The November 2012 Digital Edition of Anesthesiology News

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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • N o v e m b e r 2 0 1 2 • Volume 38 Number 11

40th Anniversary 1972-2012

Seeking Solutions To Failed Extubation New algorithms could fill critical safety gap

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ashington researchers have set out to address the “huge problem” of extubation failure, saying an algorithm they have developed is 70% accurate in predicting extubation failure.

Approximately 20% of patients require reintubation, which raises their risk for morbidity and death (Resp Care 2012 Feb. [Epub ahead of

New Data Bolster Concept Of Surgical Homes mes Led ogists

By Anesthesiolo

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he American Society of Anesthesiologissts is hoping the concept of the “surgical home” will help shelter its members from forces now buffeting the specialtt y, from ever-increasingg quality care initiatives to the rise of accountable care organizations.

The society in recent years has pushed the surgical home model, a coordination of perioperative care that improves efficiency, as a way for anesthesiologists to demonstrate their value within a health care institution. Yet it has had little in the way of data to support the argument—until now.

A handful of new studies could help the

see extubation page 16

see home page 14

INSIDE

Arctic Beckons Again For Harvard Anesthesiologist

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arren Zapol has one of the coolest jobs in anesthesiology. Or at least the coldest.

In August, President Barack Obama reappointed the Boston-based anesthesiologist to sit on the U.S. Arctic Commission (USARC), which shapes the country’s research goals for the region.

Now in his second term, Dr. Zapol, director of the Anesthesia Center for Critical Care Research at Massachusetts General Hospital and the Reginald Jenney Professor of Anaesthesia at Harvard Medical School, relishes his work on Earth’s final frontier.

“We need to learn a lot more about the Arctic. It’s a bit like going to Mars—the only place on Earth where you can still pick up a rock and be the first person to

10 | PAIN MEDICINE

look at it,” Dr. Zapol said in an interview.

With heightened geopolitical and industry interest in the region, due in part to new opportunities brought about by climate change, the stakes are Warren Zapol, MD high for all of its inhabitants.

Dr. Zapol—well known for his research on nitric oxide and hypoxia in neonates—and a handful of other commissioners representing science, industry and the indigenous peoples of the area, will be recommending policy to the president and Congress.

Opioids for chronic pain: how to prescribe responsibly.

17 | CLINICAL ANESTHESIOLOGY A surgical checklist for the office-based anesthesiologist.

32 | TECHNOLOGY Tablet app offers better gauge of blood loss during surgery.

34 | COMMENTARY For the sake of your patients, take time to look at the mountains.

see arctic page 30

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4 I AnesthesiologyNews.com

NOVEMBER 2012

Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First: There is something occurring during surgery that is resulting in an increase in

cerebral edema

November 2012

The five most-viewed articles last month on AnesthesiologyNews.com

and in how different areas of the brain

1. As Liposuction Deaths Mount, Study Exposes Cracks in Safety 2. Anesthesia Depth Not Linked to Post-op Outcomes 3. Regional Anesthesia for Total Joint Arthroplasty (Educational Review) 4. Anesthesia and the Crashing Patient (Educational Review) 5. Postoperative Opioid-Induced Respiratory Depression: Current Challenges and New Developments in Patient Monitoring (Special Report)

are connected. Now, we can start to try to

understand why it’s occurring, which will lead to ways to

control it.

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6 I AnesthesiologyNews.com

NOVEMBER 2012

P A IN M E D I C I NE

MD Trainees Wary of Ordering Opioids for Chronic Pain

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any physicians-in-training are reluctant to prescribe opioid analgesics for longterm pain management, a recent study has found.

“Most surveys are done with family medical practitioners,” said Ike I. Eriator, MD, MPH, professor of anesthesiology and pain management at the University of Mississippi Medical Center

in Jackson, who led the study. “But if we look at how physicians-in-training think, it gives us a clue as to what a practitioner of the future might do.”

The study results were presented at the 2012 annual meeting of the American Pain Society (abstract 242).

The researchers queried 93 trainees from the areas of emergency medicine, general surgery, psychiatry,

internal medicine, family medicine and neurology, as well as 16 medical students about their pain treatment practices. Nearly half (45%) said they treated chronic pain on a regular basis. Twenty-one percent of respondents stated they felt comfortable treating chronic pain, whereas 34% felt it depended on the situation. However, 81% reported feeling uncomfortable

prescribing long-term narcotics for chronic pain patients.

There was no significant relationship between treating chronic pain on a regular basis and comfort with prescribing long-term narcotics among the physicians. Women were more likely than their male colleagues to feel uncomfortable prescribing long-term narcotics. Trainees who felt comfortable managing chronic pain also were significantly more likely to feel comfortable prescribing long-term narcotics.

The most common concern with prescribing long-term narcotics was the risk for chemical dependency or addiction (37%), closely followed by escalating opioid doses (35%); 3.4% of respondents cited legal considerations.

“A few decades ago, the legal environment was the main impediment to prescribing opioids,” Dr. Eriator said.

“Maybe that has changed because law enforcement has relaxed its prosecution over recent years of medical practitioners who prescribe opioids.”

Dr. Eriator said the results of the study could be used to help focus pain management training in the areas where residents are most deficient.

“At an anesthesiology meeting several years ago, we presented data that showed residents’ knowledge of acute pain treatment varied across specialties,” he said. “For instance, orthopedic residents were more likely to attribute increasing requests for medication to the development of tolerance, while family medicine residents would attribute it to addiction. We could focus their education on the areas where they need more knowledge.”

Dr. Eriator said he would like to use the same questionnaire to survey medical students on their comfort level and concerns regarding pain management and how it changes when they become physicians.

A healthy respect for how complicated it is to treat pain is a good thing, said Steven Passik, PhD, professor of psychiatry and anesthesiology at Vanderbilt University School of Medicine in Nashville.

“Medical education on pain and addiction is sorely lacking, and training about the interface between pain and addiction is virtually nonexistent,” he said. “We should teach the physicians-in-trainingg to use their discomfort to seek training throughout their career.”

—Dana Hawkins-Simons

NOVEMBER 2012

AnesthesiologyNews.com I 7

PA IN M E D ICIN E

RF Neurotomy Seen Effective for Whiplash Pain

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ervical radiofrequency neurotomy appears to significantly reduce pain and other symptoms in individuals with chronic whiplash-associated disorder (WAD).

Canadian and Australian researchers found 38 of 58 patients in their prospective study experienced significant reductions in cervical pain intensity, selff reported neck pain and disability and psychological distress— along with significant improvements in sensory hypersensitivity and overall well-being—in three months after undergoing neurotomy in the neck region. The researchers presented the results at the 2012 World Congress of Pain (abstract PH098).

“Until now, individuals with chronic WAD presenting with widespread bodily pain and hypersensitivity have been noted to have a poor recovery— but our findings demonstrate that improvement is possible,” said Ashley Smith, director of Evidence Physiotherapy at the Advanced Spinal Care Centre in Calgary, Alberta, who led the study.

The investigators recruited patients aged 18 to 65 years who had grade 2 WAD and neck pain for at least six months and who were candidates for neurotomy in the neck region.

All of the subjects had received prior treatment, including medication, massage, physiotherapy, chiropractic and interdisciplinary therapy at a chronic pain clinic. Many continued these treatments post-neurotomy. y Seven patients did not experience improvement immediately after surgery. However, all remaining patients noted significant improvement in the first month. Six patients were lost to follow-up and another seven had recurrent neck pain within three months.

The 38 patients who remained improved at three months experienced a significant reduction in pain on the visual analog scale from before surgery to one and three months postprocedure. They also experienced significantly reduced scores on the Neck Disability Index and significantly increased Short Form-36 Health Survey scores.

The 38 subjects showed significant improvement on several other measures, including the Pain Catastrophization Scale and the General Health Questionnaire-28.

“Twenty-four of these 38 patients had other injuries or areas of pain and were receiving other treatments for it

until the day of neurotomy, without any note of improvement until they received radiofrequency neurotomy,” Ms. Smith said. “Also, we investigated all subjects twice before the procedure, 11 months apart—there is a 12-month waiting list here in Canada—and there were no changes in the physical or psychological measures prior to receiving neurotomy, even among those who

were being treated at a chronic pain center.”

The team hopes to determine if use of supplementary treatments, including medication, decreased postprocedure.

David Solsberg, MD, a neuroradiologist and interventional pain physician in Englewood, Colo., gave the work a mixed review. “There is not enough evidence in this presentation to change

the current stan ndard of care foor whiplash, but the study should gen nerate enthusiasm for either a case–conttrol study or a case–sham ham neurotomy study,” Dr. Solsbergg said.

—Rosemary Frei, MSc

8 I AnesthesiologyNews.com

NOVEMBER 2012

P A IN M E D I C I NE

Painting Pain as a Therapeutic Outlet

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eather Bolinder remembers the pain. In fact, she will never forget it. The trained emergency medical technician and nursing assistant had helped others in discomfort before, but she had never felt such agony herself. That is, until that one July day nearly five years ago.

Ms. Bolinder was in her garden, tending to her flowers, when suddenly

she felt what she now describes as an “excruciating” pain in her back. She couldn’t move. Family members came to her aid and rushed her to the emergency room at a local hospital. It was the first of many visits to hospitals, physicians and specialists as part of a seemingly never-endingg effort to get an accurate diagnosis of, and proper treatment for, her pain.

Largely bedridden for more than a year, Ms. Bolinder was forced to give up her job as a nursing assistant as well as her avocation: painting. Even though she knew her art would make for great therapy, she just couldn’t bring herself to pick up a brush—even after a lifetime of painting the nautical scenes that surround her native Cape Cod, Mass. It was a visit to her

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long-time family practitioner that changed the course of her chronic pain and, ultimately, her recovery.

“I got depressed and lost hope,” Ms. Bolinder says now. “My focus became just getting up and getting through the day. My doctor knows me so well, knows how much painting means to me. He told me, ‘Paint your pain.

You’d feel better if you painted what you’re feeling.’”

The physician’s advice took Ms. Bolinder by surprise. She hadn’t thought about painting her suffering, and wasn’t even sure she knew how to go about it. In the end, however, these musings brought her to the point where she could stand in front of the canvas again.

In late December, with the help of her fiancé, Ms. Bolinder launched an online gallery of her work called paintingpain.com. She has nearly

NOVEMBER 2012

AnesthesiologyNews.com I 9

PA IN M E D ICIN E specialist at PainCare, a pain clinic in New Hampshire. Mr. Clough also has started his own Web site called medicalspeakinenglish.com, which is designed as a patient education resource.

“Heather’s paintings give a voice to pain patients,” Mr. Clough said.

He believes her work “captures the essence” of what patients experience and that the added insight can only help chronic pain sufferers.

Ms. Bolinder’s partnership with Mr.

Clough and her efforts to use her art for the good of patients with chronic pain remain works in progress. She’d love to create a “visual scale” that patients can use to describe pain symptoms and their severity, something that would replace what she calls the “outdated” numeric rating scale. For now, however, painting pain continues to be therapeutic, both for her and many of those who visit her site.

“I have a vision that I will be able to do a traveling show with my work and

that a pain specialist will come and talk about what pain feels like,” Ms. Bolinder notes. “For patients, chronic pain is a constant mind journey to, one, not be depressed and two, to continue doing what you love to do. Through my art, I’m able to reach people who are going through the same thing I did. I tell them we’re in this together and it’s so much easier when you have a team.”

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Covidien is proud to announce that Oridion Systems is now a part of the Covidien family 30,000 online followers now, many of whom post their own stories on the site. Although the painting did not help her pain—drugs and physical therapy did—it helped her feel less depressed and got her back to work.

Using her own pain history and those of the site’s visitors as inspiration, Ms. Bolinder’s paintings attempt to visually describe pain symptoms as well as the emotional effects of chronic pain.

As a professional artist, Ms. Bolinder could sell her work (her nauticalthemed paintings have been shown and sold in local galleries), but that’s not part of the plan, at least not for now. Her goal is to partner with medical professionals in the pain field to use her work to educate patients and their families on chronic pain and its management. Recently, she has been working with Christopher Clough, a physician assistant and pain

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2. Stoelting R, Overdyk F. Anesthesia Patient Safety Foundation, Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression. http://www.apsf.org/announcementsphp?id=7. Accessed August 25, 2011.

3. Standards for Basic Anesthetic Monitoring. American Society of Anesthesiologists. http://www.asahq.org/For-HealthcareProfessionals/~/media/For%20 Members/documents/Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitoring%202005.ashx. Accessed June 20, 2011.

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10 I AnesthesiologyNews.com

NOVEMBER 2012

P A IN M E D I C I NE

Responsible Use of Opioids for Chronic Pain

overdose in the national spotlight. The practitioners at Arizona Pain Specialists (APS) feel the data do not support the use of high-dose opioids, but will Dear Arizona Pain Specialists, prescribing doses of opioids that have Dear Pill Paranoia, use low- to moderate-dose opioids for My partner and I recently started escalated to levels that make us uncomhese concerns are common to certain patients. After researching the an interventional pain practice. We fortable. How can we improve opioid pain practices across the coun- medical literature, national recommenboth feel that opioids have a role in compliance and minimize risk both try. Although opioids can be dations and Drug Enforcement Adminthe treatment of chronic pain, but we to the patients and to ourselves, the beneficial in the treatment of pain in istration (DEA) guidelines, we created certain patients, the frequent news a 12-Step Compliance Checklist to wonder if the prescriptions for opi- practitioners? reports of prescription drug addiction use when prescribing opioids (http:// oids that we write for patients, some for high doses, are really being taken Thank you, and overdose fatalities have placed opi- boostmedical.com/services/complias prescribed. We have found ourselves Pill Paranoia oids and their potential for abuse and ance/opioid-compliance; Table).

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Criteria for Opioids The Centers for Disease Control and Prevention (CDC) has reported that the number of drug overdoses in the United States tripled from 1991 to 2007 and that prescription drugs accounted for much of that increase. In 2008 alone, there were 14,800 deaths in the United States involving opioids.1 The mortality rate of those taking opioids is strongly related to the dose taken. Gomes et al found that patients taking high doses of opioids (200-400 mg morphine equivalent [mEq] per day) had an opioid-related mortality rate nearly five times greater than those taking moderate doses (up to 200 mg mEq per day).2 In order to justify the risks involved with taking opioids, one of the goals of our opioid compliance checklist is to determine whether patients meet the criteria for the medications. The 0- to 10-point pain scale is used to determine if the patient has moderate to severe pain. If not, other, nonopioid medications would be more appropriate. Upon examination of a new patient, unless the patient has severe pain, we initially try conservative therapy and non-narcotic medication, before prescribing opioids.

The diagnosis for which the opioids are prescribed should be clearly documented. Documentation also should include a complete physical examination, including detailed targeted physical examination of the area involved. If the diagnosis is in question, additional diagnostic exams including imaging may help guide your decision. In general, we feel that the doses of opioids should be proportionate to the severity of the disease. For example, an individual with multiple failed back surgeries in the past would necessitate higher opioid doses than a 22-year-old with no known pathology, a near-normal magnetic resonance imaging test and no prior opioid use.

The risks and benefits of opioids should be clearly explained to patients so they can make an informed decision.

NOVEMBER 2012

AnesthesiologyNews.com I 11

PA IN M E D ICIN E In some cases, after learning about the unwanted side effects, including the risk for death and addiction, the patient will decide to pursue other medications or modalities to treat his or her pain.

Determining the patient’s goals of opioid treatment is an important element of the compliance checklist.

Patient goals often focus on their ability to function, such as walking through the supermarket or hiking their favorite trail. This helps to monitor the effectiveness of the opioids once they are prescribed. We find that some patients expect to be completely pain-free with the use of opioids. However, the available evidence indicates a more realistic expectation is a 30% mean reduction in pain intensity over time.3 With the potential benefit set at a 30% reduction and not complete resolution, some patients may opt for other options given the relatively high risk associated with the drugs.

Upper Dosing Limit If you are in a group with multiple physicians and mid-level providers, it is important to discuss and formulate an overarching philosophy in regard to opioids. For instance, at APS, we aim to reduce each patient’s opioid doses as much as possible, with the goal of discontinuation, if warranted. Also, we strive to write for low to moderate doses of opioids, with 150 mg mEq per day as an upper limit. Having the same philosophy with clear limits helps to keep the patient’s care on the same track, even when the patient sees different providers within the same group.

Risky Behavior Another goal of the compliance checklist is to identify those patients with abuse potential. A history of drug or alcohol abuse or of psychiatric illness (prior suicide attempt, major depression, schizophrenia, borderline personality disorder, bipolar disorder, etc.), and prior release from other pain clinics for noncompliance should be strongly considered before starting or continuing opioid medications.

It is important to monitor each patient’s compliance once opioids are initiated; this should be done across the board, regardless of the patient’s age or how nice or professional the patient seems. Physicians are notoriously inaccurate when attempting to guess who is abusing drugs. Also, if you treat all of your patients the same, no one will feel singled out or profiled. At APS, we monitor those receiving opioid prescriptions with monthly

pharmacy board reviews and regular urine drug screening.

In 2011, the White House’s Office of National Drug Control Policy released the report “Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” which specifically emphasized the use of prescription drug monitoring programs (PDMPs) to assist in patient care, evaluate interventions and investigate drug diversion and insurance fraud.4 As of Oct. 16, 2011, 37 states, including Arizona,

had operational PDMPs. In Arizona, we can obtain data including the name of the narcotic, the date prescribed and filled, the prescriber’s name, the quantity dispensed and the dispensing pharmacy. At APS, the updated pharmacy board data are reviewed at each opioidrefill appointment, typically monthly.

If the patient is filling narcotic prescriptions written by providers outside of APS, the patient is in breach of his or her pain contract. According to the CDC, patients prescribed

high daily doses of opioids and seeking care from multiple doctors are at high risk for overdose themselves and are more likely providing the drugs to others who are using them without prescriptions.5 Paulozzi et al found that the risk for unintentional prescription drug overdose increases with even two prescriptions, providers or pharmacies within six months. The strongest predictor of overdose was the number of pharmacies that a patient uses.6 see responsible page 12

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NOVEMBER 2012

P A IN M E D I C I NE RESPONSIBLE

CONTINUED FROM PAGE 11

At APS, we also perform regular urine drug screening exams to check for inconsistencies such as unexpected positive results, suggesting that the patients are taking medications that are not prescribed by you, and unexpected negative tests, suggesting the patients are not taking their medications at all. The physician also should be alert to possible adulteration of the urine sample. If collected within four

minutes of testing, the temperature of the sample should be between 90 and 100 F, the pH should be between 4.5 and 8.0 and the creatinine at least 20 mg/dL. A common question is what to do when a patient requests an early medication refill or has inconsistencies on his or her pharmacy board review or urine drug screen. Although some advocate a strict three-strikes philosophy, at APS we evaluate each case individually. Whichever consequences you

choose to apply for noncompliance should be explained to the patient on initiation of the opioid.

follow-up appointment three to nine months after their initial visit. We found that, by using the Boost Medical 12-Step Compliance Checklist Opioid Compliance for Long-term Opioid Therapy and Program Results aggressively weaning down from highAfter implementation of the Boost dose opioids, the patients’ average Medical 12-Step Compliance Check- daily dose of opioids were reduced by list for Long-term Opioid Therapy at 34% (from 73.8 to 48.7 mEq per day).

APS, we performed a random chart A paired samples t test demonstrated review of 93 new patients, compar- that this reduction was statistically ing their opioid doses at their initial significant (t[92]=4.15; P<0.0001). consultation to their opioid doses at a In addition, 17.2% of these patients were completely taken off opioid medications.

Read the #1 anesthesiology publication in the country anywhere, anytime.

Conclusion Opioids are an integral part of an interventional pain practice, but come with substantial potential risk to the patient and practitioner. To assess for appropriateness of use and noncompliant behavior, at APS we have implemented the Boost Medical 12-Step Compliance Checklist for Long-term Opioid Therapy. Using a compliance program and setting boundaries within your practice, such as upper limits of opioid dosing, will help you to feel comfortable when using opioids to treat your patients.

—Paul Lynch, MD, Tory McJunkin, MD, Jack Anderson, MD, and Edward Swing, PhD Drs. Lynch and McJunkin own and operate Arizona Pain Specialists, a comprehensive pain management practice that provides minimally invasive, clinically proven treatments, with three locations in the greater Phoenix area. Drs. Lynch and McJunkin also provide consulting services to other pain doctors around the country through their partner company, Boost Medical. For more information, visit ArizonaPain.com and BoostMedical.com.

References 1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. http://www.cdc. gov/mmwr/preview/mmwrhtml/mm6043a4.htm.

Accessed April 23, 2012.

2. Gomes T, Juurlink DN, Dhalla IA, et al. Trends in opioid use and dosing in the socioeconomically disadvantaged. Open Med. d 2011;5(1):E13-E22.

3. Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372-380.

4. The White House. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. http://www. whitehouse.gov/sites/default/files/ondcp/issuescontent/prescription-drugs/rx_abuse_plan_0.pdf.

Accessed June 22, 2012.

5. Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses—a U.S. Epidemic. http://www.cdc.gov/mmwr/preview/ mmwrhtml/mm6101a3.htm?s_cid=mm6101a3_w.

Accessed April 23, 2012.

6. Paulozzi L, Kilbourne E, Shah N, et al. A history of being prescribed controlled substances and risk of drug overdose death. Pain Med. 2012;13(1):87-95.

NOVEMBER 2012

AnesthesiologyNews.com I 13

POL ICY & M A N A G E ME N T

Dramatic Rise in Hospital Visits for C. Difficile

D

espite efforts by the U.S. Department of Health and Human Services and antimicrobial stewardship programs to combat Clostridium difficilee infections (CDIs), the national rate of hospitalizations related to these infections is projected to more than double from 2001 to 2012, according to a report from the Agency for Healthcare Research and Quality (AHRQ).

“It has been known that C. difficile hospitalizations are increasing,” said the report’s lead author, Claudia Steiner, MD, MPH, senior research physician at AHRQ, in Rockville, Md. “One thing our report adds is data that projects out to 2011 and 2012. Often health care data is behind by a couple of years.”

From 2001 to 2010, the national rate of C. difficile hospitalizations per 1,000 nonmaternal adult discharges rose from about 5.6 to 11.5. The projected rate climbed to 12.5 in 2011 and is projected to climb to 12.8 in 2012.

Results were obtained not only for the nation overall but also for the nine census divisions, which showed variation. New England states had the highest rate of C. difficile hospitalizations both in 2001 (average, 7.7) and 2010 (average, 13.7), whereas the west south central states (Arkansas, Louisiana, Oklahoma and Texas) had the lowest rate in 2001 (average, 4.5) and 2010 (average, 9.1).

Dr. Steiner said the reasons for the regional differences were unclear.

“It could be differences in use of antibiotics, in diagnosing and coding of C. diff or in the threshold to admit a patient. ... Our report shows the [rate in the] Northeast is flattening—does this mean hospitals have changed something in their approach or that the health care community is intervening?”

Debra Goff, PharmD, an infectious disease pharmacist at The Ohio State University Medical Center, in Columbus, who was not involved with the report, said it was “a wake-up call to hospitals to get an action plan in place now—because the consequence to patients can be death. C. difff infection is a disease for which CMS [Centers for Medicare & Medicaid Services] will require public reporting in 2013.”

Acknowledging that the report had limitations, Dr. Steiner said, “Our report shows burden of illness rather than incidence or causation. Because some patients may have been readmitted, the number of hospitalizations may represent fewer patients.”

Dr. Gofff said the analysis “excluded large hospitals and teaching hospitals. It’s representative of small community hospitals, which the lion’s share of C. difff patients aren’t in. Possibly it underestimates rates of C. difff hospitalization.” Even so, she said, the report gives practicing pharmacists “a benchmark to compare your own rates of C. difff to other hospitals nationally.

“I’d like to think stewardship programs are the reason” for the plateaus seen in some areas of the country, Dr. Gofff added.

She stressed, however, that “until all health care facilities make prevention of C. difficile infection a priority, lower rates may not be realized for some time. Publicly reporting CDI rates and reducing hospital reimbursement

for preventable diseases [such as CDI] will expedite putting CDI on the radar screen of health care facilities. Pharmacists can help empower patients through education and increased awareness of how to prevent CDI. Patients are the reason we do stewardship.”

—George Ochoa Drs. Goff and Steiner reported no relevant financial conflicts of interest.

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14 I AnesthesiologyNews.com

NOVEMBER 2012

P OLI C Y & M A NAGEMENT HOME

CONTINUED FROM PAGE 1

ASA—and those anesthesiologists who believe in the idea—better make its case that surgical homes indeed help improve care while reducing costs. The studies, presented at the ASA’s 2012 annual meeting, address different aspects of perioperative medicine.

Each found encouraging signs that when anesthesiology departments take a more active role in the overall management of surgery patients, those patients do better and at less expense to the hospital.

Robert Johnstone, MD, who supported development of the surgical home concept as vice president for professional affairs for the ASA, commended the research groups. “Anesthesiologists are the bestpositioned physicians to lead surgical homes. As anesthesiologists begin implementing and studying the principles of surgical homes, data will emerge measuring their effects,” said Dr. Johnstone, professor of anesthesiology at West Virginia University, in Morgantown.

Although the data from the new studies are preliminary, Dr. Johnstone said they are encouraging for supporters of surgical homes. If the hospitals involved “can develop a surgical home model that improves outcomes, reduces costs and can be used by other institutions, they will have achieved a lot, and advanced health care.”

More Hands, Not Handoffs In one study (abstract 708), Mark W. Haney, MD, and Duraiyah Thangathurai, MD, of the University of Southern California Keck Medical Center, in Los Angeles, analyzed the effect of their department’s version of the surgical home on 30-dayy mortality.

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At Keck, anesthesiologists work with surgeons to develop a care plan that spans from the day before surgery until the patient leaves the ICU. The team— which typically consists of three anesthesia attendings and the same number of anesthesia residents, as well as more residents who rotate through—charts a detailed treatment plan, particularly for critically ill patients, with contingencies in case things change.

In either case, he said, the focus is on a good long-term outcome, not simply immediate success in the operating room. The entire Thomas Vetter, MD, of the University of Alabama at team is present for every induc- Birmingham, reviews a patient care plan with a nurse in the tion, line placement and critical Preoperative Assessment, Consultation, and Treatment (PACT) event during the case.

Clinic.

That’s a lot of additional white coats and scrubs, Dr. Haney acknowledged, and the rooms can get a bit cramped. cardiovascular disease. This has enabled the team to The upside, however, is that “now we have six people give additional care without the need for consultawho are intimately aware of everything that is going tion, which decreases overall costs.” on with the patient.”

Streamlining Perioperative Testing Some of the operative nurses think it’s a little chaThe second study (abstract 280) looked at the ecootic when a large group comes in, he said, whereas others like it because of the extra hands. “But the nomic impact of an anesthesiology-led triage proICU nurses love it because they know all about the gram at Ochsner Medical Center, in New Orleans. patient and all the events that happened in the OR Under the program, which began in early 2010, Ocheven before the OR circulator has called them. They sner anesthesiologists review medical records, order laboratory and other preoperative tests and manage feel they have more time to plan and prepare.”

Patients, too, have responded well to the system, consultations for patients undergoing knee and hip and to getting more contact with the anesthesiol- replacements at the facility. ogists beyond the few minutes before induction of Armin Schubert, MD, chair of the Department of anesthesia. “They like having that familiar face. It has Anesthesiology at Ochsner, said the impetus for the had a very positive impact on how they feel about triage system was the recognition that many surgery patients undergo batteries of redundant, expensive their care,” he said.

Dr. Haneyy said the roots of the Keck model extend tests that are counter to the latest guidelines. back about 20 years, when the hospital’s oncologists “We still observe that a patient who comes for a began requesting certain anesthesiologists for their routine procedure, who is healthy, often will have sickest patients. a laboratory test, maybe a chest x-ray, y even an EKG “The attending began to care for these patients in [electrocardiogram] ordered by either the surgeon the ICU postoperatively as part of the anesthesia or the primary care physician the surgeon consults resident training,” Dr. Haneyy said. “Over time, this for clearance,” Dr. Schubert told Anesthesiology News. grew into requests for any of the attendings from this team, as the surgeons felt that the care provided for their patients was far better than it had been under Table. Tests per 100 Patients pulmonary critical care. Now, there are more surgeon Triage Non-triage Triage Non-triage requests for this team than there are team members.”

Test ASA II ASA II ASA III ASA III Looking at data from 2010 and 2011, Drs. Haney APTT 3 57 5 68 and Thangathurai found that 30-dayy mortality was 47% lower when patients received care from the peri- PT/INR 100 79 94 95 operative team than before the system existed.

67 45 67 59 Dr. Haneyy is now analyzing the effect on hospi- BMP tal costs of the surgical home model. Preliminary CMP 22 61 19 66 data suggest that the system shaves about a halff day 89 100 92 129 from the average length of stay—a savings that, if real, CBC EKG 47 76 50 70 would be significant.

Meanwhile, because the team requires no addi- CXR 12 58 8 55 tional staff, it’s cost-neutral to the hospital. In fact, Dr. Haneyy said, it likely saves money. “The attend- Each triage group was statistically significant at PP<0.01 when compared to ASA I ings are trained in more than anesthesiology and non-triage. activated partial thromboplastin time; BMP, basic metabolic panel; CBC, critical care,” Dr. Haneyy noted. “They also have APTT, complete blood count; CMP, comprehensive metabolic panel; CXR, chest x-ray; EKG, electrocardioggram;; PT/INR, prothrombin prothrombin time expertise in the management of pain, addiction and electrocardiogram;

NOVEMBER 2012

AnesthesiologyNews.com I 15

POL ICY & M A N A G E ME N T “This is a time-honored practice, and it exists all over the country.”

However, several centers, including Cleveland Clinic and Mayo Clinic, have demonstrated that anesthesiology-directed preoperative triage can eliminate redundant testing, he said, while boosting throughput and efficiency on the day of surgery.

Dr. Schubert’s group compared rates and costs of preoperative testing before and after the hospital implemented the triage program. They found that, for every 100 patients, the program saved approximately $18,000 in testing costs.

Most unnecessary tests involved studies of electrolytes, kidney function and other chemistry assays, EKGs and chest x-rays, as well as the APTT clotting test in patients with no history of a bleeding disorder (Table, page 14).

“Overall, the care of the patient was more focused, more based on evidence and on clinical need,” he said. And the triage program didn’t simply lead to less testing. “In some cases a test was even added where necessary,” he said.

Dr. Schubert said the results were encouraging enough that Oschner— which performs roughly 25,000 procedures per year that require anesthesia—is expanding the triage program to include other surgical patients.

“We believe this is a substantial opportunity for savings,” he said.

His own back-off the-envelope estimate that such a system applied to the 40 million-odd surgeries performed each year nationally could save roughly $80 million annually.

Focus on Anemia In the third study (abstract 834), researchers at the University of Alabama at Birmingham (UAB) looked at the impact of that institution’s preoperative anemia management program for patients undergoing total hip arthroplasty. Under the program, called PAMP, anesthesiologists ensure that patients receive testing for anemia before surgery. If their hemoglobin and iron levels are low, the anesthesiologist orders weekly doses of erythropoietin and IV iron, said Thomas Vetter, MD, MPH, who oversees the PAMP. “We were struck by how many of these patients had anemia that would be a candidate for erythropoietin and IV iron,” said Dr. Vetter, vice chair of UAB’s Department of Anesthesiology. Although treating anemia in surgery patients is not a novel idea, he added, few if any studies have looked at whether doing so can reduce blood transfusions and allow patients to

go home with normal hemoglobin— which, in turn, might improve their rehabilitation.

The answer, at least from Dr. Vetter’s limited study, appears to be yes. The UAB researchers identified 128 anemic patients among the 358 they studied, for a rate of 39%. Those patients received 352 units of red blood cells during surgery—at a cost of $352,000, or just under $1,000 per unit. Had those same patients received anemia therapy, however, the cost would

have been $245,000, or a savings of $107,000, they reported.

Dr. Vetter said the department has embraced the results and plans to fold the PAMP into its Preoperative Assessment, Consultation, and Treatment (PACT) Clinic for other semi-elective surgeries. Both will comprise parts of UAB’s surgical home. Everyone from the surgeons and nurses to the hospital administration back the plan, he said.

Of course, nothing succeeds like success, and Dr. Vetter acknowledged that

anesthesiologists do not hold the deed to the surgical home in every hospital. “The case has yet to be made by the ASA or by groups like ours that we can do this in a more cost-effective manner than internal medicine hospitalists,” he said. “There is no corner on the market.”

But, he added, “I think it’s a wonderful opportunity for our specialty, and I think ultimately it will be beneficial for patients, which is what it’s all about.”

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16 I AnesthesiologyNews.com

NOVEMBER 2012

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

burden for those successfully extubated and the 19% of patients who required print]). Compounding the problem, reintubation. although criteria exist for extubation, From 14 to Four guidelines do not exist for the normal, nondifficult airway.

An initial analysis identified 14 “The [new] algorithm is meant to be variables that differed significantly incorporated into a more comprehen- between extubation successes and failsive checklist that allows screening for ures (Table). However, the study popextubation readiness, stratification of ulation was large and some statistically patients based on their risk for extu- different values between the two bation failure and implementation of a groups were not necessarily clinically specific extubation plan,” said Miriam significant, Dr. Treggiari said.

Treggiari, MD, PhD, MPH, director Subsequent multivariate regresof research in critical care and profes- sion modeling found four of the 14 sor of anesthesiology at the University variables—physical status on admisof Washington School of Medicine, in sion to the ICU, the ratio of PaO2 Seattle. Dr. Treggiari presented pre- to FiO2 after a spontaneous breathliminary data on the algorithm at the ing trial, suction frequency and SpO2 2012 annual meeting of the Ameri- prior to extubation—jointly predicted can Society of Anesthesiologists (ASA; approximately 70% of reintubations abstract 689). required within 24 hours of extubation.

To meet the clinical need for a better The addition of more variables “only approach to assessment, Dr. Treggiari slightly” increased the predictive abiland her colleagues analyzed data from ity of the model, Dr. Treggiari noted.

2,008 of their ICU patients who had Her group has prospectively colbeen intubated in 2007. They com- lected six months of pre-algorithm pared demographic data, hemody- baseline data and are now recording namic variables, blood gas values, physician adherence to the algorithm neurologic exam findings and secretion and documenting rates of extubation CONTINUED FROM PAGE 1

failure when it is used. “We will be presenting our findings from the prospective cohort and sharing the algorithm itself at next year’s ASA meeting,” she added.

Ram Roth, MD, assistant professor of anesthesiology at the Mount Sinai School of Medicine, in New York City, is developing a separate extubation algorithm (see Anesthesiology News Guide to Airway Management, August 2012, page 69). Dr. Roth, who was not involved in the Washington study, said the need for guidelines to improve extubation success is critical.

“The ASA has been asking for practical, useful prestructured extubation guidelines for several years now but have not made any meaningful progress, so extubation failure remains a huge problem,” he said.

However, Dr. Roth said, the new data are unlikely to be helpful. “The researchers have gone about this by looking at failure and this weakens the applicability and accuracy of the study. Rather than identifying factors that predict when you should extubate, they have looked at factors that tell you when you should not do so.

Table. Variables and Values Significantly Associated With Extubation Failure Patients Requiring Reintubation (n=379)

Minute ventilation, L/min

7.5±4

8.4±4

Respiratory rate, breaths/min

18±6

20±7

SpO2, %

99±2

98±2

Number of spontaneous breathing tests prior to extubation

2.4±2

3.4±3

PaO2 on arterial blood gas, mm Hg

143.9±56

126.5±45

Rapid shallow breathing index

35.1±24

41.4±44

Minute ventilation, L/min

7.4±3

8.6±3

Respiratory rate, breaths/min

18±6

20±6

SpO2, %

98.9±2

98.6±2

Heart rate, beats/min

90±19

92±18

Diastolic blood pressure, mm Hg

75±14

73± 6

Secretion frequency

6.6±4

8.4±4

Secretion quantity

9.0±7

12.2±8

38.4±14.9

43.7±15.9

Respiratory variables during spontaneous breathing trial

Respiratory variables immediately before extubation

Cardiovascular variables immediately before extubation

Upper airway parameters

Other

All P values ≤0.05.

0.05.

—David Wild Dr. Treggiari received research funding from the Anesthesia Patient Safety Foundation and Cook Medical Group; Drs. Roth and Nunnally reported no relevant financial conflicts.

Statement of Ownership

Patients Not Reintubated (n=1,628)

Simplified acute physiology score at ICU admission

Furthermore, the margins of error for the values they identified are very large and the values overlap significantly between the two groups.”

But Mark Nunnally, MD, associate professor of anesthesia and critical care at the University of Chicago Medical Center, said the findings, although retrospective, “confirm and supplement a lot that we know or suspect.

“It will be interesting to see how the authors might use these data to help make clinical decisions,” said Dr. Nunnally, y who was not involved in the research. “It is hard to reconcile population data with a patient in front of you, especially one for whom you are uncertain about success. Algorithms, such as the one proposed, are always challenging to create, but are worth exploring.”

NOVEMBER 2012

AnesthesiologyNews.com I 17

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

A Surgical Checklist for the Office Setting

A

checklist designed for an officebased plastic surgery practice improved documentation of key safety measures, researchers have found.

Despite being used routinely in many hospitals and ambulatory surgery centers, checklists have neither gained the same attention nor have been extensively tested in the office-based surgery settings, said coauthor Richard Urman, MD, MBA, staff anesthesiologist at Brigham and Women’s Hospital in Boston, who led the study.

“This is an area that has not been explored enough. There is a huge need, given all the safety concerns in officebased settings,” Dr. Urman said.

Dr. Urman and co-author Fred Shapiro, DO, staff anesthesiologist at Beth Israel Deaconess Medical Center, also in Boston, presented their findings at the 2012 annual meeting of the International Anesthesia Research Society (abstract NO S-03). Drs. Unman and Shapiro are the co-founders of the Institute for Safety in Office-Based Surgery, a Boston-based nonprofit group.

The researchers reviewed charts for 219 patients treated at the plastic surgery clinic to determine baseline rates for each checklist item, as well as various adverse outcomes of surgery. The baseline rate of adverse events was 15%, suggesting a need for the checklist approach, they said.

The researchers customized the list, based on the World Health Organization’s model checklist, after meeting with the practice’s surgeons, anesthesiologists and nurses.

“The prerequisite is that all members of the office, both medical and nonmedical, are willing to adapt the checklist to their setting,” said Dr. Shapiro, who has studied office-based anesthesia extensively.

Dr. Shapiro said it is equally important that staff understand the rationale for the various items in a checklist.

These might include the following: • Has the procedure complexity and sedation/analgesia been reviewed?

• Is the case-specific equipment available?

• What critical events are likely?

• Has a policy for emergency medical service (EMS) been confirmed on the day of the procedure?

• Are there concerns about local anesthetic toxicity?

• Have written instructions been given to the patient for postoperative medications, care and follow-up?

The increased anticipation of critical events demonstrates a subtle but important change in the operating room environment because improved communication and teamwork are critical for patient safety, Dr. Shapiro noted.

The researchers tallied prechecklist documentation rates for each item, as well as postsurgery adverse outcomes,

through a review of 219 charts. After an education program, the researchers performed a chart review.

At baseline, 90% of charts were missing documentation of three or more checklist items. The adverse event rate was 15%, and included cases of uncontrolled pain (3.7%) and bleeding/ bruising (3.2%). The measurable rate of adverse events “suggests potential

for improvement,” the researchers concluded.

After the introduction of the checklist, several key safety indicators and practices increased to 90% to 100%. These see checklist page 24

18 I AnesthesiologyNews.com

NOVEMBER 2012

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

Drug Trials Fail To Ease Postoperative Delirium

P

ostoperative delirium affects as many as two-thirds of patients over age 65 and increases inhospital mortality and health care costs. All of which makes the failure of researchers to find a treatment for the complication so frustrating.

Such is the fate of two recent efforts that showed promise in pilot studies but failed to pan out in subsequent Phase III clinical trials. Both trials involved already approved agents for common neurologic conditions.

In one trial, reported at Euroanaesthesia 2012 (7AP4-10), Alan Chaput, MD, an anesthesiology faculty member at the University of Ottawa in Canada, and his colleagues conducted a randomized double-blind, placebo-controlled study to see if the anticonvulsive pregabalin (Lyrica, Pfizer) could alleviate delirium in postoperative patients.

experience better sleep and had fewer side effects that related to their use of opioids, Dr. Chaput added.

The one statistically significant effect Dr. Chaput’s group found was that patients who received pregabalin required substantially less opioid medication than those who took a placebo.

But one expert said the trial may have been deeply flawed.

“Benzodiazepines and some other drugs are associated with delirium.

[The researchers] are not controlling the anesthetic,” said Keith Candiotti, MD, professor of clinical anesthesiology and chief of perioperative medicine at the University of Miami, in Florida.

“I’m afraid without controlling the anesthetic, they will simply end up with too many variables and not be able to reach

a conclusion. Finally, they simply may not have given pregabalin long enough preoperatively to reduce pain after surgery,” added Dr. Candiotti, a member of the editorial board of Anesthesiology News. Dr. Candiotti has served on the speakers’ bureau of Pfizer.

In another disappointing study, researchers at New York University Medical Center, in New York City,

‘My primary focus is on the triad of delirium, pain and sleep; we know that they all interact with one another. With one drug, we think there is a mechanism to target the delirium, target the pain and target the sleep.’

—Alan Chaput, MD The antidelirium effect from gabapentin was originally identified in a small pilot trial by Jaqueline Leung, MD, MPH, professor of anesthesia and perioperative care at the University of California, San Francisco of 21 patients (Neurology 2006;67:1251-1253). Dr. Chaput decided to follow up with a Phase III clinical trial.

The trial included 240 patients older than 65 who were scheduled to undergo major orthopedic or vascular surgery.

Half received 75 mg of pregabalin three times per day preoperatively and a lower dose (25 or 50 mg three times per day) postoperatively.

“We failed to show any differences at all,” Dr. Chaput said. “There was a trend when you looked at the daily data, but what looked like a trend was later found to be statistically insignificant. Patients who took pregabalin did

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NOVEMBER 2012

AnesthesiologyNews.com I 19

CL IN ICA L A N E STH E SIOL OG Y tested the drug rivastigmine (Elexon, Novartis), an anticholinesterase inhibitor approved to treat mild to moderate Alzheimer’s disease, in 28 surgery patients.

However, the drug failed to change the incidence of postoperative delirium, said Alex Bekker, MD, PhD, professor of anesthesiology and chair of anesthesiology at the New Jersey Medical School, in Newark, part of the University of Medicine and Dentistry of New Jersey.

However, the authors noted, “The

On Off

treated group had higher postoperative values [on cognitive tests], suggesting that rivastigmine may improve cognitive function postoperatively.”

Dr. Bekker’s group reported its findings in the International Journal of Geriatric Psychiatry (2012;9:986-988).

Dr. Bekker said that there is no definitive plan to follow up on the study for financial reasons. “It’s difficult to find companies [to sponsor],” he said. “They are not terribly interested in this [area].”

Rivastigmine was delivered as a patch, which patients seemed to tolerate well, he added. “This is a pilot and it looks like it’s the right direction,” Dr. Bekker said. “Conceptually it seems to make sense.”

Conversely, Dr. Chaput and colleagues will continue to pursue pregabalin as an antidelirium candidate.

In a spin-offf pilot study, two surgery patients who received pregabalin showed increased restorative stage 3 sleep patterns through brain

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monitoring—compared with five patients given a placebo—suggesting that sleep rather than pain may be a worthwhile target for delirium management.

“My primary focus is on the triad of delirium, pain and sleep; we know that they all interact with one another,” Dr. Chaput said. “With one drug, we think there is a mechanism to target the delirium, target the pain and target the sleep.”

—Trevor Stokes

20 I AnesthesiologyNews.com

NOVEMBER 2012

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

IV Lidocaine Useful for Ambulatory Surgery Patients

T

he use of intravenous lidocaine in patients undergoing outpatient g ynecologic laparoscopy improves the quality of recovery after surgery and reduces the need for opioids, according to a randomized, double-blind clinical trial.

Investigators at Northwestern University, who conducted the study, said clinicians should consider using IV

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lidocaine for a variety of ambulatory procedures.

“I would recommend that it [IV lidocaine] be used routinely in outpatient surgeries,” said Gildasio De Oliveira Jr., MD, assistant professor of anesthesiology at Northwestern University Feinberg School of Medicine, in Evanston, Ill., who helped conduct the research. “It should work

(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. ULTIVA 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 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 longterm (> 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 vivo 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 and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant

for surgeries that have the same pain profile.” Dr. De Oliveira’s group presented its findings at the 2012 annual meeting of the Society for Ambulatory Anesthesia (abstract E3) and published their results in Anesthesia and Analgesia (2012;115:262-267).

Although IV lidocaine has been shown to be effective at reducing postoperative pain in patients

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

Postoperative Analgesia

After Discontinuation

Adverse Event

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

ULTIVA (n=281)

Morphine (n=98)

ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

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 B, 06/08/2011 Manufactured for Bioniche Pharma USA LLC, Lake Forest, IL 60045 Manufactured by Hospira, Inc. Lake Forest IL 60045

undergoing inpatient surgeries such as colon resections, it is rarely used for outpatient surgeries. Before this clinical trial, the only study testing perioperative IV lidocaine in ambulatory surgery patients demonstrated that the drug reduced postoperative pain and opioid consumption in the postanesthesia care unit, but did not lead to a faster discharge from the hospital or reduce opioid consumption after discharge (Anesth Analg 2009;109:1805-1808).

In the new study, 63 healthy women undergoing outpatient gynecologic laparoscopic surgery at Northwestern Medical Center were randomized to receive IV lidocaine (a 1.5 mg/kg bolus followed by a 2 mg/kg per hour infusion) until the end of the procedure or the same volume of saline.

To measure patient outcomes, investigators used the 40-item quality of recovery score (Br J Anaesth 2000;84:11-15). This instrument measures several aspects of recovery, such as physical comfort, pain, physical independence and emotional well-being. Patients who received IV lidocaine had better scores than patients who received saline, with a median difference of 16 points (99% confidence interval [CI], 2-28 points; P=0.002). A 10-point difference is deemed to be a clinically relevant improvement.

Patients who received IV lidocaine also were discharged an average of 26 minutes sooner than those who received placebo (P=0.03) and required significantly less oral opioids after hospital discharge, with a median difference of 10 mg of oral morphine equivalents (P=0.01).

“Before this study, we knew that lidocaine improved postoperative pain in the inpatient population in the hospital, but we didn’t know if the improvement translated to a better recovery for patients,” Dr. De Oliveira told Anesthesiology News. “With this study, we actually now know that it improves pain in the outpatient population and the quality of recovery after surgery. When we used lidocaine for outpatient surgery, patients felt much better; they had less pain; they consumed less opioids; and they were able to be more independent on the day after surgery.”

Dr. De Oliveira said IV lidocaine is safe and could be useful for a variety of painful outpatient procedures. see lidocaine page 23

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AnesthesiologyNews.com I 21

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

Post-op Cognitive Changes Tied to Brain Anatomy

T

he cognitive decline that sometimes follows heart surgery may be associated with changes in brain anatomy and function, according to findings presented at the 2012 annual meeting of the Society for Cardiovascular Anesthesiologists ((Anesth Analgg 2012;114[suppl]:1-94).

Reviewing data collected from 11 patients who underwent cardiac surgery, Joseph Mathew, MD, chief of cardiothoracic anesthesiology at Duke Medical Center, in Durham, N.C., and his colleagues found that the patients exhibited edema in their white matter and less brain activity six weeks following the procedure. These changes were not seen in nine control patients with coronary artery disease who did not undergo surgery.

These findings help confirm that cognitive changes do, indeed, occur after surgery, Dr. Mathew w told Anesthesiology News. “Obviously, there is some disruption as a consequence of surgery, which is not seen in control patients,” he said. “There is something occurring during surgery that is resulting in an increase in cerebral edema and in how different areas of the brain are connected. Now, we can start to try to understand why it’s occurring, which will lead to ways to control it.”

His hypothesis is that some of the changes may be due to air emboli, which could be remedied by trying to eliminate any trapped air before separating the patient from bypass.

Although cognitive impairment typically is associated with cardiac surgery, researchers have reported the same phenomenon following other types

of surgery, said Gregory Crosby, MD, associate professor of anaesthesia at Harvard Medical School and Brigham and Women’s Hospital, both in Boston, who was not involved in the study.

The cognitive changes—usually in memory and attention—are not always permanent, Dr. Mathew said. “Typically, 50% of patients recover by one year” after surgery.

To investigate more fully the cognitive changes that happen after cardiac surgery, Dr. Mathew and his team administered five cognitive tests at baseline and six weeks later to patients who underwent cardiac surgery and similar nonsurgical patients. At both points, they also measured the integrity of participants’ white matter and brain function

using functional magnetic resonance imaging.

The researchers found that patients who underwent surgery were more likely to exhibit cerebral edema six weeks later, largely in the prefrontal cortex. The swelling also was associated with cognitive decline (correlation coefficient, 0.74). Moreover, the white see brain page 23

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22 I AnesthesiologyNews.com

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

SAMBA’s Registry Yields Initial Findings on Surgery Outcomes

T

he typical ambulatory surgical procedure runs 38 minutes, not including the 14 minutes between the time the patient enters the operating room and the first incision, according to preliminary findings from a new registry from the Society of Ambulatory Anesthesia (SAMBA).

Nearly all of the patients who required antibiotic prophylaxis received it within one hour before the incision: 92%, according to the study.

Patients spent an average of 45 minutes in the postanesthesia recovery unit before being discharged; however, the average time to discharge for patients who received spinal anesthetics was twice as long. The overall incidence of postoperative nausea and vomiting (PONV) for which antiemetic rescue was required was 4%.

Those findings are the first to emerge from SAMBA’s clinical outcomes registry (SCOR), created in 2010 to identify nationwide trends and promote quality in anesthesia

Samba Clinical Outcomes Registry Patient Database Form care for patients undergoing ASCs, both single and multispeBasic Info OR in (24h : mm) ambulatory procedures. Its develcialty, have become more prevaSurgery start (24h : mm) Preop opers hope to use the data they lent in the United States over the Surgery end (24h : mm) Intraop past gather to create benchmarks for few decades. According to OR out (24h : mm) PACU best practice for such surgeries, SAMBA, the percentage of surAdverse Events { General { Sedation { Neither which are becoming an increasing Follow-up Contact Anesthesia* gical procedures performed in an Temperature Management: part of the anesthesia workload. ambulatory setting in the United {Y{N Active warming in OR Gold: current section completed section States rose from 19% in 1996 to In addition to standard patient Silver: Patient temp at end of case Aqua: incomplete section (xx.x centigrade) information, the registry is a 65% in 2007. repository for data specific to Although a national anesthesia ambulatory events such as anesthetic “We’re in the growth phase at the outcomes database already exists—the technique, adverse events, physical moment,” explained Lucy Everett, Anesthesia Quality Institute (AQI)— status, pain control and PONV. MD, chief of pediatric anesthesia at the SCOR registry focuses specifically The SAMBA registry has been Massachusetts General Hospital, in on outcomes within the area of ambupopulated with data from members Boston, who is helping to build the latory care. The AQI and SAMBA are ranging from large academic med- registry. “We hope to have 100,000 collaborating to ensure uniformity of ical centers to small private prac- cases by this time next year.” data collection and to facilitate the tices. Approximately a dozen centers Further analysis showed that sharing of appropriate information. entered more 20,000 individual case patients undergoing tonsillectomy or The registry is web-based, so all a files into SCOR’s online system, pro- adenoidectomy were more prone to practice needs is a computer and an viding sufficient data to identify ini- emesis, with 11.1% experiencing post- Internet connection. Several ways to tial trends. The majority of data discharge vomiting and 15.6%, post- input the information exist; paper (80%) were provided by freestanding discharge nausea. Postoperative pain records can be transcribed into the and hospital ambulatory surgical cen- was somewhat more common, with system or input directly online by ters (ASCs), whereas office-based and 14% of patients saying their pain was computer, smartphone or electronic hospital out-treatment departments not “always well controlled,” accord- pen-based records. Users can downcomprised the remaining 20%. ing to the researchers. load their own data at any time and

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AnesthesiologyNews.com I 23

CL IN ICA L A N E STH E SIOL OG Y save it to a spreadsheet and also can compare them to national trends when they receive a quarterly report of aggregated data that has been deidentified to comply with federal privacy requirements.

“A lot of ASCs have no automated system, so this registry can serve them but for those who do, they don’t want to have to input information twice so SAMBA is working to enable linkages with other systems to avoid duplication,” Dr. Everett said.

The SCOR registry is primarily a member benefit, but nonmembers can pay a sliding fee to participate.

Mark Saxen, DDS, PhD, presidentelect of The American Society of Dentist Anesthesiologists, said that participation in SAMBA and SCOR is a natural fit for its members: “We follow the same essential clinical guidelines and recognize the importance of tracking outcomes for office-based anesthesia practice. Dentist anesthesiologists welcome the opportunity to participate in a registry that examines our results with the same assessment tools that are used to evaluate the broader community of all anesthesia providers.”

—Maureen Sullivan

LIDOCAINE

CONTINUED FROM PAGE 20

Robin Aldwinckle, MD, director of the Same Day Surgery Center at the University of California, Davis Medical Center, in Sacramento, said the trial was well conducted. “The quality outcome questionnaire that they have used has been validated for inpatients but not really for outpatients, but it seems the best tool that we have,” Dr. Aldwinckle said.

Dr. Aldwinckle added that the study breaks new ground. “This is the first study that has shown [that] lidocaine is useful for outpatients undergoing laparoscopic GYN surgery, as part of a multimodal analgesic strategy,” he said. “My only question would be how generalizable would it be for other groups of patients, given the fact that all patients in the study are female, and there are gender differences in how pain is perceived. The generalizability of the finding is going to be the question.”

—Kate O’Rourke Drs. De Oliveira and Aldwinckle reported no relevant financial conflicts of interest.

BRAIN

CONTINUED FROM PAGE 21

matter changes in surgical patients were accompanied by a significant decrease in brain activity, both relative to their baselines and to controls (P<0.01).

A unique aspect of the study, Dr. Crosbyy said, is that most previous reports have relied on neuropsychological testing to assess cognitive impairment after surgery, whereas Dr. Mathew w and his team

focused on structural and functional changes in the brain. “These researchers are moving in the right direction— using sophisticated brain imaging technology to look at a common problem in an interesting way,” he said.

However, the study was relatively small and the patients were relatively young (mean age, 63.9 years), he added, so it is premature to make any changes in practice based on these results. Furthermore, he said, it is unclear if the brain changes in these patients were

specific to cardiac surgery, or whether the same patients undergoing colon resection, for example, would have had these changes on neuroimaging. “This study does not prove these changes are unique to cardiac surgery,” Dr. Crosby added.

Dr. Mathew w and his colleagues are continuing to enroll patients in the study to determine if the same changes occur in a larger population of subjects.

—Alison McCook

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

Nearly 30% of ICU Deaths Have Missed Diagnoses

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misdiagnoses documented in the general hospital population in a previous 160 study (JAMA ( 2003;289:2849-2856).

The difference, Dr. Winters explained, 140 can be attributed to ICU-specific factors such the inability of patients to 120 communicate their medical history 100 during the workup process and limited staff resources leading to “competition 80 for care.” Factors not specific to the ICU, including an overload of infor60 mation and cognitive errors that lead to a biased interpretation of patient 40 data, also may play a role.

20 Richard Dutton, MD, executive director of the Anesthesia Qual0 ity Institute, in Park Ridge, Ill., who Vascular Infectious Mechanical/ Other specializes in trauma, said several obstructive (neoplasm, respiratory limitations may undermine the generdistress, etc.) alizability of the findings.

“Most autopsied patients have some Figure. The most common misdiagnoses in the intensive level of diagnostic uncertainty to care unit. begin with, which makes the populamajor diagnoses that would not have affected sur- tion in this meta-analysis not completely representavival or altered the course of care; and class III and tive of the general ICU population,” said Dr. Dutton, class IV errors as misdiagnoses related to the terminal who was not involved in the research.

Some of the studies included in the meta-analysis disease but not related to death or unrelated to both disease and death, respectively. were conducted before the introduction of more The rate of misdiagnoses detected during autopsy accurate and advanced imaging-based diagnostics, ranged from 5.5% to 100%, with a 28% overall Dr. Dutton noted. And he questioned the effect that rate (1,632 of 5,863), the researchers found. Class missed class I or class II diagnoses would have had I and class II errors accounted for 8% and 15% of on patient outcomes had they been identified. “If misdiagnoses, respectively; class III and class IV a patient is dying of septic shock, secondary events errors accounted for 15% and 21%, respectively. like myocardial infarction and pulmonary embolism, Dr. Winters noted that some studies reported only which are common during the immediate premortem the total number of misdiagnoses and class I or class period, may not have affected their survival.”

II errors, leaving the specific misdiagnoses of the —David Wild remaining 41% unclear.

The most common class I and class II misdiagnoses reported in the studies were vascular events Dr. Winters has received fees for expert testimony from several defense and plaintiff law firms, as well as honoraria from 3M and and infections.

The 8% rate of major and potentially lethal ICU various health systems. Dr. Dutton reported no relevant financial misdiagnoses is higher than the 5% rate of lethal conflicts.

180

Class I Errors Class II Errors

Number of Misdiagnoses

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s many as 28% of adult patients in intensive care each year die with a misdiagnosis, and up to 8% die with a potentially fatal “major missed diagnosis,” such as pulmonary embolism or myocardial infarction, researchers have found.

The findings, from a meta-analysis of 31 autopsybased studies (BMJ Qual Saff 2012; doi:10.1136/ bmjqs-2012-000803), may even understate the rate of missed diagnoses, said Bradford Winters, MD, PhD, associate professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, in Baltimore, who led the research. ”Since we did not include non–autopsy-based studies in our analysis, we did not evaluate misdiagnoses that did not result in death, but that are likely associated with increased morbidity health care costs,” Dr. Winters told Anesthesiology News.

The 31 studies—which were observational, mostly retrospective studies and largely based in the United States—included information from 5,863 autopsied adults who had died in an intensive care unit (ICU).

The papers were published between 1966 and 2011.

The analysis excluded publications that examined the rate of disease-specific misdiagnoses and studies that did not include original data. A median of 43% of ICU deaths that occurred during the study period were autopsied.

The investigators turned to the Goldman Classification, widely used for autopsy findings, to group the misdiagnoses they identified. The criteria define class I errors as “missed major misdiagnoses with potential adverse impact on survival and that would have changed management”; class II errors as missed

CHECKLIST

CONTINUED FROM PAGE 17

included the presence of case-specific equipment, confirmation of EMS policy and precautions for local anesthetic toxicity.

Use of the checklist also resulted in improvement of surgical site and side markings and the discussion of patient preparation and critical events, which “demonstrate an important change in the operating room environment because improved communication and teamwork are critical to any patient safety endeavor,” according to the researchers.

John A. Dilger, MD, president of the Society for Ambulatory Anesthesia, noted that even in hospitals, where standards of practice are in place and should be followed, items may be missed.

“The checklist may be even more important in an office setting where Joint Commission standards

may not be in place,” said Dr. Dilger, assistant professor of anesthesiology at Mayo Clinic, in Rochester, Minn.

The checklist is a good idea, he said, but added that the study does not measure whether missed and unchecked items led to an increase in near misses or morbidity.

Dr. Shapiro said the goal of this study was to determine if the checklist increased the documentation of the use of quality and safety indicators.

Larger, prospective studies will be needed to determine if the list improves mortality and morbidity and reduces cost. The researchers also plan to adapt the checklist for other specialties, including interventional radiology, podiatry and dentistry.

—Tinker Ready

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AnesthesiologyNews.com I 27

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New York City hospital has significantly reduced delays for first-case surgeries by sending attending surgeons email reminders to arrive in the operating room early. Under the system, the share of first cases that started on time rose from 25% to 85%, according to the researchers. The group presented its findings at the 2012 World Congress of Anesthesia (abstract 15).

Project lead Maria Fezza, BSN, RN, nurse manager in Peri-Operative Surgical Services at the NYU Langone Medical Center, and Jung Kim, MD, chief of service in the Department of Anesthesiology, and medical director of Peri-Operative Surgical Services, cited research showing 15-minute delays in first cases can lead to backlogs of up to 1.5 hours by the end of the day (CMA 2006;29:S83-S88). After noticing most of their first cases began late, they formed an “On-Time Start Committee,” headed by the surgeonin-chief,f tackling what they observed as the primary reason for these delays: surgeon tardiness.

In February 2010, the group began routinely emailing their attendings, asking them to arrive 20 minutes prior to the scheduled procedure start time.

Within one month of introducing the intervention, the number of first cases starting on time jumped to 76% compared with 27% during the same month in 2009 (Figure). The number of on-time first cases continued to rise to 85% after three months of email

reminders, the researchers said.

Since presenting their data, the researchers have found the on-time rate has dipped back down for a variety of reasons they are investigating. However, it remains above 62%.

Ms. Fezza, who writes and sends the reminders on a daily basis, said existing delays are now shorter than they had been in the past. The committee can further increase the rate of on-time first-case starts, she said.

“With continued support from top leadership, continuing observations and data collection, we can keep reducing delays,” she said.

Dr. Kim said the efficacy of the simple intervention may have been a function of the surgeon-inchief ’s involvement in the project. “We don’t know whether the improvements were a result of the daily reminders themselves or the fact that the reminders were coming from a person with significant authority,” he said. “The results may be different at an institution where the surgeon-in-chieff has less authority.”

Franklin Dexter, MD, PhD, director of management consulting in the Department of Anesthesia at the University of Iowa Carver College of Medicine, in Iowa City, agreed the reminders were effective in addressing delayed first-case starts at NYU Langone.

But Dr. Dexter, who was not involved in the study, said tackling delays is not necessarily the best way to increase operating room efficiency.

First Cases in OR on Time, %

Email Reminders Reduce First-Case Surgery Delays 90 80 70 60 50 40 30 20 10 0

2010 2009

January February

March

April

May

June

Figure. First-case on-time starts.

“First-case delays generally do not lead to delays in subsequent cases,” Dr. Dexter said. “Addressing tardiness with email or text reminders would be a good intervention if a surgeon routinely has 10-hourr days of procedures. But in situations where the surgeon routinely has a caseload of six or seven hours, and this is due to insufficient referrals, even if the surgeon regularly arrives late, addressing their lateness would not make a difference. In this case, I would suggest taking advantage of the fact that their operating room is not entirely full and start the surgeon’s cases after that of a surgeon with a full day.”

—David Wild

Rise of Surgicenters Shifts Patient Populations for Hospitals

T

he growing number of walkin surgical centers has led to a redistribution of patient populations, with hospitals absorbing more acute cases, researchers have found.

The findings, from a single center over more than a decade, “document what the ambulatory community has long thought or personally observed,

Ophthalmology, 19%

namely that surgical centers tend to shift healthier patients away from the hospital,” said Michael Walsh, MD, assistant professor of anesthesiology at Mayo Clinic in Rochester, Minn.

The number of free-standingg ambulatory surgery centers (ASCs) in the United States has risen from about 5% of all outpatient facilities in 1982 to

Pain Management, 8% Dermatology, 4% Orthopedics, 7% Other, 8%

Gastrointestinal, 24%

Mixed or Multiple Specialty, 34%

Urology, 2%

Otorhinolaryngology, 1% Obstetrics, >1% Vascular, >1% General Surgery, >1% Pulmonary, >1%

Figure. Percentages off ASCs SC by specialty.

Sou ce Ambulatory Source: bu ato y Su Surgery ge y Ce Center te Association ssoc at o

nearly 40% in 2005, according to the Ambulatory Surgery Center Association, a trade group (Figure).

Dr. Walsh, who was not involved in the study, said it confirms that ASCs have accomplished their goal of easing the patient burden on the hospital system. “This analysis demonstrates the importance of matching the correct patient, procedure and venue,” Dr. Walsh said. “It would be interesting to see if the duration and complexity of cases has also been increasing in the hospital setting during this time period, as one might logically expect.”

The researchers presented their findings at the 2012 annual meeting of the Society for Technology in Anesthesia (abstract 7). Mohamed Rehman, MD, and his colleagues analyzed a database from the Department of Anesthesiology and Critical Care Medicine at the University of Pennsylvania School of Medicine in Philadelphia, where Dr. Rehman is clinical associate professor of pediatrics. The data included medical records, including American Society of Anesthesiologists (ASA) Physical Status scores, from approximately 2.75 million

surgical patients treated between 2000 and 2011.

Dr. Rehman’s team found that during the study period, the number of ASA class 1 patients treated in their hospital steadily decreased while the proportion of class 2 and 3 patients rose. ASA class 1 patients comprised 34% of all cases in 2000, but only 18% in 2011.

Similarly, class 2 patients accounted for 36% of cases in 2000, but 44% in 2011.

Twentyy five percent of patients in 2000 were ASA class 3, a figure that rose to 35.8% in 2011. The change in the proportion of ASA class 4, 5 and 6 patients over the same period was negligible, Dr. Rehman found.

Although the study did not look at shifts in the patient populations at nearby ASCs, Dr. Rehman said he suspects the share of healthier patients receiving treatment in the ambulatory setting has increased.

“Nevertheless, factors other than the presence of ASCs might have affected the change we’ve seen at our hospital,” Dr. Rehman said. “These possibly include variability in the interpretation see ASCs page 29

28 I AnesthesiologyNews.com

NOVEMBER 2012

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computerized decision-making tool that considers evidencebased medicine plus factors like social, legal and ethical concerns is helping one Canadian hospital make decisions about which perioperative drugs to stock in their formulary.

The program, called Know4Go, was designed about four years ago by Janet Martin, PharmD, who has a master’s

in health technologies assessment, at London Health Sciences Centre University Hospital, affiliated with the University of Western Ontario.

Know4Go incorporates a mathematical formula calculating the impact not only of evidence-based medicine but also of factors she calls SLEEPERs— the social, legal, environmental, ethical, political, entrepreneurial, research

and stickiness/reversibility issues that often are to blame when someone or something goes against evidencebased medicine when making formulary decisions.

The analytical tool is designed as a graph, with budget impact (the cost of a new drug or device per patient in their setting) along the y axis and the benefit impact (the number of

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eligible patients divided by the number needed to treat to prevent a bad outcome) along the x axis. The results help make apparent whether formulary decisions should be a ‘go’ or a ‘no-go’ relative to the next best alternative.

In a recent study, Dr. Martin and colleagues identified high-stakes perioperative drugs for review based on their likely clinical, economic and risk impact. They used Know4Go to calculate the benefit index based on local patient characteristics and number likely to be helped or harmed; estimate local budget impact; perform a SLEEPERs assessment; and make informed decisions.

Dr. Martin and her colleagues have used the program to evaluate more than $6 million of drug therapies at their hospital, according to an abstract presented at the recent World Congress of Anaesthesiologists (abstract 834.00). The program helped them reverse a trend from rising drug costs in the two years before Know4Go was implemented to a steep decline after implementation, with an estimated savings of $1.1 million both from preventing the uptake of some expensive drugs and from eliminating orders of medications that were no longer helpful.

“Once something is in practice, it’s much harder to take it out instead of preventing it in the first place,” Dr. Martin said. “When making decisions, we have to make trade-offs and decide what we’re going to do and not do, recognizing we can’t do it all or all at one time. Know4Go ensures we take the opportunities with the maximum benefit.”

NOVEMBER 2012

AnesthesiologyNews.com I 29

PR N The program has improved staff collaboration and reduced confusion between contrary evidence and opinions, Dr. Martin said. In addition, “when we put a decision on the table, if we say no, it’s not that the decision is permanently no, it’s just not right at this time, so that has made things more comfortable.”

Interest Piqued Several hospitals have approached Dr. Martin about using Know4Go. She has started working on a new version of the program that could be adopted by other facilities. She also has been using Know4Go to evaluate whether the hospital should adopt other health technologies.

John Poikonen, PharmD, director of clinical informatics at the University of Massachusetts Memorial Medical Center in Worcester, called the technology “pretty cool and interesting” but said the process for evaluation would have to be made evident to stakeholders because “sometimes there is an overreliance on local opinion and culture over medical evidence.” Added Dr. Poikonen, “I’m excited to see this in the public domain or as an open-source product for people to use and adapt.”

—Karen Blum

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ASCS

CONTINUED FROM PAGE 27

and assignment of ASA classification, an overall sicker general population or an increase in patients who have deferred their medical and surgical care until later in the disease processes due to socioeconomic or other factors.”

According to the researcher, a sicker hospital patient population has potential—if minor—implications for clinicians. Trainees who

work solely in hospitals and do not rotate in ambulatory settings may be underexposed to simpler “bread-andbutter” procedures conducted in the healthier ASC patient population, he said.

Dr. Rehman’s team is now examining the possibility that morbidity and mortality rates have increased in the hospital setting along with the preponderance of sicker patients.

“We’d like to get a good picture of what the outcomes are, in light of a

sicker population, and whether we can intervene to reduce negative outcomes,” he said. “Generally, it is difficult to assess morbidity and mortality in anesthesiology because the rates of these are so low, so you need a large population to detect any patterns.

Since we have one of the largest anesthesiology databases in the country, we are in a good position to examine this question.”

—David Wild

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NOVEMBER 2012

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CONTINUED FROM PAGE 1

The commission, which has six members, also will work to promote cooperation among the many players funding studies in the region, including the federal government, the state of Alaska, industry and other countries. Dr. Zapol spends up to three weeks a year traveling to the Arctic and about twice that long on Above: “I swear that squid was this big!” phone calls, writing and other Dr. Zapol tells a fish tale to a troop of Emperor commission work. penguins during a trip to Antarctica.

The health challenges in the Arctic are uniquely related to its phys- Right: A Weddell seal. ical environment, Dr. Zapol said.

Helping the indigenous popuThey run the gamut from the fundamental—access to fresh water, waste disposal—to complex psychological lation deal with its problems takes cultural sensitivity. issues such as alcoholism, depression, violence and sui- “How we’ve treated native populations in our country cide. Common medical problems like obesity, diabetes and how they’ve responded is a very tender spot in our and cancer also are on the rise among Arctic residents. history,” Dr. Zapoll said. “It’s easier to save blue babies Other pressing problems include the financial and from dying.” psychological effects of rapid Arctic warming and But even a more clear-cut problem like the provichanges in the sea ice habitat, as well as lack of access sion of water is complicated in the Arctic. Nearly oneto advanced medical and psychiatric services in small fourth of rural households in Alaska lack in-home villages. Alaska has the most expensive health care per water and sanitation services, the highest share in the capita in the country, Dr. Zapol said. Despite having nation. As a result, residents chronically suffer severe an area one-third the size of the continental United health problems such as respiratory hospitalizations, States, Alaska has no medical school. skin infections, invasive bacterial infections and denDr. Zapol said a particular difficulty is the treat- tal caries, according to USARC’s Report on Goals and ment of mental disorders. “The challenge of provid- Objectives for Arctic Research 2011-2012. ing psychological help to scattered, isolated village “Alaska is the only place in the United States you populations is compounded by the fact that I don’t can do a study of the effects of hand washing on believe there are a dozen psychiatrists in Alaska prac- respiratory infection because of villages with little ticing outside the major cities,” he said. water,” Dr. Zapol said. “I’ve worked hard on getting water to unserved village homes. At first you think, ‘Why can’t the state do that?’ But you learn it’s very, very expensive and there isn’t enough money in the Advertisement state of Alaska.”

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in the treatment that are widely used today. Inhaled nitric oxide is now used to treat approximately 30,000 patients per year in the United States as a vasodilator for pulmonary circulation and to augment arterial oxygenation, according to Mass General.

His current projects include looking at the effects of age on blood cells and trying to make heme-basedd oxygen carriers safe and effective for emergency transfusion in the field.

Jeanine Wiener-Kronish, MD, anesthetist-in-chief at Mass General, praised Dr. Zapoll for his long history of innovation in translational medicine: “There are very few people who are this active throughout their careers, still taking on new opportunities and new challenges.”

But not all of Dr. Zapol’s research has clinical application. Indeed, it was a side project from the opposite end of the planet that eventually led to his position on the USARC. Through nine expeditions to the Antarctic from 1975 to 1993, Dr. Zapoll studied the Weddell seal to understand how the mammal could dive to depths as great as 500 meters and remain submerged for more than an hour. The multidisciplinary group he brought together drilled holes in the sea ice, caught seals, examined them for pregnancy and attached novel microcomputers of their own design to measure physiologic data and obtain blood samples while the animals swam freely beneath the ice sheet.

His interest in the region led to new roles, first as a member of the Polar Research Board of the National Academy of Sciences and then with the Arctic commission.

Practical Problem Solver Fran Ulmer, USARC chair, said she was “thrilled” This pragmatic approach is trademark Zapol, who about Dr. Zapol’s reappointment to the commission learned to apply laboratory innovations to fix human and said he was a “big asset” to its work.

“He brings a great deal of experience and knowlproblems as a young scientist at the National Institutes of Health in the late 1960s. Working with edge to our commission. He knows a lot about health mentor Theodor Kolobow, MD, he helped make and a lot about both the Antarctic and the Arctic,” membranes, catheters and other devices—at one Ms. Ulmerr said. “His ability to connect us with other point melting down lingerie in order to obtain the professional people on the East Coast—those who right materials—while developing an artificial lung have done a lot of health research and those who have that would relieve the acutely injured lung of the done a lot of research in challenging conditions in the burden of gas transport. The researchers performed Arctic and Antarctic regions—help us to better define some of the first perfusions with extracorporeal what we do as a commission in the Arctic. He brings a membrane oxygenation (ECMO) for acute respira- passion on health issues that really connects with the tory distress syndrome in adults and infants. people who live in Alaska and who experience some of Dr. Zapoll went on to conduct in-depth research on the special challenges associated with cold, dark chalECMO, beginning in his residency at Mass General, in lenging environmental conditions.” studies that helped shape many of the best practices —Jennifer Hanawald

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NOVEMBER 2012

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Tablet-Based Technology Gauges Surgical Blood Loss Developers tout algorithm as way to reduce transfusions

A

n optical scanner for Apple’s iPad tablet computer reliably estimates blood loss during surgery, according to a pilot study evaluating the technology in both experimental and clinical settings.

More precise measurement of blood loss during surgery could provide better information to maintain hemodynamic stability of the patient and to help anesthesiologists determine, in real time, if and when to start a transfusion, Siddarth Satish, MS, a chemical engineer, and his colleagues reported at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 809).

“Blood loss estimation during surgery has been an enigma, and is subject to a best guess and negotiation between the surgeon and the anesthesiologist,” Mr. Satish told Anesthesiology News.

The scanning algorithm tended to underestimate surgical blood loss compared with postoperative gravimetric

measures. In contrast, staff using standard visualization tended to overestimate blood loss compared with gravimetric calculations based on weight differences between bloodsoaked and dry gauze pads.

“Our technology is aimed at quantifying blood loss to a high degree of accuracy and precision in real time so that this information can proactively lend clarity to the clinical picture, rather than vice versa,” said Mr. Satish, a researcher at Stanford University School of Medicine in California when he helped develop the algorithm.

“Weighing blood-soaked sponges is thought to be accurate, but timeconsumingg and often not feasible for already overworked nursing staff,” said Mark J. Rice, MD, chief of liver transplantation and general surgery in the Department of Anesthesiology at the University of Florida College of Medicine, in Gainesville. “Satish and his colleagues, using digital technology, have

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created an innovative, rapid, and what appears to be accurate alternative to our current approach.”

An inability to weigh only blood in the gauze—and exclude saline and other fluids that could have increased the weight—was a limitation of the study. The iPad scanning strategy obviates this potential concern.

“Although it would need to be validated by a more comprehensive study, the authors hint that this might even be more accurate compared to weight-based techniques by quantifying only blood and disregarding confounding fluids,” said Dr. Rice, who was not involved in the new research.

In addition, the objective scan technology produced less variability than standard human visual estimates. The scan technology performed particularly well with high volumes of blood.

“We have also designed the platform to be extremely easy to use and intuitive so that it fits seamlessly into the workflow of a surgical procedure,” Mr. Satish said.

In initial testing, the researchers mounted an iPhone4 (Apple) a mean of 16.5 cm above the surface of standard surgical sponges splattered with outdated human blood. The visible color data from the phone’s pixel sensor were used to calibrate the algorithm. There are no plans currently for an Android version of the technology.

The researchers then moved to the clinical setting and used an iPad to scan gauze pads collected from operating rooms at Stanford and the Lucille Packard Children’s Hospital. Mr. Satish and his colleagues compared the scan technology performance with actual blood loss calculated gravimetrically.

So, does the algorithm lead clinicians to withhold transfusions, while the weight method leads to overtransfusion? The answer, Mr. Satish said, is complicated.

“First, the actual transfusion decision is always up to the anesthesiologist making the call, and their assessment is critical. Estimated blood loss is one critical metric that, along with other hemodynamic parameters and patient

variables, provides them with a clinical picture via which they can make a transfusion decision,” he said. “Having this as an accurate number as opposed to a random guess is categorically beneficial—especially in situations with high blood loss.

“Technology can add value the most to clinical care when it is specifically designed with the user in mind,” he continued. “With the iPad, we’ve placed special emphasis on building an intuitive interface that not only displays highly accurate data, but also provides anesthesiologists with a seamless user experience.”

Mr. Satish’s group has revalidated their algorithm using spectrophotometry of the contents of sponges and suction canisters. “The results demonstrate both a high level of true accuracy by the algorithm as well as the significant overestimation by the weight method,” he said.

Mr. Satish is now founder and chief technology officer at Gauss Surgical, Inc., a startup company designed to further refine and market the technology. “We have received two FDA 510(k) clearances to date on key parts of our platform and demonstrated great clinical results in studies performed at a major cancer surgery center, a tertiary medical center and a community hospital’s ORs,” he said.

“We are hoping to see the product in clinical use in late 2012 or early 2013.”

—Damian McNamara

NOVEMBER 2012

AnesthesiologyNews.com I 33

CL A SSIF IE D S Anesthesiologist sought for busy ASC in Cherry Hill, N.J.

Be a part of a superior, professional team of specialized physicians, nurse practitioners, registered nurses, and experienced and dedicated medical, counseling, and administrative support staff. We are seeking full-time or part-time day coverage for our abortion surgery practice Tuesdays through Saturdays, daytime only, no night call.

Cherry Hill Women’s Center (CHWC) is nationally recognized as a model of excellence in women’s health and abortion care in the first and second trimesters, and has offered services for more than 30 years. CHWC is accredited by the National Abortion Federation, is AAASC-certified, and is a member of the AAAASF. Candidates must have a N.J. medical license, board certification, DEA, CDS, PALS/ACLS.

Interested parties should contact Elaina Nordo, Administrator, at enordo@cherryhillwomenscenter.com; fax (856) 356-4039 or phone (215) 694-6821.

AN-1012-001

Clinical or Basic Science Faculty Position, Research Anesthesiologist The Department of Anesthesiology at Penn State Hershey College of Medicine is seeking an experienced, Anesthesiology Board Certified, Clinical or Basic Science Research Faculty member to join a growing Anesthesiology Research Department.

The applicant will be a clinical anesthesiologist, preferably at the Associate or Full Professor level, who has demonstrable ongoing research productivity.

The candidate will receive suitable seed funding, commensurate academic time as well as the necessary facilities to pursue research interests.

The successful candidate will be assigned a named Professorial Endowment for the first three years as a Faculty member in the Department.

Interested applicants should submit their CV and cover letter outlining their research interests to: Dr. Berend Mets, MB, ChB, PhD, FRCA, FFA (SA) Eric A. Walker Professor and Chair, Department of Anesthesiology Penn State Milton S. Hershey Medical Center/ Penn State College of Medicine P.O. Box 850, M.C. H187 500 University Drive Hershey, PA 17033-0850 bmets@hmc.psu.edu Applicants can visit: www.pennstatehershey.org/anesthesia to learn more about the Department.

Penn State is committed to affirmative action, equal opportunity, and the diversity of its workforce.

AN-1012-006

AN-0112-001.PDF

We’re in a

position to fill your

position For classified advertising: contact Alina Dasgupta 212-957-5300 x338 adasgupta@mcmahonmed.com

(215) 955-7196 • suzanne.mccade@jefferson.edu www.jefferson.edu/jmc/anesthesiology/education/cme.cfm

34 I AnesthesiologyNews.com

NOVEMBER 2012

C OMM E NT A R Y

Looking at the Mountain

G

rowing up in New York City with its high pulse and 24/7 lifestyle, I always looked forward to the family tradition of summering in the idyllic Adirondack Mountains. The tranquility of looking out from the deck at the mist over Mirror Lake and at the mountains with their many changing colors of the seasons has always cleared my soul. As my professional life has become more complex with constant patient care issues, administrative duties and academic deadlines, I have always looked forward to the distraction-free cocoon of nature. I have always returned feeling cleansed, rested and ready to pick up the many pressures and challenges of modern medical practice.

But lately I have noticed an unsettling—and ironic—change. In the past few years, my research and teaching has concentrated on the topic of electronic distraction in professional practice, and in particular how personal electronic devices have weakened our ability to focus on patient care. In my view, the proliferation of digital technology in the hospital has done tangible and significant damage to the way physicians interact with patients.

Now, it seems, the focus of my professional life is threatening to consume my time away from the office. This summer while on the family holiday in Lake Placid, I received more than 1,000 workk related emails and texts. My co-workers and colleagues throughout the world evidently were unable to understand the message on my email system, “Dr. Papadakos is on vacation in the Adirondacks and has limited Internet access.” The majority of people and organizations in my life for some reason needed an immediate response. Many of them sent followup emails asking me to respond at once. Some called to verify that I had received their all-important email about a meeting two months in the future. The hyper-social need for responses is now pervasive in all forms of communication.

This obsession that we need to be “in touch” and work without rest troubles me deeply. Many of us remember the endless debates in the lay press about the work hours of residents. Back then, physicians needed rest! This debate predates the technologyfilled world of smartphones and tablets. What do we do in our new technological world that we and

our residents are required to respond to emails, check electronic medical records for lab results and reports, and field texted questions? The busi- Peter J. Papadakos, MD ness literature is increasingly populated with articles demonstrating that pressure to work “around the clock” and on off days leads not to corporate nirvana but to fatigue and lower productivity. There is no reason to believe that health care professionals, whose lives are at least as stressful, if not more so, than those of their colleagues in the business world, would be any less prone to burnout.

This constant electronic work also will affect the dynamics of the work force and may push senior staff to the point of quitting or substantially scaling back their workload.

The never-endingg fatigue also may lead to irritability—a well-documented phenomenon in the business world—and a lack of focus that may affect both social interactions and patient safety.

Constant emailing and texting is not a replacement for real human interaction. At the same time, neither is it unobtrusive or, to coopt a term from the operating room, noninvasive. As professionals, we need to recognize that we all need time away from our many work-related duties. Many industries have already decreased offf hour and vacation communications with staff. We in health care must educate our hospitals and departments to follow this lead and limit emails and communications after hours and on holidays. Staff should be removed from automated email deliveries when on vacation. We all need time away to sit and look at the mountains. So turn off your phone, refrain from checking email and read a good book on the shore of your own Mirror Lake. You and your family are on vacation.

—Peter J. Papadakos, MD Dr. Papadakos is professor of anesthesiology, surgery and neurosurgery at the University of Rochester, in Rochester, N.Y., and a member of the editorial board of Anesthesiology News.

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