is a member of the American Society of Anesthesiologists’ Committee on Performance and Outcomes Measurement (CPOM), noted that the current PQRS criteria were based on criteria submitted by CPOM in 2009 and represented “the best compromise between the known science and the ability to measure performance.” “With limited knowledge of the exact link between temperature and outcome, the criteria specified a performance threshold as well as the ability to meet the measure through good faith efforts to support normothermia,” he explained. However, in light of evidence that has emerged since then that has shown that the potential harms of hypothermia are more significant than previously thought (sidebar), CPOM has submitted a new proposal asking that the measure include only actual hypothermia prevention. “We know that our proposed definition, leaving out the process measure, may lower the rate of successful performance, but in the long term we think it will increase the quality of care,” Dr. Dutton said. Findings Help Identify At-Risk Patients The study helps identify thoracic surgery patients most at risk for hypothermia, said Dr. Bronheim, who presented his team’s findings at the 2013

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CLINICAL ANESTHESI OLOGY annual meeting of the Society of Cardiovascular Anesthesiologists (abstract 96). A preliminary analysis that his team conducted showed lower body weight, shorter height and administration of lower amounts of crystalloids were independently associated with hypothermia (P<0.05 for all). He said his team hopes to isolate the most significant risk factors with further research. They also will be examining whether hypothermia is itself a risk factor for morbidity and mortality or whether it reflects an underlying condition that places patients at risk— something the current study was not designed to discern. “If we find that hypothermia is indeed a direct risk factor for mortality, we would have to study whether other warming techniques might improve outcomes,” Dr. Bronheim said in an interview.

MAC

Should Outcome Measures Be Absolute? While Dr. Dutton argued for a revision of the criteria for the hypothermia quality measure, Dr. Bronheim said a hospital’s rate of hypothermia should be compared with that of other centers. “Unlike wrong-sided surgery, for example, hypothermia is not a ‘never’ phenomenon,” Dr. Bronheim said. “I think that rather than looking at absolute rates of hypothermia, they need to be considered relative to other centers. We need a database, like the Society of Thoracic Surgeons has, where we can enter our patients’ risk factors and our hypothermia rates and see how we’re doing compared to other centers. That’s how our outcomes should be measured.” —David Wild

CONTINUED FROM PAGE 25

Given the small population size of the study, Dr. Dabu-Bondoc and her team acknowledged that larger, controlled trials are needed to “determine the definitive clinical applications of these findings.” However, others in the field agreed that the study results are worthy of note—and further exploration. “This study reminds us that anytime a new surgical approach is developed, anesthesiologists can evaluate new anesthetic regimens that best meet the needs of the surgeon and the patient,” said Alex Macario, MD, professor of anesthesia at Stanford University School of Medicine, in Stanford, Calif. “It would be interesting to ask the authors why the operative time was

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reduced with MAC, as it is unusual to see the type of anesthesia affect incision close time,” continued Dr. Macario, a member of the editorial board of Anesthesiology News. “The conversion rate to general anesthesia of one out of 10 patients is an issue, as intubating a patient while surgery is ongoing is typically something most anesthesiologists aim to avoid especially when the surgery is in the head and neck area.” The researchers said they plan a larger study using their MAC approach to see if any of their findings—such as the effect on incision close time—are generalizable.

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Table. Demographic and Clinical Variables of Patients MIP (MAC) Group (n=62)

CPP (GETA) Group (n=36)

P Value

Age

59.5 (53-67)

62 (51-69.5)

0.73

Body mass index

26.9 (24.2-30.9)

27.9 (24.8-33.0)

0.66

Sex (M/F)

16/46

8/28

0.81

OR time

84.5 min (71-98)

120 min (93-144.5)

<0.001

Operating time, min

53 (46-74)

80.5 (55.5-103.5)

0.004

20 (15-25)

0.05

OR opioids, morphine 11.5 (0.4-3.0) equivalents in mg

Continuous variables summarized by median (interquartile range) GETA, general g endotracheal anesthes anesthesia; sia;; MAC, monitored anesthesiaa care; MIP, minimallyy invasive pparathyroidectomy arathyroidectomy y y

Two sizes

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C LIN I C A L A N ES THES IO LO G Y

Fair AAA Repair: Fixing Gender Inequality for Women

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Miami Beach, Fla.â&#x20AC;&#x201D;One size does not fit all when it comes to choosing an appropriate candidate for repair of aortic aneurysms in the abdomen, a new study has found. Among the results: Using the same absolute aorta diameter cutoff for men and women might place women at a disadvantage and foster worse outcomes by delaying their surgery relative to men.

â&#x20AC;&#x153;At the time of surgery, women might actually have proportionally greater dilation and this might lead to their worse outcome,â&#x20AC;? said Bilal Mahmood, a research assistant in the Department of Anesthesia, Critical Care and Pain Medicine at Beth Israel Deaconess Medical Center, in Boston, who helped conduct the study. Determination of appropriateness of surgery

based on a typical aortic cutoff size of 5.5 cm for both men and women, he said, does not take into account patient sex, body surface area or progression of abdominal aortic aneurysm (AAA). Mr. Mahmood and his colleagues identified a potential solution. â&#x20AC;&#x153;Using a body surface area approach would mean earlier repair and better outcomeâ&#x20AC;? for women, he told attendees at

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the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists. â&#x20AC;&#x153;Women generally do have a smaller body surface area â&#x20AC;Ś which might lead to a better outcome.â&#x20AC;? To find out more, the Boston researchers, led by Robina Matyal, MD, retrospectively assessed 4,193 AAA repairs performed from 2003 to 2011 by the Vascular Surgery Group of New England. The investigators calculated aortic size index (ASI) based on aortic diameter and body surface area for each patient. In all, 1,920 patients (46%) underwent open repair and 2,273 (54%) received endovascular repairs. Women comprised 25% of the open surgery group and 20% of the endovascular repair group. â&#x20AC;&#x153;Results showed that at the time of surgery, women were significantly older and had larger ASI than men in both open and endovascular repair groups,â&#x20AC;? Mr. Mahmood said. In the open repair patients, mean ASI in women was 3.43 versus 3.22 cm/kg/m2 in men and mean age was 72.7 versus 70.1 years. In the endovascular surgery group, mean ASI again was higher in women, 3.23 versus 2.89 cm/kg/m2 and mean age was 75.8 versus 73.3 years. All these differences were statistically significant (P<0.001). â&#x20AC;&#x153;Women did generally have higher mortality and worse outcome,â&#x20AC;? Mr. Mahmood said. They compared women who underwent surgery with a lower or greater ASI than the mean value for men at time of open AAA repair (3.22 cm/kg/m2). The group of women with a mean ASI equal to or greater than this cutoff again was significantly older than men, 74.5 versus 69.7 years (P<0.001). This group also experienced a higher incidence of aneurysm rupture, 18% versus 4.5% (P<0.001); renal failure, 18.3% versus 6.2% (P<0.001); respiratory complications, 23.3% versus 12.9% (P=0.006); and leg ischemia, 6.8% versus 2.2% (P=0.03) compared with women with ASIs smaller than 3.22 cm/kg/m2. Women with an ASI value of 3.22 cm/kg/m2 or higher also experienced higher rates of 30-dayy mortality, 13.1% versus 2.8% for women with lower values, and mortality at one year after surgery, 19% versus 4.5% compared with women with lower ASI values. These differences were statistically significant (P<0.001). The higher morbidity and mortality rates among these women suggests

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CL IN ICA L A N E STH E SIOL OG Y Survival of OAR Women by ASI Cutoff 3.2 1.00

SCOR

0.75

0.5 ASI <3.22 ASI ≥3.22

P<0.0001

0.25

0.00 0

Years

Survival of EVAR Women by ASI Cutoff 2.89 1.00

0.75

0.5 ASI <2.89 ASI ≥2.89

P = 0.7095 SE exceeds 10%

0.25

0.00 0

Years

Figure. Long-term survival of women undergoing open (OAR) and endovascular (EVAR) aneurysm repair, based on the mean aortic size index (ASI) of men. delayed surgery and in turn more advanced disease and more comorbidities compared with men undergoing AAA repair, according to the researchers. Similar outcomes were observed among patients undergoing endovascular repair, but the differences in morbidity and mortality rates were not statistically significant (Figure). “Using a body surface area approach to AAA repair might select women at an earlier stage and may improve outcomes,” Mr. Mahmood said. “Typically, gender bias refers to a variety of things,” said session moderator W. Scott Beattie, MD, PhD, the R. Fraser Elliot Chair in cardiac anesthesia at the University Health Network, in Toronto, Canada. “If you’re going to show an independent risk factor like body surface area, you have to exclude other things like age, types of medications they are on and anemia.” The Boston group did conduct a multivariate analysis that included those factors, Mr. Mahmood said, but found that the only significant risk factor was ASI. “But this is just one factor. There could be other factors that lead to worse outcomes for women,” he said. —Damian McNamara

CONTINUED FROM PAGE 24

between centers, and the percentage of patients who reported wellcontrolled pain after discharge ranged from 40% to 82%. Further evaluation of these differences between apparently similar patient and procedure populations may reveal reasons for the different results. The ability to learn about this difference is the core value of SCOR, Dr. Everett said.

“The overall design and intent of the registry is to give practices and individuals their own results and show them where they would get the most benefit from practice improvement,” Dr. Everett said. “If they can narrow down to a subset of patients and procedures where there is room for improvement, then they can design a new care process for those patients.” Registries like SCOR may represent a new way of studying medical outcomes, said Thomas Cutter, MD,

professor of anesthesia and critical care at the University of Chicago, and a past president of SAMBA. “While randomized controlled studies have been considered the gold standard in medical research, they cannot tell us how a given drug or procedure will perform under real-world conditions,” he explained. “That is the value of registries like SCOR. They give you a sense of best practice and how your practice compares to others.” —Keely Savoie

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Growth in Heart Devices Exposes Gaps In Guidance for Surgery Patients New York—More than 3 million Americans already rely on pacemakers or implantable cardioverter defibrillators (ICDs) to keep their hearts beating properly, but current guidelines differ with regard to the management of elective surgery in this population.

Managing patients with cardiovascular implantable electronic devices (CIEDs) will be a major challenge facing anesthesiologists in the years ahead as increasing numbers of patients present with the technology, according to Marc A. Rozner, PhD, MD, professor

of anesthesiology and perioperative medicine and cardiology at the University of Texas MD Anderson Cancer Center, in Houston (Table). Speaking at the 2012 annual PostGraduate Assembly in Anesthesiology, Dr. Rozner, an expert on CIEDs,

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noted that the volume of devices on the market—including more than 2,500 pacemaker designs—and various technical issues (e.g., asymptomatic patients can have nonfunctioning devices) have contributed to ongoing confusion within the field as to how to best manage patients who are fitted with the technologies. “At my institution, at least 5%, and as many as 15% [of patients with CIEDs] have problems with the device when they come in that are unknown to them and unknown to the people taking care of them,” Dr. Rozner told attendees at the meeting. “Many of them may not have been seen [by their cardiologists] for a long time. So if all you get is that little prescription pad that says, ‘The device is cleared for surgery and you can put a magnet on it,’ that’s probably not adequate.” According to Dr. Rozner, anesthesiologists can “do harm” to patients with CIEDs even if they follow current guidelines for their management. For example, he said that preoperative device “interrogations”—when the unit is checked for proper functioning and its data on heart rhythm assessed— must be performed no more than one month presurgery. But current guidelines from the American Society of Anesthesiologists (ASA) and the Heart Rhythm Society (HRS) suggest that these evaluations can be done anywhere from three to six months before surgery. All preoperative interrogations should address why the device was placed, how often it is used to pace or shock a patient into normal rhythm, when it was placed and when it was last checked, he told the audience. “Bad outcomes are prevented by preoperative interrogation, [even though] it’s economically inconvenient and it’s inconvenient for the patients,” he added. What’s more, Dr. Rozner said that different devices respond differently to magnet placement. Thus, he strongly advised that anesthesiologists learn the specific expected magnet response of a patient’s device and take other steps to limit risk. These steps include checking generators before and after every case, taking proper Bovie pad precautions in the operating room and regularly checking the patient’s pulse during surgical procedures to ensure that the device is working properly and is not

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CLINICAL ANESTHESI OLOGY Table. Essentials of Perioperative Pacemaker Monitoring for the Anesthesiologist

in recent years. For example, in the past for cases involving patients’ ICDs, anesthesiologists could simply ask representatives of the device manufacECG monitoring of the patient must turer to interrogate and switch devices include the ability to detect paceoff before surgery, then reinterrogate maker discharges (consider disabling “artifact filter”). them and switch them back on after a procedure. Perfused (peripheral) pulse must be HRS guidelines now recommend monitored with a waveform display. that the surgical team obtain a written The pacing rate might need to be prescription from the electrophysioloincreased due to an increased oxygen gist who inserted the ICD before surdemand. gery. And unfortunately, Dr. Barash Biventricular and hypertrophic said, some electrophysiologists are obstructive cardiomyopathy patients unwilling to write these prescriptions probably need beat-to-beat cardiac unless they are managing the cases output monitoring. directly at their hospital. Appropriate equipment must be on “The anesthesiologist in practice just hand to provide backup pacing and/or wants to know the quickest and most defibrillation. efficient way to manage these patients,” ECG, electrocardiogram said Dr. Barash, a member of the editoSource: Sou ce Marc a c A. Rozner, o e , PhD,, MD rial board of Anesthesiology News. “The ASA guidelines are a good starting point, but [all] institutions need to go shocking the patient unnecessarily. Cardiac anesthesiologist Paul G. through the difficult process of setting Barash, MD, professor of anesthesiol- up their own protocol [to mitigate risk], ogy at Yale University School of Med- and that takes time. And, with all the icine, in New Haven, Conn., said various stakeholders involved, the anesissues regarding the management of thesiologist can’t fight that battle alone.” anesthesia in patients with pacemakers and ICDs have become more acute —Brian Dunleavy

Bupivacaine Linked To Tendon Damage in Rats

he local anesthetic bupivacaine has shown toxicity to rat tendons in vitro and in vivo, a finding that could have important clinical implications if it is confirmed in humans, Austrian researchers have found. In the in vitro portion of the study (Am J Sports Med d May 9, 2013), bupivacaine severely affected the viability of rat tendon-derived cells grown in culture. The toxic effects were related to drug concentration and time, with viability reduced by 75% when the maximum concentration of 0.5% was applied for 30 minutes. The toxic effect was attenuated by addition of the reactive oxygen species (ROS) scavenger N N-acetyl-LSM CAP-cysteine and reduction of extracellular calcium—suggesting the toxicity is ROS-mediated and dependent on extracellular calcium concentration, according to the researchers. In an email interview, Herbert Tempfer, PhD, of the Institute of Tendon and Bone Regeneration at Paracelsus Medical University, in Salzburg, who led the study, said the antibiotics quinolones and fluoroquinolones are known from published studies to exert toxic effects on tendon cells through ROS signaling. To see the clinical effects of the local anesthetic, Dr. Tempfer’s group then injected 18 Lewis rats with 100 mcL of 0.5% bupivacaine around the Achilles tendon of the rodents’ right legs. The rats were sacrificed at one and four weeks after the injections, and the researchers performed biomechanical testing at both time points. They found that maximum tensile load of the tendons was reduced by 17.6% after the first week but was completely restored at week 4, suggesting that impairment of tensile function is transient. Injections of bupivacaine in live rats caused cells in the tendon tissue to die, and produced a transient increase of pro-matrix metalloproteinase-9, which is known to be induced by ROS. “Taken together, a similar effect in humans would not be surprising but needs to be shown,” Dr. Tempfer said. “If high-quality studies show similar effects in humans, one may suggest not to fully load affected tendons within a few days after injection.” —George Ochoa

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P A IN M E D I C I NE

Small Fiber Neuropathy Hints at Big Effect on Function Miami Beach, Fla.â&#x20AC;&#x201D;The more peripheral neuropathic pain a patient experiences, the greater the impairment in functioning, sleep and emotional well-being, according to new research. Although this may seem intuitive, few studies reveal just how significant these effects can be for someone with small fiber neuropathy, according to the investigators of the current research. Pfizer researchers Alesia Sadosky, PhD, Bruce Parsons, MD, and their colleagues assessed 100 people with peripheral neuropathy with small fiber involvement from general practitioner and specialty treatment settings in the United States. â&#x20AC;&#x153;Increased pain interference [with activities of daily living (ADL)] and increased sleep interference are problems associated with increased severity of pain scores,â&#x20AC;? said Dr. Sadoskyy in a presentation at the 2012 fall meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA). Using validated measures, participants reported a high number of comorbidities, increased anxiety and depression, and overall deficits in sleep and function. These factors correlated, some significantly, with the severity of small fiber peripheral neuropathy, according to the findings (abstract 13). The mean pain score was 5.2 on the Brief Pain Inventory-Short Form (BPI-SF) average pain severity score (scale, 0-10; 0=no pain, 10=worst possible pain), for example. â&#x20AC;&#x153;We grouped patients by mild, moderate or severe pain,â&#x20AC;? said Dr. Sadosky, y director of the Global Market Access/Primary Care Business Unit at Pfizer Inc., in New York City. â&#x20AC;&#x153;We saw 76% [of participants] had either moderate or severe pain,â&#x20AC;? Dr. Parsons, senior medical director at Pfizer, said at the ASRA meeting. Importantly, those with greater pain severity reported significantly more interference with ADL. Again on a scale of 0 to 10, those with mild pain reported a mean 2.1 on the BPISF Pain Interference Index compared with 5.0 for those with moderate pain and 7.1 for those with severe pain (P<0.0001). A majority of participants had one or more comorbidities, based on patient report and a six-month review of their medical records. Overall, patients had a mean of 3.3 comorbidities. Those with mild pain had the lowest mean number of comorbidities (2.2) followed by 3.5 for the moderate

pain group and 3.7 among those with severe pain. â&#x20AC;&#x153;If you have small fiber neuropathy, you are unlikely to have it in isolation,â&#x20AC;? Dr. Parsons said. Sleep disturbance/insomnia, anxiety and depressive symptoms were the most common comorbidities in the study. A majority of participants (84%) were prescribed at least one medication to treat their neuropathic pain,

including 20% who were prescribed three or more. Slightly more than half were prescribed an antiepileptic and just under half were given an opioid. About one-fourth were prescribed strong short-actingg opioids and 20% were prescribed a long-actingg opioid. â&#x20AC;&#x153;One of the striking things we saw were people not being treated optimally,â&#x20AC;? Dr. Parsons said. â&#x20AC;&#x153;If you want

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to treat optimally, start with antiepileptics, tricyclic antidepressants, etc., and only go to opioids for people who require them. Clearly, this is not the way these people are being treated.â&#x20AC;? James Eisenach, MD, editor of Anesthesiology and moderator of the poster session at which the data were presented, noted the drug classes suggested by Drs. Sadosky and

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J U LY 2 0 1 3

AnesthesiologyNews.com I 33

PA IN M E D ICIN E Parsons included agents made by their employer. He also asked how participants were diagnosed. Some patients completed 10- to 15-minute testing for hyperalgesia and allodynia in their physicianâ&#x20AC;&#x2122;s office and/or had a decreased density of small fibers on a punch biopsy, Dr. Parsons said. However, most patients were diagnosed clinically, he added. Dr. Eisenach is professor of obstetrical and gynecological anesthesiology at Wake Forest Baptist Health, in Winston-Salem, N.C.

On Off

Participants had a mean age of 63.5 years, 53% were women and 16% were gainfully employed. They each completed a one-time questionnaire and other assessments. Researchers also developed a case report form based on a six-month chart review for the treating physician to complete. â&#x20AC;&#x153;There is a significant increase overall in health care spending related to small fiber neuropathy,â&#x20AC;? Dr. Sadoskyy said. Mean annualized costs related to small fiber neuropathy were $21,514 and

increased significantly as pain severity increased. The mean health state utility, used to calculate cost-effectiveness of health interventions, was 0.59 on the EQQ 5D (scale of â&#x20AC;&#x201C;0.11 to 1, 1=perfect = health). The finding decreased as pain severity increased from 0.80 for mild pain to 0.61 for moderate pain to 0.42 for those with severe pain. The difference by pain severity was statistically significant (P<0.0001). The mean Medical Outcomes Study (MOS) Sleep Disturbance score was

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Visit www.aboutULTIVA.com to see where Remi could work for you. Please see Indications and Important Risk Information below and accompanying brief summary of Prescribing Information on next page for all precautions, warnings, contraindications, and adverse events.

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Ăľ NDH LH NJO 'BJMVSF UP BEFRVBUFMZ DMFBS UIF *7 UVCJOH UP SFNPWF SFTJEVBM 6-5*7" IBT CFFO BTTPDJBUFE XJUI UIF BQQFBSBODF PG SFTQJSBUPSZ EFQSFTTJPO BQOFB BOE NVTDMF SJHJEJUZ VQPO UIF BENJOJTUSBUJPO PG BEEJUJPOBM n VJET PS NFEJDBUJPOT UISPVHI UIF TBNF *7 UVCJOH

%VF UP UIF QSFTFODF PG HMZDJOF JO UIF GPSNVMBUJPO ULTIVA is contraindicated for FQJEVSBM PS JOUSBUIFDBM BENJOJTUSBUJPO 6-5*7" JT BMTP DPOUSBJOEJDBUFE JO QBUJFOUT XJUI LOPXO IZQFSTFOTJUJWJUZ UP GFOUBOZM BOBMPHT 6-5*7" 4)06-% #& 64&% */ 5)& $"3&'6--: .0/*503&% 4&55*/( #: 41&$*'*$"--: 53"*/&% 1&340/4 /05 */70-7&% */ 5)& 463(*$"- 03 %*"(/045*$ 130$&%63& 09:(&/ 4"563"5*0/ *4 50 #& $0/5*/6064-: .0/*503&% 3&464$*5"5*7& "/% */56#"5*0/ &26*1.&/5 09:(&/ "/% "/ 01*0*% "/5"(0/*45 .645 #& 3&"%*-: "7"*-"#-& 3FNJGFOUBOJM JT DPNNPOMZ SFGFSSFE UP BT 3FNJ CZ BOFTUIFTJB QSPWJEFST References: 1. Data on ďŹ le. Canonsburg, PA: Mylan Institutional; 2012. 2. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.

47.5 and mean MOS Sleep Problems Index score was 45.1 (each on a scale of 0-100). Again, the scores were significantly higherâ&#x20AC;&#x201D;indicating poorer sleepâ&#x20AC;&#x201D;as pain severity increased (P<0.0001). Mean anxiety score was 8.3 and mean depression score was 7.3 (on a 0-21 scale). Patients with higher pain severity had significantly higher anxiety (P=0.0005) and depression (P=0.0002). â&#x20AC;&#x201D;Damian McNamara

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Myelopathy, Spinal Cord Injury Seen Boosting SSI Risk Mont Tremblant, Quebec— Patients who have myelopathy or a spinal cord injury are much more likely to develop a surgical site infection (SSI), according to an administrative database study of posterior cervical spine surgery. Patients who are aged 50 years or older also have a small but significantly elevated risk for an SSI.

ULTIVA® for Injection

The researchers extracted data from the Nationwide Inpatient Sample on inpatients who underwent surgery between 2000 and 2009, and compared groups with radiculopathy with or without myelopathy, and traumatic cervical injury with or without a neurologic injury. The team presented the results at the Canadian Spine Society’s 2013 annual meeting.

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits

“The thought is that when looking at rates of concurrent neurologic dysfunction in such a large cohort, the effect is probably real rather than confounding,” said lead investigator Ravi Ghag, MD, an orthopedics resident at the University of British Columbia, in Vancouver. Dr. Ghagg and his colleagues identified 1,762,277 patients, of whom 1,389,763 had radiculopathy and

and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous ﬂuids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a speciﬁc antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045

52,979 had a traumatic cervical injury. Among the radiculopathy patients, 372,514 (26.8%) had concurrent myelopathy, and 15,034 (28.4%) of the trauma patients had concurrent neurologic injury. Patients with concurrent myelopathy and those with concurrent neurologic injury were significantly older, and more were men, than the other patients in their respective groups (P<0.001 for both). Patients with myelopathy were more likely to be black, Asian or Hispanic. Bivariate analysis revealed that the percentage of SSIs was 0.58% among patients with radiculopathy without myelopathy and 1.35% among those with radiculopathy and myelopathy (P<0.001). Multivariate regression analysis revealed that patients with radiculopathy and myelopathy were about 80% more likely to have an SSI than those without myelopathy (P<0.001). Patients with a traumatic cervical injury and concomitant neurologic injury had 1.33 higher odds of having an SSI than those without a neurologic injury (P=0.07). Fusion of two or three vertebral levels among patients with trauma was protective compared with fusion of four to eight vertebral levels (odds ratio [OR], 0.49; P<0.001). Older patients with radiculopathy had a higher risk for SSI than younger patients (OR, 1.03; P<0.001), whereas female sex was protective against SSI (OR, 0.61; P<0.001). The investigators said using an administrative database resulted in underestimating the rate of complications in all patients. This method also did not allow analysis of factors known to affect the rate of SSIs, such as diabetes, intraoperative irrigation, duration of surgery and other variables. Keith Baldwin, MD, MSPT, MPH, assistant professor of orthopedic surgery at Children’s Hospital of Philadelphia, who was not involved in the study, added that “the follow-up for these databases is generally too short to determine the true rate and cost of infections, and as such the true infection rate is likely higher than reported. But there is no reason to suspect that the data are differentially biased with respect to neurologic damage. As such, their P values are likely to be correct, even if their exact percentages and odds ratios are not.” —Rosemary Frei

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Opioid–Antidepressant Combinations Prominent in Drug Overdose Deaths

f the 22,134 drug overdose deaths involving pharmaceuticals in the United States in 2010, three-fourths involved opioid analgesics, according to an analysis by the Centers for Disease Control and Prevention (CDC). In a research letter published in the Journal of the American Medical Association (2013;309:657-659), Christopher M. Jones, PharmD, a health scientist with the CDC’s Injury Center and two colleagues parsed data from the National Vital Statistics System multiple cause-off death file. The file contains information gleaned from death certificates submitted to the CDC by medical examiners or coroners. They determined that 57.7% (22,134) of the 38,329 drug overdose deaths in the United States in 2010 involved prescription pharmaceuticals. The top drugs that were involved in those overdose deaths included opioid analgesics (75.2%), benzodiazepines (29.4%), antidepressants (17.6%), antiepileptic and antiparkinson drugs (7.8%), and systemic and hematologic drugs (7.2%). Nearly three-fourths (74.3%) of the medication-related deaths were deemed unintentional and 17.1% were suicides. Among the overdose deaths that involved opioids, the most common medications taken concomitantly were benzodiazepines (30.1%), antidepressants (13.4%), and antiepileptic and antiparkinson agents (6.8%). The team also looked at what fraction of overdose deaths involving other medications also involved opioids. They found opioids were implicated in 77.2% of overdose deaths that involved benzodiazepines, 65.5% of deaths in which antiepileptic and antiparkinson drugs also were implicated, 58% of deaths involving antipsychotics and neuroepileptics, and 50% of barbiturate-related deaths. Among central nervous system and psychotherapeutic drugs, opioid analgesics were the drug class with the highest percentage of deaths in which no other drug class was involved: Nearly 30% of opioid analgesic–related deaths involved no other drugs. Benzodiazepines were involved in the smallest proportion of single–drug class deaths, with only 2.7% of benzodiazepinerelated deaths involving no other drugs. “The main take-awayy message from our work is that beyond the opioid

analgesics, mental health medications are commonly involved in overdose deaths,” Dr. Jones said. “That really highlights the importance of screening for mental health or substance abuse disorders when a patient comes to the doctor’s office, especially if the provider is trying to determine whether to

prescribe a drug like an opioid analgesic or a benzodiazepine, which have abuse potential.” He noted that other studies have shown patients with mental health disorders are at increased risk for an overdose death (J ( Clin Psychiatry 2010;71:491-496). They also are more

Enhanced Humbles LapWrap p Positioning Pad

likely to be prescribed higher doses of opioids, and also may be more likely to selff escalate the dose, Dr. Jones said. His team now intends to study the medication combinations that have been involved in drug overdose deaths over time. —Rosemary Frei, MSc

Now even more secure with two-way performance! Anesthesiologist Frank Humbles, M.D. knows the importance of patient positioning. The Enhanced Humbles LapWrap®. • Positions patients arms while allowing easy access for leads and IV’s • Secures patient to OR table • Is dual sided for increased flexibility • Optional extensions can be attached for the extremely obese

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Keep arms securely positioned. Designed to prevent tissue injury. Arms stay where you put them during the procedure.

Adaptable to all size patients. Use the optional extensions to secure the extremely obese.

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For more info or to order call 1-800-467-4944 US Patent No. 8,001,635

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CONTINUED FROM PAGE 1

Genetic Addiction Risk Score In a small pilot study, researchers used the genetic addiction risk score (GARS) to assess the extent to which genes can determine addictive behavior. Following a literature review, they identified six risk alleles and candidate genes that were associated with hypodopaminergic function and addiction: DRD2; SLC6A3 (DAT1); DRD4; 5HTTLLR; MAO-A - and COMT. T Study participants were divided into two ethnically different groups of poly-drugg abusers. The first study group consisted of 16 white men who used psychostimulant substances and the second group was composed of 10 heroin-addicted Chinese men. Risk severity was determined by calculating the prevalence of risk alleles in each group and using an arbitrary severity score based on the percentage of risk alleles and candidate genes. All 26 of the study participants had at least one risk allele at 100%, and 56% of the men in both groups carried the DRD2 A1 allele. Of all the participants, 74% had a moderate to high GARS. However, the groups did not differ significantly in terms of overall severity (67% vs. 81%) in these two distinct populations. A larger GARS study also was conducted with 80 participants from two substance abuse treatment centers: the G&G Holistic Addiction Treatment Center, in North Miami Beach, Fla., and Malibu Beach Recovery Center, in Malibu Beach, Calif. In addition to the original six genes analyzed in the pilot study, another three were added: DRD3, OPRM1 and GABRA3, with 18 alleles for women and 17 alleles for men. Researchers calculated a risk severity code using an algorithm. Researchers found that 86% of participants (n=70; due to poor DNA extraction, The Institute of Advertisement

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‘People are going to pain centers and their physicians are prescribing pain medications but maybe they don’t realize that some patients have genes that predispose them to addiction.’ —Kenneth Blum, PhD

Behavioral Genetics at the University of Colorado, in Boulder, could not provide DNA results for 10 of the original participants), had a moderate to high GARS, similar to the result of the pilot study. The Addiction Severity Index (media version) was implemented to ascertain whether a correlation existed between the subjectivity of the questionnaire and the objectivity of the GARS test. “The final outcome for this evaluation awaits final testing of about 450 people,” Dr. Blum said. “Based on our investigation utilizing nine genes [and alleles], we are consistently finding a moderate to high genetic risk in patients identified with drug addictive behaviors,” Dr. Blum said. “However, most interestingly, there are differences observed among these tested patients in terms of what specific gene polymorphisms are found. This will have great significance in terms of future therapeutic targeting of gene polymorphisms and even medication monitoring.” Comprehensive Analysis Of Reported Drugs Further to establishing patients’ risk for addiction is monitoring their existing use of prescribed and nonprescribed drugs for compliance and potential misuse or abuse. “The conundrum is that doctors do not know if the patients who are coming in to be treated for pain are also addicts,” Dr. Blum said. “They [doctors] can obtain psychosocial information, but how accurate is it? A lot of times, addicts lie.” Using the Comprehensive Analysis of Reported Drugs (CARD), a questionnaire developed by Dominion Diagnostics, researchers evaluated 10,570 patients at substance abuse centers across six states over a two-year period from 2010 to 2011. During the study, 21,140 urine samples (two per participant) were analyzed for compliance with treatment medications and abstention from drugs of abuse. They also tested 1,380 samples from 690 methadonetakingg participants, and 2,744 samples from 1,372 participants taking the addiction treatment Suboxone (buprenorphine and naloxone, Reckitt Benckiser). The researchers found that every reported prescription drug and drug of abuse were present in both the first and last urine sample. Compared with patients on

methadone and Suboxone, fewer of the general treatment population complied with prescribed treatment medication (methadone users, 92%; Suboxone users, 88%; general population, 67%). Furthermore, fewer members of the general population (39%) abstained from drugs of abuse (including but not limited to opioids) than methadone users (51%) and Suboxone users (52%). Dr. Blum said that although patients on methadone and Suboxone have a higher rate of compliance, they still continue to abuse drugs. “In fact, we found that, for example, in the Suboxone group, the drugs of abuse found in the urine utilizing CARD were 47% opiates—surprisingly higher than we expected. So although both methadone and Suboxone have beneficial effects, we have not found the ‘magic bullet’ as yet.” Interactive Voice Response System Based on the premise that long-term opioid users can experience depression, the researchers sought to further quantify this assessment by gauging what they term the “true emotionality” of the patient, using an interactive voice response system. Patients’ responses were recorded on a web server and the affect in speech was analyzed for expressiveness, selff awareness and empathy using validated Gaussian mixture modeling. Results showed that patients on long-term opioids, including methadone and Suboxone, had a “significantly flat affect (P<0.01),” consistent with depression, compared with the general population and the Alcoholics Anonymous community. KB220Z Neuroadaptogen Complex Researchers evaluated the effects of KB220Z—a dopamine transporter (D2) agonist that was developed by Dr. Blum—on the brain’s reward circuitry, in a triple-blind, randomized, placebo-controlled, crossover study. One hour after administration of KB220Z, five heroin addicts with an average abstinence period of 16.9 months were given a functional magnetic resonance imaging test, and 10 psychostimulant drug abusers with an abstinence period of at least nine months underwent a quantitative electroencephalography. Results showed that, compared with placebo, “KB220Z induced a blood oxygenation level–dependent activation of caudate-accumbens dopaminergic

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PA IN M E D ICIN E pathways, reduced the higher dopaminergic activity in the putamen and in 10 subjects, three brain regions of interest were found to be activated from resting state (P<0.05),” according to the study, which suggested a “putative, anti-craving/anti-relapse role for KB220Z by direct or indirect dopaminergic interaction.” Andrea Trescot, MD, a pain management specialist with Orthopaedic Associates of St. Augustine in Florida, said, “I already use a company called ‘Prove’ to test for genetic susceptibility to addiction. The [study] material is very important. The poster actually described four different studies … genotyping pain patients at entry for opioid addiction risk, urine monitoring for compliance, evaluation of depression via computerized, voiceactivated screening and pharmacologic support to increase dopamine sensitivity. This represents the first time, in my knowledge, that genetics have been incorporated into a global treatment algorithm.” Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing and chair of the Department of Psychiatry at Maimonides Medical Center in New York City, said, “It’s clear that [the researchers] are looking to identify a genetic factor related to opioid addiction. The reason to look for a genetic link is if you thought of opioid addiction as a genetic illness, but if you understand it as resulting mainly from exposure to opioids, then my impression of the study is that it doesn’t make much sense to me,” Dr. Kolodnyy said. “With alcohol it’s different: It does make sense to genetically study those who are addicted because most people who drink are not alcoholics. But when it comes to highly addictive drugs, searching for an addiction gene makes less sense because many people with repeated or prolonged exposure to the molecule will get addicted. With highly addictive drugs, it may actually make more sense to study the genes of those who can use without getting addicted. Something you see in the pain community is that they make the mistake of thinking about opioids in the same way they think about alcohol.” In response to Dr. Kolodny’s remarks, Dr. Blum said, “With due respect, while it is correct that high doses of opioids may result in physical addiction, it is not true that opioids and alcohol are different neurobiologically in terms of net dopamine release. To state that ingestion of opioids is not an illness is true, but Dr. Kolodnyy is

missing the real issue concerning addiction per se. According to the American Society of Addiction Medicine, addiction is indeed a ‘brain disorder of impairment of the reward circuitry.’ It does make sense to evoke stratification of ‘genetic risk’ for incoming pain patients because this can result in a gateway to further addictive behaviors including other drugs.” Dr. Kolodny added, “Some drugs are inherently more addictive than other drugs and that’s my point—that

when it comes to highly addictive drugs, it may make more sense to look at the genes of people who can use highly addicted drugs without getting addicted and see what’s different about their genes. So I’m not saying there’s no genetic role: I’m saying that we need to think about alcohol and opioids differently, and opioids are highly addictive drugs, so to look for an addictive gene doesn’t make much sense to me.” —Maureen Sullivan

Dr. Blum is chairman of the board and chief scientific officer of LifeGen Inc, the company that holds exclusive licenses for his patents for KB220Z. Dr. Blum is the inventor of GARS and is working on commercialization with Dominion Diagnostics LLC and LifeGen Inc. Dr. Blum is a member of the Scientific Advisory Board at Dominion Diagnostics. Dr. Kolodny reported no conflicts of interest. Dr. Trescot is medical director of Pinnacle Labs. She is also on the speakers bureau of Eli Lilly, Pfizer and Janssen.

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Oral Ketoprofen Trumps Other NSAIDs in Meta-Analysis Miami Beach, Fla.—Oral ketoprofen offers more significant benefits than diclofenac or ibuprofen for relief of pain associated with arthritis, ankylosing spondylitis, and lower back or shoulder conditions, according to a meta-analysis. Noting a lack of randomized, placebo-controlled studies that directly compare multiple nonsteroidal

anti-inflammatory drugs (NSAIDs), Piercarlo Sarzi-Puttini, MD, Fabiola Atzeni, MD, and their colleagues conducted a systematic review of the literature. Their aim was to identify and combine research findings and provide clinicians with practical guidance on which of the most commonly used NSAIDs is superior. “We believe that it is very important

to have an anchor NSAID for treating rheumatic and traumatic pain,” said Dr. Atzeni, a rheumatologist at L. Sacco University Hospital in Milan. The researchers compared the analgesic efficacy of the most frequently prescribed NSAIDs for pain: oral ketoprofen 50 to 200 mg per day, ibuprofen 600 to 1,800 mg per day and diclofenac 75 to 150 mg per day. They identified

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13 relevant randomized controlled trials published up to June 2011. These studies included 898 patients with similar baseline demographics and disease characteristics who were prescribed these agents for several mild, moderate or severe pain. The review included eight ketoprofen versus ibuprofen trials and five ketoprofen versus diclofenac comparisons. “The effect of therapeutic doses of ketoprofen [was] strongly greater than the effect of therapeutic doses of ibuprofen or diclofenac,” the authors wrote. The difference in analgesic efficacy between ketoprofen and ibuprofen or diclofenac was statistically significant (odds ratio, 0.459; 95% confidence interval, 0.33-0.58; P=0.00). In other words, a standard deviation point estimates plot demonstrated the positive efficacy of ketoprofen compared with ibuprofen or diclofenac with a line statistically above the “no difference” point. The study was presented at the 2012 fall meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 21). Ketoprofen was superior to ibuprofen or diclofenac in all of the randomized controlled trials in the meta-analysis. The agent’s superiority was statistically significant in nine of these trials (P<0.05). “Systematic reviews including placebo-controlled studies can only conclude that the analgesics work,” said Luis Enrique Chaparro, MD, an anesthesiologist and a pain medicine specialist in Medellin, Colombia. “However, clinicians already have many effective drugs in the market, and now they want to know which analgesic is the most effective. For this question, head-to-head comparisons are the answer, which is the focus of this review.” Dr. Chaparro added, “It is interesting that a systematic review … of these analgesics shows no difference for efficacy based on the number [of patients] needed to treat. “Even more interesting would be to compare the safety profile—especially assessment of cardiac and renal events— of the aforementioned drugs in a headto-head fashion,” Dr. Chaparro said. “Based on systematic reviews of observational studies, diclofenac has shown an increased rate of cardiac events.” —Damian McNamara The study was supported by an unrestricted grant from Dompé SpA, a maker of ketoprofen in Italy.

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Intradiskal Biacuplasty for Low Back Pain Increases Function, Decreases Chronic Pain Miami Beach, Fla.—A minimally invasive procedure known as intradiskal biacuplasty (IDB), used on patients with diskogenic pain, significantly improves function and decreases pain and disability six months later, according to a recent study. The procedure involves placing electrodes onto a patient’s lower back to deliver radiofrequency (RF) energy. “There were no adverse events and there were even no reports of postprocedural flare-ups,” said Leonardo Kapural, MD, PhD, professor of anesthesiology and clinical director of the Chronic Pain Center at Wake Forest University Health Sciences Center, in Winston-Salem, N.C. He presented the data at the 2012 fall meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA; abstract 26). Dr. Kapural and his colleagues randomized patients to two groups: Twentyy nine patients completed followw up in the intervention group and another 30 completed follow-up after a sham procedure. Participants in the sham control group were hooked up to electrodes, with simulated sound effects to mimic the real procedure, placed outside the disk but no RD energy was transmitted. All study participants had a history of six months or more of chronic low back pain (LBP). To perform IDB, the researchers placed two cooled RF electrodes on the posterolateral aspect of the intervertebral annulus fibrous in a bipolar manner. The aim was to ablate the neo-innervated area. For the sham procedure, the probes were inserted into the subcutaneous tissue. This was the first randomized, shamcontrolled, double-blind assessment of this therapy for patients with chronic, diskogenic LBP, Dr. Kapural said. He added that the findings supported the positive benefits of IDB suggested by previous researchers who performed small, uncontrolled case series (Int J Med Scii 2010;8:1-8; Pain Medd 2008;9:60-67). “Our results strongly support the notion that treatment effects of IDB are non-placebo effects,” Dr. Kapurall said. Statistically significant differences emerged in the IDB group for the study’s primary outcome—improvement of physical function in the Short Form Health Survey (SF-36) subscale compared with the sham group (P=0.029). The intervention group also experienced statistically significant decreases in pain (P=0.006) and disability (P=0.0370).

Dr. Kapural said the study was relevant because “low back pain affects about 80% of Americans at some point in their lives.” Furthermore, diskogenic pain, defined as pain stemming from internal disruption of the intervertebral disks, causes the majority of chronic LBP (Spine 1995;20:1878-1883).

with two disks affected were somewhat less, and we never included patients with three or more disks degenerated on MRI and/or pain during provocative diskography.”

Session moderator James P. Rathmell, MD, professor of anesthesia at Massachusetts General Hospital, in Boston, asked if the study results led to a significant change in people’s lives. “Yes, it does,” Dr. Kapural replied. “Especially in patients with one-level diskogenic pain. Results in patients

—Damian McNamara The study was funded by Baylis Medical. Dr. Kapural receives honoraria from Medtronic and St. Jude Medical and research funding from Bioness, Boston Scientific, Kimberly Clark, NDI, and Nevro. Dr. Rathmell reported no relevant financial conflicts of interest.

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Robert ert SSouthey eyy

Henry ry Be Beecher er

n tthe Feb. Feb 14, 1 1947 47 issue i e oof Science, cien Heenryy Kn nowles les Beecher cher published ubl ed an a article arti with wit a striikingg ti title: “Anes esthesia’s hes Sec Second d Po Power: r: P Prob iing the Mind.” ind. Beecher eech r had delivered live a talk t on thee subject ject thee previous pr ous Occtob ctober at the cto t Ether Eth Centen Cen nial Ce n Celebration brati in Bosston on n. In n th the article, artic he discussed sed thee re remembered mbe d psyc ychological holo al eexperiences rien s while w le bbreathing athin nitr nitrouss ox oxide de of Humphry ump y Davy D y, Benjamin B jam Pau Paul Bloo Blood, William Wil m James es and a oth others. Near N ar th the end nd of the article, cle, Beecher echer her note h noted, “Age “Agentss tthatt fall fal into to tthe gro group of tthe anes anesthe hetics eti thus etics us h havee ppower wer in addition add on to the their anodyne ano nee effects—a e ects a ppower wer to t reveal, eve to ccontrol, rol, and d to relieve ieve problems proobl o s oof the he m mindd.” In n th the Dece December er 1946 1 6 issue iss of tthe Yale Journal urna off Biology B logy andd Medicine M cine, psychiatrist ych ist Burness B ness E. Moore Mo e ppublished lish “The “Th Contribution Con buti of Anesthesia A sthe to Psyychiatry, chia atryy” which wh hich h originated orrigin nateed aas a talkk at ano another otheer et ether therr centennial celebration in New Haven, Conn., also the previous October. Moore was familiar with Beecher’s talk, and his own article covered some of the same individuals but went into much greater detail on drugs developed in the 20th century to explore what he called anesthesia’s “step-child”: the power “to explore the mental life of the patients.” A Rich Literature Both physicians would probably not be surprised by some developments in this area in our own time. Two researchers at the University of Alabama at Birmingham, Richard Shelton and Cheryl McCullumsmith, are beginning a study of ketamine for possible treatment of severe depression and suicidal urges. A search for articles on PubMed on this topic reveals a rich literature of research. And in a long article, “Awakening,” in the January 2013 issue of The Atlantic, Joshua Lang explored what researchers are learning about the effects of anesthesia on the brain. How will understanding the brain in the anesthetic state help us understand the mind? Many accounts by patients, physicians, researchers and others about their personal psychological reactions to anesthetic drugs have been published since Davy gave us his and those of fellow selff experimenters in England in his 1800 book,

Pe Peter Mark Roget get

Sir Humphrey mphre Davy vy (Portrait rtrait by Thom Thomas Phillip Phillips)

R earc Che Research, Chemical al aand Ph Philosophical, oph l, C Chieffly C Conccerning ning Nitrous trou Oxid Oxide. Davy had ad arrived a ved in C Cliffton, ooutside side Bristol, isto England, ngla , in October tob 1798, 179 too beegin n rresearch arch on n po possible ble medical dica uses ses of gas inhaalattion. He was hired H red by Thomas Th as B Beddoes, doe whose who recentlyy ffounded nde Pneumatic Pne atic Medical Med l Institute In tute brouughtt ttogether ethe three hree goals: oals clinical inic care care, educatio duc on, andd clinical ical and d ba basic rese research. Beddoes edd was wa especially pec y interested in sted in po possiblle trreatments m nts for tub tuberculosis, culo a disease ease becoming com g m moree common mmo in n rapidly r dly industrializing dustr izin Britain. rita Befforee setting ing up in Clifton, ifton Bedd Beddoess ha had alre already begun n iimplementation plem tatio of JJoseph ph Priestley’s estl su suggesstioon a ffew years yea earlier arli that hat gas inhalation inh tion might ight havve m mediical app applications. ation He set up the inst institute, te, h hired dD Davyy, started arted ted advertising verti g fo for patients atien and the wo work bega bbegan. an. After seelf lff experime experimenting erim ntin with h vari various ga gasess and ne nearly earlyy kkillin killing ng h him himself mselff in n th the he process, p cess D proc Davyy announced in a letter to Nicholson’s Journal in April 1799 that humans could safely inhale nitrous oxide. In his book, published in summer 1800, Davy recalled what he felt while under the influence of nitrous oxide, which he tried many times. “Nothing exists but thoughts!” he remarked after one session. “The universe is composed of impressions, ideas, pleasures and pains!” Despite Beddoes’ noble intentions, the Pneumatic Institute quickly became Bristol’s salon of what now would be considered recreational drug use. Many of the port’s young intellectuals came to try this gas they were hearing so much about and often used it alongside the patients. Others, such as publisher Joseph Cottle and author Maria Edgeworth, came to observe the strange effects on participants. Robert Southey, future Poet Laureate of England, declared after an early trial, “during the remainder of the day, [I] imagined that my taste and hearing were more than commonly quick. Certain I am that I felt myself more than usually strong and cheerful.” Later experiments were not so pleasurable for Southey. Other participants included Samuel Taylor Coleridge and such sons of the famous as Thomas Wedgewood, James Watt Jr., and Joseph Priestley Jr. Peter Mark Roget, just out of medical school and still years away from many other achievements—

Oliver ver W Wend Wendell dell H Holmes es Sr Sr.

i udin his eponymous including e nym s th thesaurus— urus— —left eft a lon ng, selffanalytical lytic com comment nt in Dav Davy’s boo book ok. “My ideas ok eas succeeded ded onee another an her with w h ex extrem mee rapidity, r dity thoughts houg s rrushed hed likee a torrent rent through rou my m mind, nd, as if their t r vvelocity city had ad bbeen sud suddenly nly acce celerated ce eeler d by thee burst bu iing of a barrier arrie which whic had bef efore ef ore retained aine them hem in n ttheir ir natural n ral and d eq equable ble cco course, rse,” Roget oget wrote. rote “II cannot not remember mem r th that I exxperienced ienc the least ast ppleasuree fro from thes these sensation nsat ns ns ns.” Many other ther individ diviid iduals als iin the he 19th h ce century ury leftt rrecords ords off th their ps psyychological olog l ex experiences rien under un r anesthesia. sthe . A Among Amo moong them hem was as Oliver iver Wen Wendelll Holmes H lmes Sr.,., ph hysician, cian author utho and nd tthe man who ho in a lletter er too Morton Mort sugg M suggested ed tthe wor word “anesthesia” anes esia” forr tthe he mental men me m state sta produced rod d by ether her inhalation alat . “I once on inhaled inh ed a pretty pret full dose ose of et ether,”,” Holmes H lme wrote, rote “with with the he determination d rmi ion to put on n record, rreco ord at thee earliest eaarlieest mo momen moment nt oof rega rregaining ainin ng ccon consciousness, the thought I should find uppermost in my mind.” But like so many people who experience the secret of the universe, upon reflection they just cannot remember it or the revelation dissolves into silliness. “The one great truth which underlies all human experience,” the great doctor wrote, “flashed upon me in a sudden revelation. A strong sense of turpentine prevails throughout.” Anesthetic Revelations Benjamin Paul Blood was an eccentric author who lived most of his life in the small town of Amsterdam, N.Y. After an experience while under ether anesthesia for a dental procedure, Blood constructed an elaborate philosophy around that Anaesthetic Revelation, as he titled an 1874 pamphlet. Blood expanded his thinking in Pluriverse, published the year after his death in 1919. In that work he wrote, “It was in the year 1860 that there came to me, through necessary use of anaesthetics, a Revelation or insight of the immemorial Mystery which among enlightened peoples still persists as the philosophical secret or problem of the world.” Blood had mailed copies of his original pamphlet to many individuals, including philosopher and psychologist William James, with whom he began a correspondence in 1882. see mystic page 42

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H.G. H .G. G W Wells ll

MYSTIC

Theodore TTh ddore D Dreiser iser

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Blood loo apparent ppa tly t influenced luen d so some th thinking; ing “A A P ralis Mystic Pluralistic My ,” h his final published ublis d work, w , was wa a llongg es essay devoted dev d too the he other o r man. m James Jam himself him f experimented erim ted witth h nitrous rous oxide, xide first rst describing crib g his exp h experience nce in 1882. 88 He later er ppublished ishe an essay e y, ““Consciousness nsci snes Unde deer Nitr Nitrous Ox Oxide,” in 1898, 898 in n which w ch h he noted, note “Looking “Loo ng backk on o my oown exp experiences, es, they t y all converge nverge ge tow towardss a kkindd of insight sigh too which w ch I cannot nno help elp ascr a cr cribing ibin some ome metaphysical etap ical sig nificance. n can The keynote yno of o itt is inv invariably ably a reconcil econ iiation. on. It iss as if the oppposi osiites of the wo world, wh whosee contradictoriness trad orin and conflic onflic ict mak make all oour diff difficultties and troubles, oubl were wer melted elte in into nto unitty.” In n hi his 1902 902 classsic Varieties rietie off Re R Religious ous Experience perie , JJames es ddescribed ribe his vview w of conscio nscciousness. cio snes Nor Normall waking w king consciousness nscio ness “is but one ne sp speci cial al ttype of consciousness, usn whilst wh all about out it, parted part fr from om m it by thee ffilmiest miest of screens, scr s, there th e lie potential oten forms forms of o consciousness usn enti entirelyy dif different.” ent.” Informing Art Osca Wild Oscar Wilde had ad a similar milar experience peri ce uunderr a denttal anesthetic a stheetic andd wr anes wrote rotee Jam James mes in 189 1895: 95: “Th The he n nextt experience I became aware of, who shall relate! I knew everything. A vast inrush of obvious and absolutely satisfying solutions to all possible problems.” French author Guy de Maupassant took ether to soothe his migraines, and one of his many short stories, “Afloat,” features a narrator in a similar circumstance. A byproduct of his relief was “a new way of seeing, judging, appreciating things and life, with the certainty, the complete awareness, that this way was the right one.” De Maupassant is not the only author who apparently turned such a personal experience into fiction. In his short story “Under the Knife,” H.G. Wells put his narrator through an operation at home, and under chloroform, undergoes a near-death experience. His soul seems to leave his body and moves beyond the earth into space. He also describes awareness of the operation: “I do not think I saw. I do not think I heard; but I perceived all that was going on, and it was as if I both heard and saw. Haddon was bending over me, Mowbray behind me; the scalpel ... was cutting my flesh.” American author Theodore Dreiser depicted something similar in his one-act play “Laughing Gas,” originally published in 1915. A physician, Jason James Vatabeel, undergoes surgery to remove a neck tumor with a nitrous oxide/oxygen anesthetic.

‘It was in the year 1860 that there came to me, through necessary use of anaesthetics, a Revelation or insight of the immemorial Mystery which among enlightened peoples still persists as the philosophical secret or problem of the world.’ —Benjamin Paul Blood

elusive ive nature ure of this his experience erie tha that hee ha had a tan tank off n ous oxide nitrous de iinstalled alled in his basement sem and employed mplo d a nurse urse to give giv it to him. m. H He took itt day after fter dayy. Each E h time ti he firmly mly decided cide too re reme member me mb the reall secret et oof the he uuniverse. erse Each ach time me h he w went ent unde der, thee mystic m tic andd awful aw l explanation ex nati was vvouchsafed uch ed him h . But inv B invariably ably when hen he reg regained ed cconsciousness, scio ness, hee could ld no n longer onge remember eme er what w it w was.”” And so itt ha has gone one throughou oug utt h human an h history, ory, thee elusiveness iven of this “re “real secret ecre off the universe.” nive ” Th Thesee ggas inhalation inh ion and d ot other ane anesth thetic th etic experiences peri es from fr m Davy D vy oonward ard can n be b viewed iew wed today tod as tthe brain’s bra s pphysiologic siol c reaction re ion to in naadequate n quat anesthesia nest ia spill s iing into consciousness onsc usne aand memory. mo Yet they ey eechoo descriptions crip ns bby religiou ligiou ous mystics my s from fro many man cultures cultu s and tim time periods. erio More recently, cently, y, ket ketamine ne has become bec me a drug ug used u d iin anes anesthesia sia that at has h created crea d similar sim ar eexperiences rien s noted n ed by b man many recreational ecre onal users. ers. A few more ore serio scholars ous ssch ars aalso ha have exp explored ed that t mental me al state st . These T se include i ude John hn C C. Lilly Lilly, famed ame for or h his dolp dolphin n and iso isolation on tankk research, re arch in his 1978 978 boook Thee Scien SScientist; ntisst; an and nd Mar Marcia rciaa Moore Moooree an and nd h her husb h husband bandd H How Howard Alltounian, in their book, Journeys into the Bright World. Not all accounts of anesthetic mental experiences left to us have been written. A brief article in the November 1992 issue of European Journal of Anaesthesiology describes an oil painting, “Journey into the Kingdom of Narcosis” created by an artist after a 90-minute total IV anesthetic using propofol, fentanyl, atracurium and oxygen-enriched air. In the recovery room she spoke of a “creative explosion” she experienced during the operation. Upon request, she began to sketch the experience, and three months later finished the painting, which is reproduced in color in the article and was donated to the department of the authors in Switzerland. Perhaps these fragments, whether written or painted, are all we can expect from these kinds of intense experiences induced by anesthesia or any other cause. Despite his many verbal and other tools, man has always had trouble describing the indescribable.

D ring thee operation, During op ation Vatabeel Vata l enters en s a darkk niightt oof the soul ul in which hich hee encounters en unte spirits, spir voices, shadows dow and nd ““the rhy rhythm m oof the he uuniverse.” erse Tellin Te nglyy, Dreiser D iser appended pen Blood’s Blo ’s pa pamphlet phle and nd JJamees’ ccomments m nts to t a 192 1926 reprint epri of th the play. Many off the individuals divi als who w hav have left eft thes these se sorts sortss oof records reco ds seem see to h havee be been wr writerss, aand n not alll oof them t m have haave fictionalized—if ficttion nalizzed iff indeed inddeedd that th hat is i what w t Wells and Dreiser did—their experiences remembered while under anesthesia. The Irish playwright J.M. Synge wrote an essay, “Under ether: personal experiences during an operation,” not published until seven years after his death in 1909. “I seemed to traverse whole epochs of desolation and bliss,” Synge wrote. “All secrets were open before me, and simple as the universe to its God.” British novelist R.H. Ward wrote in a memoir of his nitrous oxide dental anesthetic in which he perceived “the interrelatedness of everything.” In 1915, F. Talbot published a remarkable essay in the British Dental Journal, “Psychic Disturbances in Nitrous Oxide Analgesia.” In it he detailed his own mental responses while breathing nitrous oxide in combination with air and oxygen. He wrote of “a sense of the insignificance and distance of all sources of worry and anxiety. The War does not matter now.” Further on he became “conscious of having gained the secret of existence.” But his experiences were fraught with a sense of sadness that “All questions about ultimate realities are practically unanswerable.” Logan Clendening, an American physician and —A.J. Wright, MLS medical historian, described the experience of another, unknown, novelist. “Mr. Carl Van Vechten Mr. Wright is a librarian in the Department of Anesthesiology at [an American writer and photographer] has told me the University of Alabama at Birmingham, and a frequent contribuof a fellow-novelist who became so obsessed with the tor to Anesthesiology News.

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REPORT Optimizing Patient–Ventilator Interaction: Proportional Assist Ventilation and Patient–Ventilator Synchrony Part 2 of a 2-Part Series echanical ventilation (MV) successfully extubated.2 The evalFaculty is a potentially lifesaving uation of objective and clinical intervention but is associated criteria (eg, respiratory pattern, Sanford Levine, MD with a number of complicaadequate gas exchange, hemoAdjunct Professor of Surgery tions such as pneumonia and dynamic stability, and comfort) Department of Surgery and tracheal stenosis.1 Early weanshould be used to determine SBT Pennsylvania Muscle Institute ing or liberating the critically ill success.2 Weaning failure, defined University of Pennsylvania patient from mechanical supas either the failure of a SBT or the School of Medicine port is an important clinical need for reintubation within hours Philadelphia, Pennsylvania goal because liberation results following extubation, after a sinin spontaneous breathing and gle SBT is relatively common and Catherine S. Sassoon, MD Professor of Medicine extubation.2 Weaning delays occurs in approximately 25% to are common in the ICU and may 42% of patients.6-8 Weaning failure University of California, Irvine result from patient– ventilator has a complex, multifactorial pathoDivision of Pulmonary and asynchrony (occurring in 24% physiology that may have psychoCritical Care Medicine VA Long Beach Healthcare System of patients and in ≥10% of their logical, pharmacologic, medical, Long Beach, California breaths), which may prolong and physiologic components. 2 ventilation up to 17 days and Length and difficulty of weaning exposes patients to discomfort attempts may be simple (successand increased risk for complications.2-4 Weaning delays ful first attempt), difficult (3 SBTs or as long as 7 days with prolonged MV are associated with a high cost of from initial attempt), or prolonged (failure of 3 weaning care and higher 6-month mortality rates.2,5 attempts or requiring 7 or more days of weaning after A spontaneous breathing trial (SBT) is the major the first SBT).2 A failed SBT should prompt the clinidiagnostic test used to determine if a patient can be cian to look for reversible contributing etiologies and to

Supported by

REPORT place the patient on a nonfatiguing mode of MV (either assist -control or pressure support ventilation [PSV]).2,6 Approximately 15% of MV patients require prolonged weaning and a tracheotomy may be considered if patients continue to fail to wean after 14 days.2,9 Some patients may not be able to wean or fail weaning trials and SBTs because of the sedation level. Depth of sedation in MV was found to be associated with patientâ&#x20AC;&#x201C;ventilator asynchrony and complicates weaning, impairs respiratory drive, and leads to muscle weakness.10,11 Despite the association of sedation with poor outcomes and prolonged MV, sedation may be employed in the clinical treatment of asynchrony; as demonstrated by Pohlman and colleagues, 42% of ICU patients required additional sedation due to patientventilator asynchrony.12,13 Heavy sedation affects the process of discontinuing ventilator support, underscoring a need to consider consciousness and discontinuation of sedation as part of a weaning protocol.14 Kress and colleagues demonstrated that daily interruptions of sedative infusions reduce the duration of MV and ICU length of stay.15 More recently, a no-sedation protocol was found to be associated with a decrease in ventilator days in critically ill patients.16 Earlier liberation from the ventilator is significant because MV can cause rapid and profound disuse atrophy and weakness of the diaphragm, called ventilator-induced diaphragmatic dysfunction (VIDD).17-20 Using a combination of 18 to 69 hours of complete diaphragmatic inactivity and MV, Levine and colleagues demonstrated marked atrophy of slow- and fasttwitch respiratory muscle fibers.18 To minimize the risk for VIDD, it is important to deliver appropriate partial ventilatory support that facilitates intermittent diaphragmatic contractions.19,21

From PSV to Proportional Assist Ventilation PSV is currently one of the most commonly used partial ventilatory assist modes.22 It reduces workload on respiratory muscles by generating a constant pressure that complements patient effort throughout the inspiratory period.23,24 Compared with earlier ventilatory modes, PSV gives patients more control over when to end inspiration, as the fixed level of inspiratory muscle unloading and patient triggering of the ventilator results in applied pressure (Paw ) rising to a preset level regardless of patient effort.25 However, asynchrony can still occur with PSV because patient conditions are constantly changing and flow demands vary from breath to breath.26,27 Care must be taken with PSV to avoid both insufficient support, leading to increased respiratory muscle load, and excessive support that may result in delayed cycling and other adverse effects (eg, dynamic hyperinflation, intrinsic positive end expiratory pressure [auto-PEEP]).28,29 Proportional assist ventilation (PAV) is designed to amplify patient efforts in a proportional manner without volume or pressure targets, thus optimizing patientâ&#x20AC;&#x201C;ventilator synchrony.30,31 PAV delivers ventilatory assistance based on the patientâ&#x20AC;&#x2122;s respiratory effort, which is clinically valuable because inspiratory effort is variable and, therefore, the level of assistance should vary with it.22,25 PAV is advantageous because 2

it eliminates the need for clinicians to set traditional ventilator parameters (ie, tidal volume, flow rate, inspiratory time, and respiratory rate); the only clinician-determined setting required with PAV is percent support.24,32,33 The necessity for the measurements of respiratory elastance (or compliance) and airway resistance, however, had been an obstacle to widespread clinical use of conventional PAV.31,34-37 More recently, the PAV+ software option was introduced which automatically measures the patient respiratory elastance and airway resistance. The PAV+ software estimates resistance and compliance every 4 to 10 breaths.38 The PAV+ software option has greatly helped to extend the usefulness of PAV technology from research to clinical settings.

Benefits of PAV PAV was demonstrated, in early pathophysiologic studies, to decrease work of breathing (WOB), increase tidal volume, and decrease peak Paw in intubated patients without chronic obstructive pulmonary disease (COPD) during weaning from MV.39,40 Similarly encouraging results were found for PAV in intubated COPD patients including improved minute ventilation, decreased dyspnea, and reduced WOB.39,41 Many studies have shown that PAV allows for improved adaptation of the ventilator to the changing flow demands of the patient, thus improving synchrony between patients and ventilator.42,43 PAV also has been shown to significantly reduce peak inspiratory pressure over a 24-hour period.44 Greater muscle effort is required, and more pronounced patient discomfort has been observed in response to added respiratory load during PSV compared with PAV.22 A retrospective analysis of data from a previous randomized controlled trial demonstrated that PAV+ is associated with fewer interventions in terms of ventilator settings and sedative dose changes compared with PSV.45 A randomized study in the ICU setting demonstrated PAV+ to be an efficient mode of ventilatory support compared with PSV.43 Patients were randomized to receive either PSV (n=100) or PAV+ (n=108) for 48 hours unless patients met predefined criteria for switching to controlled modes or for breathing without assistance.43 Failure rate was significantly lower with PAV+ than with PSV (11% vs 22%, respectively; P=0.040), and the proportion of dyssynchronies was significantly lower in the PAV+ group (5.6% vs 29% respectively; P= 0.001).42 The probability of remaining on spontaneous breathing, instead of switching to CMV, was significantly increased with PAV+ when compared with the PSV group (P= 0.041; Figure).43 The ventilating pressure remained below 30 cm H 2O in 98.2% of measurements in PAV+. This is clinically important because it is recommended that static end-inspiratory airway pressure (Pplat) be maintained below 30 cm H2O to minimize risk for ventilator-induced lung injury.43,46 Short-term respiratory load compensation in critically ill patients may be more efficient during PAV+ than during PSV.32 Kondili and colleagues examined an index of neuroventilatory coupling (the VT to pressure-time ratio product of the diaphragm) of each breath for patterns of respiratory load compensation in response to added mechanical respiratory load in 10 critically ill patients on MV. With PAV+, this

REPORT

Cautions When Using PAV Despite favorable effects that have been demonstrated with PAV and PAV+ (collectively, PAV hereafter), it has limitations. Because the assist varies directly with the intensity of patient effort, and the patient’s respiratory muscles drive the ventilator, PAV must be used with caution in patients with very low respiratory efforts (eg, depression of ventilation, central apneas).25 PAV requires an intact, responsive central controller to maintain an adequate pCO2 and pH. Although patients with altered respiratory drive may be ventilated adequately with PAV, they may have trouble triggering the ventilator.25 PAV is contraindicated if the patient’s central ventilatory drive is unstable due to excessive sedation, central depression of ventilation (eg, brain injury), or central apnea.25 The clinician must correct causes of inefficient drive or switch to a mode with a set rate in the presence of very low respiratory efforts or apnea.2,25 Patient comfort is an important clinical consideration with PAV, as it is with PSV.49.50 Air leaks have been associated with patient–ventilator asynchrony, particularly in noninvasive ventilation, and should be part of the differential when troubleshooting respiratory distress in a patient receiving MV.51 The ability of PAV to compensate for leaks must be evaluated before use as it may vary between ventilator models.33 PAV use may be limited by leak sensitivity, excessive pressure potential (ie, the runaway phenomenon), and the consequences of dynamic hyperinflation.37,52 Reducing the magnitude of dynamic hyperinflation should be a priority. Bronchodilators or corticosteroids may be used, and external positive end expiratory pressure (PEEP) could be used to counterbalance auto-PEEP.37 Care must be taken, especially in critically ill patients, to avoid treating the lung as if elastance and resistance are linear; alinearity of pressure–volume and pressure– flow relationships may cause volume-assist or flow-assist to be set inappropriately.37 PAV is better suited for responding to changing lung mechanics compared with PSV; however, PAV

is similar to other ventilatory modes in that it does not compensate for or overcome the effects of auto-PEEP.33 PAV+ software is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight is at least 55 lb or 25 kg. Patients must be intubated with endotracheal or tracheostomy tubes with an internal diameter of 6 to 10 mm. Patients must have satisfactory neural-ventilatory coupling along with a stable, sustainable inspiratory drive.38

More Tips for Using PAV+ Although PAV+ has been associated with fewer required manipulations of ventilator settings relative to PSV, clinicians generally must individualize ventilatory support based on patient comfort.25,45 A basic PAV application principle is to set PAV at 70% assist, a support level at which distress is uncommon, and to make initial adjustments based on respiratory frequency, using PEEP to overcome auto-PEEP and reducing support gradually (based on patient comfort and with a goal of moving toward a SBT).37 The manufacturer also recommends caution when choosing support values higher than 80%, which may be uncomfortable for the patient.2,25,38 Data monitored and displayed by the PAV+ software include lung compliance and elastance, auto-PEEP, airway resistance, estimated total resistance, spontaneous inspired VT, and normalized rapid shallow breathing index.38 WOB is displayed with PAV+ in the form of a bar graph, with the sum being 100% of the work and the respective work by the patient and ventilator partitioned based on percent work setting and patient variables.25,38 Having multiple patient data readily available through the PAV+ screen display can aid in clinical decision-making that potentially may reduce delays in liberation of patients from MV as a consequence of improved synchrony.

Probability of Remaining On Spontaneous Breathing

index remained relatively independent of load, in contrast to PSV, and the magnitude of load-induced VT reduction and breathing frequency increase was significantly smaller with PAV+ than during PSV.32 Transdiaphragmatic pressure was measured breath-by-breath, per minute, and per liter of ventilation; these values were significantly lower with PAV+ than those with pressure support ([PS]; 5.13±3.7 vs 6.13±3.4 cm H2O; 120.9±78 vs 165.6±77.5 cm H2O/min; and 18.71±15.1 vs 24.36±16.4 cm H2O/L, respectively).32 Some evidence suggests that sleep architecture may be improved with PAV compared with PSV. In a small randomized crossover clinical study that evaluated PAV in 13 patients during weaning from MV, patients receiving PSV had more sleep disruptions per hour (16 compared with 9 in the PAV group; P<0.02) and overall sleep quality was improved in the group receiving PAV.47 Fewer asynchronies were detected per hour in the PAV group (23.7±15.4 vs 52.9±59.2; P=0.0001); this correlated with the number of arousals per hour (P<0.05).47 In a study that evaluated sleep architecture in critically ill patients receiving PAV+, sleep quality was not adversely affected by PAV+ despite the large number of brief end-inspiratory occlusions.48

1.0

0.9 0.8

0.7 0.6

PS PAV+

Log-rank P=0.041

0.5 0

Hours After Randomization Patients at risk, n PS

100

PAV+

108

101

Figure. Kaplan–Meier estimates of probability of remaining on spontaneous breathing (assisted or unassisted) in patients randomized to PS and PAV+. PAV+, proportional assist ventilation with load adjustable gain factors; PS, pressure support Reprinted with permission from Xirouchaki N, et al. Intensive Care Med. 2008;34(11):2026-2034.

REPORT Conclusion PAV is designed with the aim of improving airflow and phase synchrony between patient and ventilator. In addition to being a user-friendly ventilatory mode, PAV has demonstrated efficacy in reducing the frequency of sedative dosing changes, improving respiratory muscle function, reducing peak pressures, and reducing WOB by shifting the

determination of the most appropriate breathing pattern to the patient, thus potentially resulting in a more timely liberation from the ventilator. PAV+, with its capability of automatically measuring respiratory compliance and airway resistance, has greatly helped to extend the usefulness of PAV technology from research to clinical settings.

References 1. Lermitte J, et al. Contin Educ Anaesth Crit Care. 2005; 5(4):113-117.

27. Tokioka H, et al. Anesth Analg. 2001;92(1):161-165.

2. Boles JM, et al. Eur Respir J. 2007;29(5):1033-1056. 3. Thille AW, et al. Intensive Care Med. 2006;32(10):1515-1522.

29. Leung P, et al. Am J Respir Crit Care Med. 1997;155(6): 1940-1948.

28. Sinderby C, et al. Chest. 29(2):329-342.

4. Kollef MH, et al. Crit Care Med. 1997;25(4):567-574.

30. Sinderby C. Am J Respir Crit Care Med. 2003;168(7):729-730.

5. Seneff MG, et al. Crit Care Med. 2000;28(2):342-350.

31. Delaere S, et al. Intensive Care Med. 2003;29(6):949-954.

6. Esteban A, et al. N Eng J Med. 1995;332(6):345-350.

32. Kondili E, et al. Intensive Care Med. 2006;32(5):692-699.

7. Vallverdu I, et al. Am J Respir Crit Care Med. 1998;158(6): 1855-1862.

33. Kacmarek RM. Respir Care. 2011;56(2):140-148.

8. Esteban A, et al. Am J Respir Crit Care Med. 1999;159(2): 512-518.

35. Ambrosino N, et al. Thorax. 2002;57(3):272-276.

9. Masoudifar M, et al. Adv Biomed Res. 2012;1:25. 10. de Wit M, et al. J Crit Care. 2009;24(1):74-80.

37. Georgopoulos D, et al. Int J Intensive Care. 2007; Autumn:74-83.

11. Epstein S. Respir Care. 2011;56(1):25-38.

38. Data on file, Covidien.

12. Kollef MH, et al. Chest. 1998;114(2):541-548.

39. Grossbach I, et al. Crit Care Nurse. 2011;31:30-44.

34. Jolliet P, et al. Crit Care. 2006;10(6):236. 36. Thille A, et al. Clin Pulm Med. 2007;14(6):350-359.

13. Pohlman M, et al. Crit Care Med. 2008;36(11):3019-3023.

40. Navalesi P. Crit Care. 2011;15(181):1-2.

14. Girard TD, et al. Lancet. 2008;371(9607):126-134.

41. Ranier VM, et al. Anesthesiology. 1997;86(1):79-91.

15. Kress JP, et al. N Eng J Med. 2000;342(20):1471-1477.

42. Mitrouska J, et al. Eur Respir J. 1999;13(4):873-882.

16. Strom T, et al. Lancet. 2010;375(9713):475-480.

43. Xirouchaki N, et al. Intensive Care Med. 2008;34(11): 2026-2034.

17. Hermans G, et al. Crit Care. 2010;14(4):1-10. 18. Levine S, et al. N Eng J Med. 2008;358(13):1327-1335. 19. Sassoon CS, et al. Am J Respir Crit Care Med. 2004; 170(6):626-632. 20. Vassilakopoulos T, et al. Am J Respir Crit Care Med. 2004;169(3):336-341. 21. Vassilakopoulos T, et al. Crit Care. 2006;10(1):204. 22. Grasso S, et al. Amer J Respir Crit Care Med. 2000; 161(3 Pt 1):819-826. 23. Prinianakis G, et al. Intensive Care Med. 2003;29(11): 1950-1959. 24. Brochard L, et al. Am J Respir Crit Care Med. 1994; 150(4):896-903.

44. Fisher DF. Presented at: 42nd Annual Meeting of the American Burn Association; March 9-10, 2010; Boston, MA. 45. Xirouchaki N, et al. Intensive Care Med. 2009;35(9): 1599-1603. 46. The Acute Respiratory Distress Syndrome Network. N Eng J Med. 2000;342(18):1301-1308. 47. Bosma K, et al. Crit Care Med. 2007;35(4):1048-1054. 48. Alexopoulou C, et al. Intensive Care Med. 2007;33(7): 1139-1147. 49. Prinianakis G, et al. Eur Respir J. 2004;23(2):314-320. 50. Vignaux L, et al. Intensive Care Med. 2009;35(5):840-846.

25. Davies J. Essential Practices in Respiratory Care. 2011.

51. Santanilla JI, et al. Emerg Med Clin North Am. 2008; 26(3):849-862.

26. Beck J, et al. App Technol Mech Ventilation. 2011:1-5.

52. Passam F, et al. Respiration. 2003;70(4):355-361.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright ÂŠ 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

SR1219

Disclosures: Drs. Levine and Sassoon reported no relevant financial disclosures.