The May 2013 Digital Edition of Anesthesiology News by McMahon Group

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THE IN NDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • M a y 2 0 1 3 • Volume 39 Number 5

Klebsiella a Now Reigning Superbug

Another Benefit of Daily Aspirin: Better Outcomes After Trauma

ospital pharmacists face several challenges in helping manage antibiotic-resistant, gram-negative superbugs that produce carbapenemases. One of the most worrisome is carbapenemase-producing Klebsiella pneumoniae (KPC). A report in the March issue of Infection Control and Hospital Epidemiology (2013;34:259-268) found that the proportion pr of K. pneumoniae caases resistant to carbapenems increased from 0.1% in 2001 to 4.5% in 2010. “That is huge,” said Robert Rapp, PharmD, emeritus professor of pharmacy and surgery at the University of Kentucky U

rauma patients with severe injuriees appear to have a better prognoo sis if they have been taking aspirin n or other antiplatelet drugs before being injured, researchers have found. The study found that trauma patientss at high risk for death were much less likely to develop transfusion-associated lung dysfunction or organ failure if they had been taking antiplatelet agents before being injured compared with others not on antiplatelet therapy. The findings, reported in the Febru-ary 2013 issue of Critical Care Medicine (2013;41:399-404), support a growin ng body of evidence implicating plateletts in

see superbugs page 22

see aspirin pag ge 32

Breathing for Two: a Life in Anesthesiology y The following is the second in a threepartt installment of excerpts from Breathing for Two, o a new memoir on a career in anesthesiology, by Wolf Pascoe (a pen name). The book is available at http://www.amazon.com/ dp/1939803012 and wolfpascoe.com.

INSIDE

20 | PRN

actual amphitheaters in those days, with rounded tiers of seating for medical students, rising away from a central stage. Ether, “sweet vitriol,” is a liquid at room temperature. It boils at 94 degrees Fahrenheit, turning easily to gas. A potent bronchodilator, he modern era of surgery— it had been used for hundreds of years to treat respiratory ailments. indeed, of medicine—may be said to have arrived precisely at 10:15 in Many physicians and scientists had studied ether, the morning on Friday, October 16, 1846, with Mor- including Sir Isaac Newton, who set it aside as an ton’s public demonstration of ether anesthesia. The uninteresting compound. By the nineteenth cenoperation took place in the surgical theater of Massa- tury, it was used chiefly by students for ether frolics. chusetts General Hospital, recognized from that time A quantity of ether was passed among the guests at forward as the Ether Dome. Operating rooms were see breathing page 10

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08 | COMMENTARY Older anesthesiologists: out of gas or simply road-tested?

17 | PAIN MEDICINE Feds see REMS programs falling short. Steven Zeitels, MD, airway surgeon to the stars.

30 | CLINICAL ANESTHESIOLOGY A vitamin for the lungs.

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Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First:

May 2013

The five most-viewed articles last month h on AnesthesiologyNews.com 1. Sugammadex Speeds Obesity Surgery, Study Finds (Web Exclusive) 2. Focus on Anemia May Alter Transfusion Practices 3. Doctor Group Claims Drug Purchasing Organizations Causing Chronic Shortages 4. Anesthesia Illustrated Tests Open-Source Education Model 5. “Hybrid” Pre-Op Assessment Model Increases OR Efficiency at Nebraska Hospital

We need to reexamine ‘stage II on emergence’ and find evidence for its existence or

move beyond stage II toward improving quality of extubation and emergence by focusing on factors that we have evidence for. SEE ARTICLE ON PAGE 45.

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C OR R E SP O NDENCE

Near Misses and Snacking Patients To the Editors:

If it doesn’t, I think that it mayy certainlyy put lawyyers, who represent patients harmed bby opioid analgesics, on notice of what theey should look for in and the standard of care they will be asking courts to measuure health w care providers against.

he recent article, “Near-Miss Data Show Signs of Trouble Outside OR”” (March 2013, page 1) outlines the causative mechanisms associated with near misses in non–operating room situations. The increase in near misses underscores the necessity for increased safety measures. As the provision of anesthesia outside the operp ating room increases in freqquency, hospitals need to ensure safety strategies are extended be yond the operating room as weell. In 2012, the Joint Comm mission issued Sentinel Event Alert 49 on safe use of opioids in hospitals, whicch underscores the associatioon of adverse events with use of opioid analgesics. In particular, the Sentinel Event Alert highlights some of the causes for opioid-related adverse events: lack of knowledge about opioid potency, improper prescribing and administration, and inadequate patient monitoring. These causative issues are consistent with many of the mechanisms uncovered by Dr. [Angela] Lipshutz and her team that indicate that the majority could be fixed by hospitals. However, more importantly, if these causes can be fixed, this leaves open the larger question of the liability of hospitals that know and do not fix. For example, in the Sentinel Event Alert, the Joint Commission cautioned against relying on pulse oximetry alone when it stated, “Staff should be educated not to rely upon pulse oximetry alone because pulse oximetry can suggest oxygen

—Michael Wong, JD Mr. Wong is executive direector of the Physician-Patient Alliance for Health & Safety.

saturation in patients who are actively experiencing respiratory depression ... .” Clinicians need to monitor patients outside of the operating room for hypoxia and hypoventilation to mitigate the risk for respiratory arrest induced by opioid analgesics. In the checklist we recently released, which can be downloaded for free from our website (www.ppahs.org), one recommended step is to electronically monitor patients with both pulse oximetry and capnography. Many of the causative mechanisms uncovered by Dr. Lipshutz and her colleagues are within the control of hospitals. Does this study and the Joint Commission’s Sentinel Event Alert put hospitals and anesthesiologists and other health care providers and staff who work in them on notice of the issues they should know and fix?

To the Editors: he article “Saying No to NPO” (March 2013, page 38) describes how carb drinks may improve the surgical experience of patients who would otherwise suffer from being NPO from midnight for their afternoon procedure. What the story does not mention is the noncompliant patient who eats a late, full breakfast or snacks at noon. It takes only one or two patients who do not comply to cause disarray in the surgical schedule. The result is an inconvenience to the patient and his or her family, and to the surgeon, not to mention the associated costs of a cancelled case.

—Marc Reichel, MD Dr. Reichel is a partner in a private anesthesiology group in Beaufort, S.C.

Chronic Post-op Pain: A Clinician/Patient’s Perspective

s an anesthesiologist who is currently debilitated and who has been unable to carry out my practice for the past three years because of complications from chronic postoperative pain, I feel compelled to share my thoughts on the February 2013 article “Chronic Post-op Pain Takes Toll on Patients, Resources” (page 10). The authors present statistics showing that such pain disorders outnumber the incidence of diseases in the forefront of medical attention, such as breast cancer. Thus, it should strike us all that this area of discussion is long past due. Although I am delighted to see an article that addresses this highly overlooked and significant issue, I would like to note several points unmentioned in the story. I understand the primary focus and financial drive of our modern

practice model. However, I am left wondering if we might someday feature an article titled “Chronic Post-op Pain Takes Toll on Patients.” Although pain management deals with a diverse array of complex issues, I have been startled to find myself on the other end as a patient and the frank lack of dignity this population must endure. Certain psychosocial issues may play a role in the care of pain patients, but our stereotype of the prevalence of psychological factors is highly outdated. Pain as a subjective experience, without any means of quantification, should not lump all patients together as having underlying psychiatric diagnoses. This is not to say that lack of appropriate diagnostic codes to protect us from the scrutiny of insurance carriers is completely without cause, but it continues to define and limit our access to care.

Through my personal struggle with adhesion-related disease, I have endured extensive specialty consultation in an attempt to evaluate—or, more appropriately, to “document”— my condition and limitations. I am familiar with the blank stares from medical professionals but am fortunate to have the educational capacity to help myself. What does work is focusing on what you can do rather than what you can’t, regardless of the ongoing medical focus dictated by an insurance-driven industry. Patients are more resourceful than we often give them credit. I had to make my own personal and educated decisions after numerous treatment failures. More patients should be afforded the opportunity to explore and pursue alternative treatment options. In my particular case,

I encountered little support in my choices not to pursue traditional narcotic and poly-pharmaceutical management; yet for me, this was the best choice. It has been my experience as a patient and a practitioner that pain as a disease makes us all uncomfortable. The more we try to avoid the issue, the larger it becomes. If we can leap the hurdle of guilt associated with not having the ability to cure pain, then we become able to help our patients cope. To shift the focus from “treating” to supporting would afford an opportunity for chronic pain sufferers to be OK with things not being OK. —Joy Whipple, MD Dr. Whipple is an anesthesiologist in Rapid City, S.D.

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C OMM E NT A R Y

Suite Strife: Offing Older Anesthesiologists

ntergenerational conflict is disrupting some surgical suites as anesthesia groups and hospitals begin testing their senior physicians— and eliminating those who fail. Others are considering cognitive and physical tests for their senior members. Young physicians extol this trend as a way to “weed out those who should no longer be practicing.” A young Johns Hopkins

surgeon told the Washington Post, in December, that testing and weeding gives “those who are fully functional the freedom to practice without the stigma of ageism.” Seniors see agebased testing as ill designed, wrongly aimed and the epitome of ageism. Ageism is, of course, the age discrimination that permeates our pop culture, which glorifies youth, sexual potency

and athleticism. Pete Townsend, of the British rock group The Who, famously sang, “I hope I die before I get old,” while country music star Toby Keith twanged, “I ain’t as good as I once was/ I’ve got a few years on me now.” The trouble with extending ageist thinking to surgical suites is that youth, sexual potency and athleticism don’t get anesthetics done, at least not well.

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Experience, wisdom and focus, all common traits of seniors, work better. Marty Makary, MD, the Hopkins surgeon and weeder wiz, related in an essay in the Wall Street Journall how students and residents once labeled a senior surgeon, “Dr. Hodad”—an acronym for “Hands of Death and Destruction”—to get rid of him. It is easier to weed out people if you first demonize them. Running Out of Gas … or Just Pacing Themselves? Hodad vignettes, senior sophistries and weeding advice are easy to find now. The first talk at the American Society of Anesthesiologists Practice Management Conference this year was “Turning off the gas: The aging anesthesiologist.” The syllabus advised: “Aging … is characterized by degenerative changes in the structure and functional reserve of cells and tissues …. Many of these changes can adversely impact an anesthesiologist’s ability to practice safely.” It further cautioned that “learning becomes slower and requires more effort; short-term memory is impaired; creative thinking and problem-solvingg abilities decline; and intellectual quickness, on the spot reasoning and reaction time slows.” Providing a bit of gravitas to that cant, a recent editorial in Anesthesiology, titled “More than just taking the keys away,” warned ominously that “there are many studies that show associations between physician underperformance and increasing years” (2012;116:501-503). It is, of course, easier to jjustifyy selective testing and weeding w if it is based on physical attribuutes, not intergenerational biases. After reading th hese senior denigrations, some anessthesiologists might prefer being run over by a manure wagon than sufffering the humiliation and disgraace of aging. But that is already happening. Extrapolating individual examples of demented or o dysfunctional seniiors to disparage alll of them is fodder foor the wagon. Many stuudies show young doctors make m more mistakes in practice and in life than t is no shortolder ones. And there age of young ignorramuses to mock, even if derision is not the style of seniors, perhaps too their detriment.

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COMME N TA R Y One can only imagine tests designed by the currently young for weeding old physicians: Robert E. Born This Way Johnstone, MD by L. Gaga is a textbook of obstetrics? MTV stands for Medical TeleVision? YOLO (“you only live once”) is appropriate medical advice? Answer “true” to any of these and get offed.

Or maybe no written tests once in practice—just peer reviews and clinical outcomes. Standards are universal, age diversity desirable, sponsored knackery repugnant. Anesthesia practices can benefit especially from experienced clinicians in this era of drug shortages. During a recent neostigmine shortage, seniors became the go-to experts on edrophonium, a classic and restocked reversal agent. Seniors can answer simple questions, such as why there are little hooks

on the top of face masks, as well as significant ones like what to do if supraglottic airways are missing. Most senior anesthesiologists have more experience with face-mask anesthesia than their recently trained counterparts. Clinician competence is certainly necessary for safe anesthesia and good patient outcomes. As competency tests are developed and authenticated, let’s hope they are universally applied. Singling out one generation to test, at the exclusion of others, is a sure way to

miss incompetents. And if we get into intergenerational warfare YIPers might lose, as competitive and goal-oriented baby boomers defend themselves and the “Greatest Generation” teaches everyone how they earned their name. —Robert E. Johnstone, MD Dr. Johnstone is an aging, but still highly competent, professor of anesthesiology at West Virginia University in Morgantown, and a frequent contributor to Anesthesiology News.

Enter the YIPer One could lampoon young anesthesiologists preoccupied more with Facebook than patients, tweets than theories, social fluff than science fare. The youngest ones seem most likely to call in sick, to have styles characterized more by motion than progress. Could these young and inefficient practitioners (YIPers) be jealous of experienced and productive seniors, trying to achieve through selective tests what they cannot through work accomplishments? Studies show workers from 18 to 47 years old are more stressed and angry than those 48 and older. Perhaps their current stress is due to childhoods of trophies for just showing up, and to schools with no-faill marking systems. Maybe YIPers should have to pass special tests designed by seniors: If the Internet goes out, how can you get home? How did the ether screen get its name? Who is buried in Grant’s Tomb? I hope the day of dueling tests does not come to pass, but I’m not opposed to a single test for everyone that measures what is needed to practice competently, to achieve good patient outcomes, for the privileges requested.

THE STRENGTH TO HEAL

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AD LIB BREATHING

CONTINUED FROM PAGE 1

such events, who became pleasantly drunk by inhaling the vapor. Crawford Long, a Georgia physician attending a frolic, noticed that a person injured under ether’s influence didn’t feel pain. Long had a brilliant idea. Wondering if ether might relieve the ordeal of surgery, he saturated a towel with it and had a patient breathe the fumes. Long then painlessly removed two small tumors from the patient’s neck. After much thought, he set his fee for the case at $2.00. Long performed his miracle in 1842, four years before Morton’s demonstration. An isolated country doctor with a small practice, he didn’t publish his findings. Nobody heard about it. But surgical anesthesia was in the air, so to speak. Morton, an ambitious dentist with no university degree, had heard about ether from the physician and chemist Charles T. Jackson and began using it in his dental practice. The “new and valuable discovery” was reported in a Boston paper and Morton got himself invited to make a public demonstration. The patient, a twenty-year-old man named Edward Abbott, had a vascular lesion on the side of his neck needing removal. Morton arrived late to the Ether Dome the day of his appointment with history—the instrument maker had only just finished the glass inhaler Morton had designed. The eminent surgeon, Dr. John Warren, irritated by Morton’s delay, was about to start the procedure without him. “Sir, your patient is ready!” scolded Warren. Morton apologized and set to work, and Abbott was soon asleep. “Sir, your patient is ready,” said Morton, echoing Warren. Warren took ten minutes to remove the lesion. When he was done he turned to the audience and famously pronounced, “Gentlemen, this is no humbug.” A year previously, Morton’s partner, Horace Wells, had conducted a similar demonstration at Massachusetts General using laughing gas (nitrous oxide), an anesthetic less potent than ether. Wells’s display had ended in failure and ridicule when the patient complained of pain. A month after Morton’s successful presentation, Dr. Oliver Wendell Holmes wrote to him proposing the term anesthesia (Greek for “without pain”) for the magic that had been worked. A raft of new words followed. Anesthetistt came to mean anyone who gave an anesthetic. A physician anesthetist such as myself, whose medical specialty is called anesthesiology, is known as an anesthesiologist. Morton tried to disguise the nature of his anesthetic, giving it the name Letheon, but soon got into a bitter public struggle with Long, Jackson, and Wells to claim credit for the breakthrough. Morton tried unsuccessfully to patent ether. He died a pauper in 1868 and is buried in that loveliest of cemeteries, Mount Auburn, in Cambridge. The inscription on his headstone reads: By whom, pain in surgery was averted and annulled Before whom, in all time, Surgery was Agony Since whom, science has control over pain Rest in peace.

Replica of Morton Inhaler Image courtesy of the Wood Library-Museum of Anesthesiology, Park Ridge, Illinois. Image not found in book.

Recently, the venerable New England Journal of Medicine marked its 200th anniversary by naming the most important article in its history. The article chosen was H. J. Bigelow’s 1846 report on the discovery of ether anesthesia. Bigelow was a professor of surgery Early prototypes of the Laryngeal Mask Airway. at Harvard. It had been he who Image courtesy of Archie Brain, MD. arranged Morton’s public demonstration in the Ether Dome. were syringed, and ammonia presented to the nosBigelow’s review gave an account of Morton’s trils and administered internally. For fifteen minmethod: “A small two-necked glass globe con- utes the symptoms remained stationary, when it tains the prepared vapor, together with sponges was proposed to use active exercise, as in a case of to enlarge the evaporating surface. One aperture narcotism from opium. Being lifted to his feet, the admits the air to the interior of the globe, whence, patient soon made an effort to move his limbs, and charged with vapor, it is drawn through the second the pulse became more full, but again decreased in into the lungs. The inspired air thus passes through the sitting posture, and it was only after being comthe bottle, but the expiration is diverted [out of the pelled to walk during half an hour that the patient inhaler] by a valve in the mouth piece….” was able to lift his head. Morton’s inhaler was a vaporizer, anesthesia Let’s review the tools Bigelow had in his arsenal machine, and gas delivery system all rolled into one. to treat an anesthetic overdose: In his article, Bigelow enumerated the many failed Withdrawal of the anesthetic gas Cold compresses to the head anesthetic attempts prior to Morton and documented his own anesthesia experiments. His descripA squirt gun aimed at the ears tions made two things clear. First, a revolution was Ammonia brewing. Second, everyone was winging it, in over Exercise their heads, making things up as they went along. The good news was that this left a lot of room for Here is Bigelow on one of his own ether attempts improvement. f limiting, making it a fortugone awry: Ether’s effects are selfI found the pulse suddenly diminishing in force, nate choice for the first anesthetic agent. Initially it so much so, that I suggested the propriety of desist- stimulates both respiration and blood flow. In deeper ing. . . .The respiration was very slow, the hands stages of ether anesthesia, ether depresses both the cold, and the patient insensible. Attention was now heart and breathing. But it depresses breathing more. of course directed to the return of respiration and This means that a patient will stop inhaling ether circulation. Cold allusions, as directed for poison- before a heart-killingg dose can be administered— ing with alcohol, were applied to the head, the ears exactly what was happening to Bigelow’s patient.

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A D L IB “Anyone can push a plunger,” my attending physicians would say to me. Meaning, what’s the plan after the Pentothal goes in and the body forgets to breathe? I often felt, pushing that plunger then, the presence of something vast, terrifying, and doubtful nearby. I imagined being the pilot of a small boat going over the edge of a very high waterfall, a waterfall at the end of the world. The drop was one long, sickening, slow-motion glissando down to the rocks and spray below, and there was no stopping once it began. I felt that nauseating drop all through the first year of residency as I slowly gained confidence around an airway. Then in the second year, when I was left alone to do unsupervised inductions, I felt it all over again. I felt it once more when I started in private practice many years ago. I still feel it occasionally—much more than I’d like—now.

It wasn’t Bigelow’s armory Thouugh it wasn’t known at the time of of techniques that saved the Hannaah Greener’s death, chloroform has a toxicc effect on the heart. Every so often, moment. It was the ether itself. As excitement about aneslong bbefore it slows breathing, chloroform provokes a cardiac arrest. Ultimately, thesia spread, new agents, some this leth hal side effect caused it to be abanmore dangerous than ether, doned as an anesthetic. were tried. And thus it wasn’t It’s apparent from Dr. Meggison’s teslong after the discovery of timoony he had no idea what had gone modern anesthesia that people began to die of it. wrong with his patient. On January 28, 1848, Hannah Greener, a healthy fifteenyear-old girl from a town Modern anesthetic gases are near Newcastle, Great Britain, Chloroform Tin derived from ether. It’s still corunderwent the removal of an Image courtesy of the Wood rect to say that we etherize Library-Museum Museum of Anesthesiology Anesthesiology, patients, although an anesthetic ingrown toenail, for which she Library Park Ridge, Illinois. Image not found in book. begins differently now. was given the new anesthetic, chloroform. The anesthetist, In the 1930s intravenous Dr. Meggison, gave this account: agents that produced an immediate state of unconI seated her in a chair, and put a teaspoon of chlo- sciousness were synthesized. The new drugs, ultraroform into a tablecloth, and held it to her nose. I short-actingg hypnotics such as Sodium Pentothal, told her to draw her breath naturally, which she traveled quickly through the bloodstream to the did…. When the incision was made, she gave a strug- brain. Before then, patients had to breathe anesthesia gas gle or jerk, which I thought was from the chloroform not having taken sufficient effect. Her eyes were to get to sleep, which could be scary and sometimes closed, and I opened them, and they remained open. provoked coughing fits. Intravenous induction soon Her mouth was open, and her lips and face blanched. replaced direct inhalation of vapor as the method of When I opened her eyes, they were congested. I choice for starting an anesthetic. called for water when I saw her face blanched, and I Pentothal was still the standard when I was a resdashed some of it in her face. It had no effect. I then ident (propofol hadn’t been invented yet) and for gave her some brandy, a little of which she swal- my first year in the operating room an attending lowed with difficulty. I then laid her on the floor and physician always stood by when I gave it. The danattempted to bleed her in the arm and jugular vein. ger is that as soon as it interrupts consciousness, She was dead…. The time would not have been more Pentothal (as does propofol) also causes spontanethan three min from her first inhaling the chloro- ous respiration to stop. It does this by inhibiting form till her death. the brain’s respiratory center. During normal sleep, For the record, Dr. Meggison’s arsenal included: the respiratory center reminds the muscles of respiForcing the eyes open ration to keep working, which is a very good thing. Water in the face But under the influence of the induction agents, the Brandy respiratory center temporarily “forgets” to do this— Bleeding Ondine’s curse.

A Hole In The Neck Three years after my encounter with Otto, I met another patient who increased my store of humility, only this time I was in private practice without a teacher to bail me out. The patient was a forty-four-year-old woman—let’s call her Rose—who needed surgery on her bladder. The procedure was more complicated than Otto’s. The urologist said he might need me to control Rose’s respirations intermittently during the case, that is, to breathe for her. This can be done by squeezing the anesthesia reservoir bag, which blows air into the lungs. While it’s possible to do this with an anesthesia mask strapped on the patient’s face, it’s easier and safer with a breathing tube in the trachea. My plan was to put a breathing tube in Rose. After giving Pentothal, I put a mask on Rose and squeezed the anesthesia bag. Her chest rose and fell, confirming air was passing in and out of her lungs. Then I gave Rose a paralytic agent to relax the muscles around her airway. Anesthesiologists commonly use paralytic agents (also called muscle relaxants) during intubation to make it easier to visualize the vocal cords. When all goes well, once the cords are visible, a breathing tube can be passed between them into the trachea. I inserted a laryngoscope into Rose’s mouth and looked for her vocal cords. No go. She had a short neck and her trachea was positioned very far forward. It was too great an angle to see around with my laryngoscope blade. I tried another blade with a different shape. I still couldn’t see Rose’s vocal cords. I went back to ventilating her by mask. Soon, the muscle relaxant (which had also paralyzed Rose’s diaphragm) wore off, and Rose was breathing for herself again. I had not done what I’d set out to do. But I had a stable, anesthetized patient who was breathing on her own. “It’s all right,” the surgeon told me. “You can do the case with a mask. I won’t be long.” Hadn’t I heard that before? Surgeons are notoriously bad at estimating their time. And what do they know about the difficulties of masking a patient? Nada. I should have remembered Otto. I should have thought more about the two intubation attempts I see breathing page 12

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had just made and the possibility that Rose now had blood in her airway. I should have woken her then and there and cancelled the case. Knowing we were facing a difficult airway, we could have come back another day with a better, safer strategy. One such plan would have been an awake nasal intubation—passing a small endotracheal tube through the nose and into the trachea of a conscious, spontaneously breathing patient. Sedation and local anesthesia make the technique tolerable for the owner of the nose. Unfortunately, I didn’t consider any of that.

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Instead, I agreed, accepting the surgeon’s glib judgment that a mask would do, and that he would be quick. I took off into the fog. Rose wasn’t as heavy as Otto, or was her neck as thick, but she became partially obstructed anyway about a half hour into the case. It’s possible that her throat had become swollen from my two intubation attempts. Or perhaps I had caused some bleeding that was now irritating her vocal cords, which were partially closing in response. In any case, none of my tricks to keep the airway clear were working. No extra pair of hands materialized to help. This time I knew I couldn’t get a breathing tube in, because I had already tried to and failed. The urologist was only halfway through his procedure, and he wasn’t having an easy time of it either. “How’s it going up there,” he said. “She’s hard to ventilate.” “I need you to paralyze her and control her respirations,” he said. “I thought you told me you weren’t going to need that,” I said. “Five minutes. That’s all I need.” Paralyzing her again now, however, was out of the question. The one thing I had going in my favor was that Rose was still breathing for herself. At this point I didn’t want to interfere with that. I remembered Otto, and a panicky feeling began building. If I lost the airway I would lose Rose, and I might lose the airway at any time. I sent a message to the front desk asking for backup. No other anesthesiologist was available. The urologist, intent on his procedure, was of no help. My mind began to wander. Oh, to be a resident again, when plenty of help was always around. Why were airways so troublesome? So complicated? Why not easy and simple? Why couldn’t every patient just be born with a hole in the neck leading straight to the trachea? Deep in my brain, something clicked. “She needs a tracheotomy,” I said. “Whatever you think,” said the surgeon. “I just need you to paralyze her.” A tracheotomy involves making an incision in the front of the neck and creating a direct opening into the trachea, through which a short breathing tube is passed. Was it overkill? Perhaps. But overkill was better than kill. A head and neck surgeon, Dr. Anthony, y had just finished a case and was still in the hospital. We summoned him to the room.

Anthony and I worked well together. I’d learned by then to stay on good terms with all head and neck surgeons. They have an intimate knowledge of airway anatomy and understand better than any other surgical specialists the difficulties anesthesiologists face. By now Rose had respiratory stridor, a croupy sound caused by air turbulence, and a signal to everyone in the room that all wasn’t well at the head of the table. The pulse oximeter read 92 percent. The number meant that Rose was still getting enough oxygen, but it was barely reassuring. Five minutes before, the number had been 94 percent. As with Otto, I might have muddled through to the end of the case, but I was done with muddling. The surgeon still needed muscle relaxation, and it wasn’t safe to provide that relaxation until Rose’s airway was secure. Dr. Anthonyy agreed. The circulating nurse hastily prepped Rose’s neck and got an emergency tracheotomy tray. The urologist abandoned his procedure for the moment to assist Anthony. The two men worked in close quarters for ten minutes while I struggled to keep the airway open. Emergency is not a word you like to see paired with tracheotomy. The neck brims with a profuse tangle of blood vessels lying in ambush for the unwary surgeon. If you lose control of the operative field during a tracheotomy—meaning if the bleeding becomes uncontrollable—you’ve just run out of options. After an eternity Anthony called out, “Trach tube!” The scrub nurse passed the tube to Anthony, who slid it into the trachea. The ordeal was over. I connected my breathing circuit to that blessed tube, a direct path to Rose’s lungs. It was safe to paralyze Rose now with a muscle relaxant, which the urologist required to finish his case. Rose ended up with a neck scar she hadn’t bargained for, but she’d live to tell her grandchildren about it. I had egg on my face and some explaining to do, but it beat the alternative. A week later I sat with Rose and we talked. She was philosophical, which was more than I felt I deserved. “I made an error in judgment. I should have cancelled the case when I couldn’t intubate you,” I said to her. “You kept me alive,” she said. “You were wonderful.” I hadn’t been wonderful. What I had been was lucky that the right man was around when we needed him.

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Telomere Length Linked to Fibromyalgia Pain Washington—Considered a marker for biological aging linked to increased risk for morbidity and mortality, shortened leukocyte telomere length now has been associated with pain in fibromyalgia, researchers at the University of Michigan have found. The investigators also found that shortened telomere length was directly related to evoked pain sensitivity and altered

brain structure, suggesting that pain may accelerate cellular aging. “Telomeres are protein complexes that cap and protect the ends of chromosomes,” said Afton L. Hassett, PsyD, associate research scientist in the Chronic Pain & Fatigue Research Center at the Ann Arbor institution. “Critically short telomeres put cells at risk for apoptosis and death.

“This is the first study to show that telomere length is associated with clinical pain alone, as well as experimental pain. I will also caution, however, that this was a highly exploratory study.”

osteoarthritis, osteoporosis and several forms of cancer. Sex, race, socioeconomic status and even level of education appear to affect the length of a person’s telomeres, as do behaviors and physical characteristics such as Feeling One’s Biological Age smoking, body mass index, stress and Telomere length has been associ- depression. ated with a variety of age-related illThat suggests telomere length is a nesses, including cardiovascular disease, measure of biological as opposed to chronological age, Dr. Hassett said. To determine the relationship, if any, between telomere length and pain, the researchers evaluated leukocyte telomere length in 66 women with fibromyalgia and 22 healthy female controls. All volunteers completed questionnaires including the Brief Pain Inventory (BPI; 0-10 scale) and the Center for Epidemiologic Studies Depression Scale (CESD). Twelve of the women with fibromyalgia underwent quantitative sensory testing and neuroimaging. After controlling for age, pain was found to be associated with shorter telomere length (rrpartial = –0.267; P=0.039), according to Dr. Hassett, who reported the findings at the 2012 annual meeting ng of the American Society of AnestheA siologists (abstract 012). Patients were cateegorized as experiencing high levels l of pain (BPI ≥5; n=30) or lower levels of pain (BPI<55; n=31). Women who scored at least he cutoff a 5 on the BPI—th for “high” levels of paain—were more likely to have sh horter telomeres regardless of th heir chronological age (F=5.39; F P=0.024). “This difference,” Dr. D Hassett said, “represents appproximately five years of aging.” T That estimate is based on a previouus study that linked the deteriorattion of telomeres to time (Proc Natl Acad Sci USA A 1998;95:56077-5610). The researchers fouund no association between sscores on the CESD and ttelomere length. “We also wonderedd whether combining age and depression might have an additive effect,” Dr. Hassett continued. After adjustting for age, patients categorized ategorized as high pain/high depression had telomeres that were 265 base pairs shorter, on average, than those with low pain/low depression (P=0.043), a difference consistent

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with approximately six years of chronological aging. In quantitative sensory testing, the researchers found a “very high correlation” between telomere length and sensitivity to pain that was statistically significant. “People with the shortest telomere lengths were by far the most sensitive to pain,” Dr. Hassett said. Neuroimaging in a subset of 12 patients found that telomere length also was related to a person’s volume of gray matter. “We found that the fibromyalgia patients with shorter telomeres showed less brain matter volume in pain processing areas of the brain,” Dr. Hassett said. Background Inflammation A Possible Explanation Exactly why telomere length has such a significant association with these variables is open to interpretation, although Dr. Hassett offered a possible explanation. “The predominant theory is that decreases in cortisol levels may create an environment where there’s greater lowlevel inflammatory activity,” she said. “Ultimately, Ultimately, we w would really like to verify these results in a larger study and even consider chronic pain patients with other diagnoses.” W. Michael Hooten, MD, associate prrofessor of anesthesioology at Mayo Clinic in Rochester, Minn., calledd the study fascinating. “T This is a unique avenue off investigation that could brooaden the understanding of the m molecular mechanisms of chronic ppain,” Dr. Hooten said. “It’s a relativelyy small sample, and it’ll be interesting to see how this plays out in a larger group of patients, to see if the findings can be replicated. “It would aalso be interesting to determine iif treatment of the underlying pain condition can halt or reetard telomere shortening,” Drr. Hooten continued. “This coulld have important clinical impliications. For example, if an assoociation exists between treatment response and telomere len ngth, this could help identify and a measure the effectiveness of various interventions for fibromyalgia.” —Michael Vlessides

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After Three Years, DEA Investigation of Pain Doctor Lacks Conclusions

he recent revelation that Lynn Webster, MD, president of the American Academy of Pain Medicine (AAPM), is under investigation by the U.S. Drug Enforcement Administration (DEA) likely caught most of the pain medicine community by surprise. The DEA searched Dr. Webster’s Lifetree Pain Clinic in Salt Lake City three years ago, following numerous reports of patient deaths resulting from opioid overdoses. Dr. Webster, a prominent expert in the use of analgesic drugs, acknowledged that as many as 20 former patients of his clinic have died of narcotic overdoses, according to a recent article in the Milwaukee Journal Sentinel. However, Dr. Webster raised the possibility that a nurse practitioner or a physician assistant may have handled the prescriptions in the cases where deaths occurred. The Sentinell reports Dr. Webster as saying, “I don’t think any of the deaths were for scripts I wrote. They were from staff.” Representatives from the U.S. Attorney’s Office in Salt Lake City declined to comment on the investigation. Sue Thomas, the DEA’s supervisory special agent in Salt Lake City, said no determination had yet been made in the case. “No findings have been made one way or the other,” Ms. Thomas said. “You take as much time as it takes. You are talking about a person’s livelihood.” The DEA investigation is occurring at the same time as a decade-longg rise in the number of overdose deaths in the United States involving opioid painkillers. According to recent findings by the Centers for Disease Control and Prevention, the number of such deaths increased fourfold in 11 years, from 4,030 in 1999 to 16,651 in 2010.

‘I’ve known Lynn a long time. He’s an exemplary provider. He cares about his patients and knows as much as anyone about treating patients with opioids.’ —Gilbert J. Fanciullo, MD

“I’ve known Lynn a long time,” said Gilbert J. Fanciullo, MD, director of pain management at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. “He’s an exemplary provider. He cares about his patients and knows as much as anyone about treating patients with opioids.” Dr. Fanciullo stressed that physicians at acaA Show of Support demic centers, like Dr. Webster and himself, see Many of Dr. Webster’s colleagues reacted to the the highest-risk patients. This group includes pain news with surprise and words of support for the patients with a history of substance abuse and menleading pain specialist, who regularly lectures on tal health disorders who are at the greatest risk for preventing opioid abuse, and whose Opioid Risk overdose and suicide. “We do our best to identify patients with other Tool to identify patients most likely to abuse opiproblems who shouldn’t be treated with opioids, oids is used by legions of doctors.

Comment From Dr. Lynn Webster

“T

he goal is safe prescribing, but that doesn’t happen in a vacuum. Health care involves a complex set of relationships, and the use of controlled medications to treat pain touches on many of them: the patient’s responsibility, the health care plan (assuming there is one), community resources, the physician’s level of experience, etc. Physicians make choices about prescribing controlled medication in the moment, based on numerous factors, including the patient’s individual medical history. “So when we are talking about ‘safer’ prescribing, we are really talking about addressing all of these things and not just the drug selected or the amount prescribed. The pain medicine community must focus on minimizing risk while still meeting the needs of patients; this is what I have and will continue to push for as a researcher and educator in this field.”

but we all recognize the best systems are imperfect,” said Dr. Fanciullo. “It’s still possible for people to slip through the cracks.” Phil Saigh, spokesman for the AAPM, responded to the investigation by releasing an official statement that echoed Dr. Fanciullo’s comments: “Physicians in the AAPM treat patients who have suffered horrific injuries or are terminally ill and in great pain. A small percentage of those terribly suffering patients die—not as a result of appropriate medical treatment, but in spite of it.” The AAPM’s statement continues: “As a society, we must care for the millions of people who suffer from pain, while preventing those same patients from ending their lives by overusing their medications. Dr. Webster is one of the most highly respected physicians in the field and has worked tirelessly to prevent the overprescribing and misuse of opioids as part of a pain treatment regimen.” Dr. Webster recently wrote an opinion piece for the Milwaukee Journal Sentinell in which he expressed concern about the possibility of a chilling effect that the investigation could have on the amount of opioids legitimately prescribed by physicians for patients in chronic pain. (Dr. Webster declined to answer a list of emailed questions but directed the publication to the Sentinel letter; he also offered the comment in the box below.) “As tragic as this is for families of a lost one, it would be a cruel consequence if an overreaction to these legitimate concerns makes it more difficult for blameless patients to obtain relief from excruciating pain—or stymies efforts to develop more comprehensive treatments for pain,” Dr. Webster wrote in the opinion piece. “The anti-opioid climate already has resulted in the denial of medication to suffering patients. In many cases, doctors acknowledge a reluctance to prescribe opioids, even when they know a patient is in intense pain, simply because they do not want to be perceived as irresponsible or risk sanctions.” Pain specialists like Dr. Fanciullo are concerned about their well-respected colleague, but also understand the need for an investigation. “Twenty is an awful lot of deaths,” said Dr. Fanciullo, who added he doesn’t know of any patient deaths related to opioids he himself has prescribed. “So, if the DEA investigates a single provider who has that many patient deaths related to the opioids he prescribes, the DEA is performing its job.” In the meantime, Dr. Fanciullo, along with a large swath of the pain medicine community, wants to see the situation resolved soon, with as little damage as possible to Dr. Webster’s reputation. “I’m just worried about Lynn. I hope he’s OK. He’s a wonderful guy and a wonderful colleague,” Dr. Fanciullo said. “I model myself after Lynn, as a lot of us do. I hope this whole thing doesn’t hurt him too much.” —Dana Hawkins-Simons

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OIG Sees REMS Program Falling Short of Goals

fter four years, the effectiveness of the FDA’s mandatory Risk Evaluation and Mitigation Strategies (REMS) program remains open to question because drug companies have failed to comply with key reporting requirements and the agency lacks adequate enforcement authority to take action against them, according to a report by the Office of Inspector General (OIG) at the Department of Health and Human Services. Nearly one-fourth of the drug companies with medications in the REMS program were found to be in violation of legislatively approved timetables for data reporting, according to the OIG report. Furthermore, fewer than 15% of the companies had met all of the safety goals stipulated in their products’ REMS.

additional medication guides, patient package inserts, communications plans for health care providers and one or more ETASUs, such as patient and prescriber registries, specific training for prescribers and practitioners, or certifications in health care settings. Some REMS programs have become controversial among practitioners, such

as those involving erythropoietinstimulatingg agents and long-lasting, extended-release opioids. The main objections to those REMS often revolve around delays in access to medications that can result when implementing complicated REMS requirements. Drug manufacturers, which are responsible for REMS, have noted that they can only advise but not control

physician and patient behavior when it comes to prescribing practices and medication adherence. Lacking Information The OIG reviewed 199 REMS approved by the FDA between March 25, 2008, when the program officially began, and Dec. 31, 2011. To perform see REMS page 18

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As for the FDA, the agency has reviewed only one of 32 drugs whose REMS contain “elements to assure safe use” (ETASU), which usually are reserved for medications on the higher end of the risk spectrum—a gap that has undermined any assessment of the merits of that component of the REMS program. These findings “raise concerns about the overall effectiveness of the REMS program,” the OIG concluded in its Feb. 13, 2013, report. Under the Food and Drug Administration Amendments Act of 2007 and subsequent legislation, the FDA has been granted legal authority to require drug and biological product manufacturers or sponsors to establish a REMS program whenever the agency determines that one is necessary to ensure that a product’s therapeutic benefits outweigh its risks. REMS programs typically include

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the study, the OIG selected 49 sponsor assessments and interviewed FDA officials about them. OIG determined that nearly half of the assessments (23 of 49) were missing information that the FDA had requested. For example, one drug sponsor did not report the number of pharmacies that had been “deauthorized” to dispense its drug because of noncompliance with the REMS. The same sponsor also did not report the amount of the drug shipped to health care providers compared with actual patient orders. (The company was not identified in the report.) The problem, the OIG noted, is that the FDA lacks authority to take enforcement action against sponsors that fail to provide requested information, both in quantity and quality. The OIG recommended that FDA should seek this authority from Congress. The FDA “did not explicitly concur,” the OIG report noted, “but agreed that it should be considered if another opportunity arises” to make legislative changes to the REMS program.

The report also noted that more than 20% of the completed REMS assessments (10 of 49) had been submitted by sponsors after the dates specified in legislatively approved timetables (three to 70 days late, with a median of 17 days). Although the FDA has the authority to take action against a sponsor when a statutory requirement is violated, it never has done so. (Penalties for failing to comply with a statutory REMS requirement include barring the drug from interstate commerce and imposing civil fines of up to $250,000 per violation, and up to $10 million for continued violations.) The FDA determined that only seven of the 49 REMS had met all of their goals, whereas 21 had not. Of the remaining 21, the FDA could not determine whether 17 had met the goals, and had not assessed the other four. The FDA also needs to develop a plan to “identify, develop, validate, and assess the effectiveness of REMS.” And because the FDA had evaluated only one of 32 drugs having ETASUs, it “has limited data to demonstrate that the remaining REMS with ETASUs

effectively ensure safe use of drugs or meet statutory requirements to minimize burdens on patients and the health care system.” In its comments, the FDA replied it had spent much of the past three years developing and implementing the REMS program.

Among other recommendations, the OIG said the FDA should identify REMS that are not meeting their goals and work with sponsors to correct deficiencies; evaluate one ETASU per year as required by law; work with sponsors to obtain missing

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PA IN M E D ICIN E my knowledge, they have never been shown to improve patient safety or reduce harm,” said David S. Craig, PharmD, director of the pain and palliative care residency program at the H. Lee Moffitt Cancer Center and Research Institute, in Tampa, Fla. “The FDA is doing its best with the new authority given to them, but I think they also don’t really want to monitor and oversee both the implementation and impact all of these REMS programs. In addition, they

information; and complete its own reviews within 60 days. The FDA agreed with these recommendations. The nation’s branded drug industry association did not have much to say about the OIG’s findings. “We look forward to reviewing the report and continuing to work with FDA to help ensure that REMS effectively improve the safety of medicines while not unnecessarily burdening patients and health care professionals,” said Matthew Bennett, the senior vice president of Pharmaceutical Research and Manufacturers of America, when asked to comment. A Silver Lining? Not all of the OIG’s findings are negative, according to James M. Hoffman, PharmD, medication outcomes and safety officer at St. Jude Children’s Research Hospital, in Memphis, Tenn. Of the 199 REMS that had been created since the program’s inception in 2008, 99 were still in place in 2012. This reduction shows that the program is working and that it is helping to keep available important drugs that otherwise would have been withdrawn, Dr. Hoffman noted. “The decrease in the number of REMS is evidence of the FDA’s work to refine the program,” he said. “Keep in mind that some REMS (those with ETASUs) are designed to enable drugs to be on the market that would otherwise be withdrawn for safety risks. Thus, REMS continue to [help maintain] access to important therapies, which is a clear success for REMS.” Others disagreed. REMS programs “have no precedent, and even though they seem like ‘good ideas,’ to

have very [few] tools to evaluate the impact and outcome of any REMS and also likely lack the manpower to ensure that all drug manufacturers are complying with the requirements.” Bonnie Kirschenbaum, MS, FASHP, a health care consultant based in Breckenridge, Colo., said the concept of REMS “has merit.” After all, “one really can’t argue [against] educating prescribers, pharmacists and patients about using a drug in the most advantageous and

safest way possible.” Unfortunately, the REMS program has been weakened, Ms. Kirschenbaum said, by ongoing controversy over how to interpret the specific components of the program and the overcomplication of its implementation. “This has significantly diminished any possible returns we might have gotten from this initiative, however wellintentioned it may be.” —Ted Agres

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The Life and Times of a Rock ’n’ Roll Voice Surgeon Toronto—Rolling Stone magazine called him one of the “25 Best Things in Rock” last year. He trades 3 a.m. emails with pop diva Adele. He rubs elbows with the likes of Aerosmith frontman Steven Tyler and Julie Andrews, Mary Poppins herself. Ladies and gentlemen—Dr. Steven Zeitels. Celebrities heap high praise on Dr. Zeitels, the Eugene B. Casey Professor of Laryngeal Surgery at Harvard Medical School and director of the Center for Laryngeal Surgery and Voice Rehabilitation at Massachusetts General Hospital, both in Boston. “I’ve been in awe of his compassionate care, his amazing skills as a surgeon, his unbridled passion for creating new and effective ways to restore voices that have been lost or damaged by disease or trauma, not to mention his leadership in bringing together renowned scientists from varied disciplines to collaborate on solving human voice loss,” Ms. Andrews gushed at a recent Voice Health Institute fundraiser at the Beverly Hills Hotel, in Los Angeles. She and several others of Dr. Zeitels’ patients—including Lionel Richie, Christina Perri, broadcasters Joe Buck and Dick Vitale, and The Who’s Roger Daltrey— established the nonprofit organization to fund research into, and raise awareness about, voice restoration and breathing impairment treatments. Ms. Andrews first came in contact with Dr. Zeitels in 2000, after a botched procedure with another surgeon left her without the vibratory layer of her vocal cord phonatory mucosa. “It never needed to happen,” Dr. Zeitels told attendees of a distinguished lecture he delivered at the 2012 annual meeting of the Society for Airway Management (SAM). “It was tragic. It not only scared other doctors, it scared patients.” Although some of the damage to Ms. Andrews’ Advertisement

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voice was irreparable, Dr. Zeitels was able to restore her vocal cord elasticity partially with a surgical approach he pioneered. The procedure employs potassium titanyl phosphate (KTP), a laser in the green visible light spec-trum, which had been used primarily in uro-logic and dermatologicc surgery until 2006, when n Dr. Zeitels reported thee first case series of pulsedd KTP procedures in laryn ngeal surgery (Ann ( Otoll Rhinol Laryngoll 2006;115:679-685). Sour Note for Laryngeal Surgery Dr. Zeitels told SAM attendees that Ms. Andrews’ initial surgical mishap sullied the public image of laryngeal and voice restoration surgery, but, like the vocal cords he repairs, his more recent surgical success with Adele largely restored its image. “I received an email from Adele’s UK physician at three or four in the morning in November 2011, and subsequently [from] her voice teacher and management,” he recalled. The singer had recurrent bleeding from a benign polyp and cancelled several tour dates. Once the blood in her vocal cord resorbed, he used KTP to photocoagulate the abnormal vessel and microsurgically remove the polyp. Following three weeks of voice rest, the singer resumed touring. “What was advantageous about this case was that

it created great interesst in the general public abbout voice issues since it simulated a reality TV sh how,” Dr. Zeitels said. “B By blogging and tweetin ng about her experieence, Adele created new aattention for the field oof laryngeal surgery. I’m now seeing more and n more cancer patients m who say they were w encouraged after hearing about her surgery.” Dr. Zeitels most recently developed a ““vocall cordd bi biogel” l (PEG-30) with Robert Langer, ScD, professor of chemical engineering at Massachusetts Institute of Technology, in Cambridge. In a study of dogs, PEG-30 significantly restored vocal cord elasticity in animals with damaged phonatory mucosa (Ann ( Otol Rhinol Laryngol 2011;120:175-184). Dr. Zeitels said he expects similarly positive results in human trials of PEG-30 slated to begin later this year and that the product will revolutionize vocal surgery. “The future for restoring vocal cords damaged from pathologies, surgery or wear and tear will be to use this material, which assumes the same elasticity as phonatory mucosa,” he explained. “Ultimately, in the majority of voice restoration microsurgery procedures, it will be as important to inject this type of material into vocal cords as it is to take diseased tissue out.” —David Wild

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Medical Center in Lexington, who is one of many pharmacists concerned about KPC infection. Those concerns were compounded by a n Centers for Disease Control and Prevention (CDC) report on the rising prevalence oof carbapenem-resistant enterobacteriace aceeae (CRE). According to the report, in th he last decade, hospitals have seen a fourfolld increase in CRE, with most of the increase attributable to Klebsiella species ((MMWR 2013;62:1-6). The fact that these superbugs are making their presence most felt in hospi-tals is not surprising: In healthy patientss, KPC may colonize the intestines witthout causing disease, but in patients whoose immune system is impaired, it can turn deadly. KPC can spread through human-tohuman contact and has been found to live on equipment such as catheters. In the past, K. pneumoniae typically had been treated with cephalosporins or carbapenem antibiotics, but the bacteria are becoming increasingly resistant. Thus, drugs such as colistin, polymyxin B and tigecyline are not always effective alone, so they have to be combined. “But there’s no real, solid data on the drugs of choice,” Dr. Rapp noted, and medical staff “are just kind of flying by the seat of their pants.” With no new antibiotics in the pipeline, “we really have a problem,” he stressed. “If you come down with one of these [superbug infections], your chances of dying are high—probably 40% to 50%,” a figure echoed in the March CDC report. KPC is “definitely something that’s on our radar,” y PharmD, BCPS, an infecsaid Claudine El-Beyrouty, tious disease pharmacist at Thomas Jefferson University Hospital, in Philadelphia. KPC most often is found among critically ill patients hospitalized for extended stays or in patients who go in and out of the hospital frequently, she said. At this point, most hospitals in the Northeast region of the country have y At Jefencountered it, according to Dr. El-Beyrouty. ferson, several patients per quarter carry the organism or show signs of being infected, she noted. The hospital manages the infections through a multitiered approach, Dr. El-Beyroutyy said. Infection control personnel track cases; once the organism is detected in a patient, the person is isolated and the chart is flagged. If the patient is discharged and later returns, the flag is reactivated and the person is isolated again. Caregivers treating these patients wear gowns and gloves and employ handwashing techniques. Pharmacists participating in the hospital’s antibiotic stewardship program try to reserve agents like colistin, tigecycline and amikacin specifically for KPC patients.

from a New York hospital. Medical staff knew the patient was colonized with KPC, so they isolated her and wore gowns, gloves and masks while treating her. Three weeks after that patient left the hospital, a cancer patient who had no contact with the infected patient developed KPC infection. Ten days later, a patient with an immune disease also became infected. NIH epidemiologists and infection control specialists scrutinizing the problem found that the organism had been transmitted from the first patient despite the fact that the health care team followed all infection control protocols. They implemented additional procedures to prevent further transmission, including more invasive testing of ICU patients; using rectal swabs to check for KPC carriers; building a wall to create a specific unit to care for and isolate KPC patients; paying monitors to ensure everyone followed infection control procedures; and spraying hydrogen peroxide in rooms and on equipment. They reported their efforts in the journal Science Translational Medicine ((2012;4:148ra116). The last carrier was identified in December 2011, but patients still are swabbed to check for KPC when they arrive and before they leave the facility. The pharmacy faced several challenges during its KPC outbreak, according to Timothy Jancel, PharmD, a clinical pharmacy specialist in infectious diseases at the hospital. The isolation unit was created overnight, he said, so pharmacists had to quickly install a new drug-dispensingg unit and decide how emergency medicines would be delivered. They eduA Deadly Outbreak cated pharmacy staff on handwashing and isolation One of the most difficult Klebsiella outbreaks to protocols. Because some isolated patients took their control occurred in 2011, at the National Institutes own medicines, pillboxes leaving the unit had to be of Health (NIH) Clinical Center in Bethesda, Md., sterilized. where the organism infected 19 patients, seven of Pharmacists also worked with infectious diswhom died. That June, a 43-year-old woman with ease experts to come up with antibiotic regimens lung disease was transferred to the medical center to treat KPC as well as protocols to monitor those

treeatments, which involved educating a lot of peoplee, Dr. Jancel said. Medications like colistin have “beeen around for decades, but we never had to use it because we always had other options.” Devising acccurate dosing was challenging because labeling rrequirements were less stringent when colistin was aapproved, and the pharmacokinetics of the antibiotic still are not well understood, he added. They had to combine colistin with gentamicin and tigecycline for some patients, and then monitor th hem for side effects including renal toxicity, panh ccreatitis, nausea and vomiting. “We were using drug combinations typically not used on a daily basis.” The pharmacy also pursued investigational antibiiotics. One such agent was acquired and administered to a patient, but it was too late. Thee patient died a few days after starting theerapy. Dr. Jancel said he has helped thwart oother types of antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), but MRSA still had treatment options such as lin nezolid (Zyvox, Pfizer), trimethoprim/ sulfameth hoxazole and clindamycin. “With gramnegative g bacteria [like KPC], we’re getting to the bac point where we don’t have other options.” More From the CDC Report As daunting as Klebsiella is to eradicate in the nation’s hospitals, it isn’t the only superbug that poses a public health threat, the CDC report stressed; the authors also cited the emergence of resistant Enterobacterr and Escherichia species. By releasing these findings, the agency succeeded in getting a long-standing problem quite a bit of media attention. News articles in The Wall Street Journal,l The New York Times and television news outlets covered the report in seemingly alarmist terms. Most quoted one health official who termed these resistant organisms “nightmare bacteria,” and the CDC’s Arjun Srinivasan, MD, got a lot of coverage when he called these superbugs “a major threat emerging in our hospitals.” That statement is not surprising, given the 40% mortality associated with some of the superbug infections. Moreover, many of the bacteria have a kind of “panresistance” that renders them, in some cases, unresponsive to most available antimicrobials, which makes even combination treatments problematic, the CDC researchers reported. “Make no mistake, this is a public health crisis,” Dr. Rapp said. With the pipeline for new drugs looking dismal right now, “I don’t see much hope for a savior coming from Pharma.” Dr. Rapp thus urged hospitals to take the same types of proactive approaches detailed in the Science Translational Medicinee report. “We have several tools to prevent transmission and improve patient outcomes, including better infection control practices, strong antimicrobial stewardship programs and optimization of the pharmacokinetics/pharmacodynamics of our presently available agents to enhance the killing of these bacteria,” he said. “So we are certainly not powerless in this fight. But it’s going to be a long battle.” —Karen Blum

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ICU Checklist Avoids Unplanned Readmissions

hen used correctly, a checklist to guide the transfer of patients between the operating room and the ICU can help eliminate unplanned readmissions, Minnesota researchers have found. In a small quality improvement project, Nathan Smischney, MD, a Mayo Clinic Scholar in the Department of Anesthesiology at the Rochester institution, and colleagues set out to develop a tool to address the communication gap between the surgical ICU and the wards. They reviewed medical records from June to October 2011, identifying risk factors for ICU readmission and queried surgical teams in the ICU and receiving teams on the orthopedic, vascular and thoracic services about what they would like to know about incoming patients. The researchers developed a checklist and incorporated it into daily rounds. The checklist featured seven items addressing the clinical plans for pain, delirium, arrhythmias, respiratory support, antibiotics, diuretics, blood products, anticoagulation, antihypertensive management and any nursing concerns. The template was placed in charts accompanying patients to their new units. Dr. Smischney’s team then monitored use of the tool over a five-week period in 2012 and distributed surveys to the receiving hospital floor services to measure the quality of sign-out. The tool was used for 42 of the 141 dismissals during that period (a 30% compliance rate). The researchers identified 17 unplanned readmissions; in none of these cases did the team use the checklist. A preimplementation survey indicated a fairly high understanding of the care plan; a postimplementation survey demonstrated improved communication when the checklist was used. Dr. Smischneyy presented the findings at the 2013 annual congress of the Society of Critical Care Medicine (abstract 163). “It could be considered statistically significant and clinically important regarding a meaningful outcome benefit, however, a cause-and-effect relationship is hard to ascertain due to the small sample size and low compliance rate,” Dr. Smischneyy told Anesthesiology News. The low compliance resulted mainly because residents thought it was too long, he said. Still, “the surgical teams were very excited about it, as were we,” Dr. Smischneyy said. “It created a lot of enthusiasm in the ICU and in the

surgery department, and that’s the reason for continuing its use.” The checklist is being reformed by a group of fellows to shorten it to the most essential components for ICU staff and receiving surgical teams, he said. Eugenie Heitmiller, MD, associate professor of anesthesiology and pediatrics, and vice chair for clinical affairs at Johns Hopkins School of Medicine,

fully implement a checklist, the physicians and nurses who will use it most must embrace the document. It must be y easily available and widely in Baltimore, called the checklist a user-friendly, “helpful communication tool” despite disseminated. its inconsistent use. “If they study the “If someone sees this as not worthwhile, checklist on a larger scale with a larger they’re not going to use it,” she said. sample size, it may very well be shown “Checklists are good reminders,” Dr. Heitmiller added. “Even when you to be effective.” Dr. Heitmiller, r a panelist in a work- do same thing over and over, you can shop on implementing checklists at the forget something or get distracted. But Society for Pediatric Anesthesia’s annual you have to have it handy.” —Karen Blum meeting in October 2012, said that to

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Shifting the Main Focus of Acid Suppression to the Critically Ill Las Vegas—A San Antonio health care system markedly reduced unnecessary use of proton pump inhibitors (PPIs) for stress ulcer prophylaxis (SUP) in the ICU and ended up saving $80,000 annually. At a Bostonarea hospital, researchers determined that reducing inappropriate PPI use among general medicine patients could lead to yearly cost avoidance in the

neighborhood of $1 million. Both initiatives, presented at the December 2012 Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP), were undertaken to address persistent inappropriate use of PPIs, which has been linked to higher hospital costs and an increased risk for Clostridium difficilee infections.

“Many of our general medicine patients were on PPIs or H2-receptor agonists constantly, and no one was following the ASHP 1999 stress ulcer prophylaxis guidelines,” said Paige Cuellar, PharmD, a critical care specialist with the five-hospital Baptist Health System, in San Antonio. Because those patients often are not good candidates for SUP, Dr. Cuellar

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decided to shift use of SUP where it is needed most—in the ICU, where patients often are ventilated for more than 48 hours and thus face a heightened risk for gastrointestinal (GI) bleeding (poster 5-050). “Our goal was to reduce PPI overuse among patients who no longer needed mechanical ventilation and who had no other primary risk factors for GI bleeding,” she said. The ICU proved an ideal venue for tracking and changing PPI prescribing habits, because all 134 of the system’s adult ICU beds are monitored around the clock by a tele-ICU, which augments observation and care by the on-site staff. Critical care physicians and nurses at a remotely located tele-health facility continuously track real-time patient information, including lab values, medications and vital signs. The system, called the eICU LifeGuard initiative, is supported by Philips Healthcare’s IntelliSpace eCareManager platform. The remote staff, for example, alerts floor nurses to check daily if SUP is appropriate. “Without that electronic reminder, floor nurses could of course assess patients at the bedside every day,” Dr. Cuellar explained. “But with the tele-ICU assisting, our on-site nurses have become much more aware and involved with this aspect of care. They began approaching pharmacists and telling us when they thought SUP was no longer appropriate.” Every evening during a two-month verification phase, tele-ICU nurses assessed the risk for GI bleeding for each patient in the 38-bed ICU at one of the system’s hospitals. The threeweekk intervention phase that followed involved all adult ICU beds. On-site nurses and pharmacists recommended 102 conversions from IV to oral PPIs; 86 (84.3%) were accepted. Discontinuation of SUP was recommended 173 times; prescribers accepted 91 (52.6%) of the recommendations. The cost of SUP treatment decreased from $1.06 per adjusted patient-dayy to 77 cents and the projected annual cost savings from decreased SUP amounted to $78,052. “We were able to get nurses well educated about the appropriateness of SUP,” Dr. Cuellar said. “It was very

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PR N important to start weaning patients from PPIs when they were sent to the floors, because after that there aren’t enough clinical pharmacists to cover all patients and check for appropriate PPI use.” Monitoring PPI use in the ICU is now standard practice. “This study offers excellent findings and underscores the need to educate clinicians and patients that PPIs may be harmless in the short term, but that overuse can lead to unexpected problems,” said Chandra Sekar, RPh, PhD, associate professor of pharmaceutical science at the University of Findlay School of Pharmacy, in Findlay, Ohio. “Physicians and other providers need to follow current guidelines for stress ulcer prophylaxis in hospitalized patients and use PPIs only for patients who really need them—which is less than 10% of the population—and not to prevent a bleed that’s never going to occur.” When Is Use in Noncritical Patients OK? At Northeastern University’s Bouvé School of Health Sciences, in Boston, researchers analyzed the economic effects of misusing PPIs for SUP in the general patient population (poster 3-097). “Our institution might save more than $1 million annually if PPIs—specifically, pantoprazole—were [prescribed] more appropriately and if institutional guidelines regulated their use,” said lead author Chau Chu, a PharmD candidate. An examination of the literature revealed that inappropriate PPI use for SUP occurred in 58% to 92% of cases. By extrapolating those best- and worst-case scenarios to a local 191-bed teaching hospital, Ms. Chu and her colleagues projected savings that ranged from $338,397 to $2,844,477 annually. Their calculations accounted not just for drug costs, but also for treating patients with C. difficile and community-acquired pneumonia that may have resulted from PPI use. The researchers determined the incidence of PPI-induced illness from previous research and concluded that strict enforcement of ASHP guidelines for SUP simultaneously promotes optimal patient care and reduces costs.

In a third investigation, researchers found that 163 of 744 patients (21.9%) were taking PPIs when they were admitted to Swedish Covenant Hospital, a 313-bed teaching facility in Chicago (poster 3-101). Of those 163 patients, 37 (22.7%) were admitted with pneumonia and five (3.1%) were admitted with a fracture—rates comparable to those noted in other investigations of PPI risk, according to Zoon Park, PharmD, assistant director of pharmacy services at

Swedish Covenant. Documentation of any indication for PPI use was lacking in nearly half of the 163 patients using PPIs. “PPI use prior to admission definitely increased the risk of communityacquired pneumonia,” Dr. Park said. “Overall, the high rate of PPI use is concerning and may place patients at risk for complications.” These studies confirm previous findings about the overuse and risks associated with imprudent PPI use,

Dr. Sekar said. “Reducing inappropriate prescribing for inpatients must be done one hospital at a time,” he said. “The beauty here is that all hospitals want to save money, and this is a very simple way to improve the bottom line while at the same time getting better patient outcomes.” —Steve Frandzel Drs. Sekar, Cuellar and Park, and Ms. Chu reported no relevant financial conflicts of interest.

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Addiction Cited as Powerful Driver of Drug Diversion

iversion of controlled substances diversion is a major challenge for hospitals across the country. The problem is being fueled, in part, by the power of addiction: It is estimated that 10% to 15% of health professionals will develop serious substance abuse or addiction problems during their career (Crit Care Med 2007;35:S106-S116). Experts warned during a recent webinar that vigilance by all hospital staff— those in pharmacy, nursing, security, human resources and administration— is required to address this looming problem. Accrediting and regulating agencies have responded by requiring pharmacy departments to secure all controlled substances and identify the diversion of drugs in a timely manner. Advanced monitoring and dispensing systems, such as anesthesia dispensing carts, are helping hospitals better control their medication inventories, but diversion detection still remains a daunting task. Deborah Riffel, RN, MS, a senior clinical sales consultant for CareFusion’s Pyxis Technologies, in Kansas City, Miss., which hosted the webinar, recommended that hospitals take a systemized, multidimensional approach. “Hospitals must have explicit policies, detection methods, investigation processes and an organizational culture of readiness,” she said. “Without a systemized approach, hospitals are vulnerable to major drug diversion and subsequent public and legal repercussions. Pharmacy, nursing and anesthesia are the main players, but when developing policies and procedures we also recommend including human resources, security, risk management [and] administration—all of those people potentially can be involved.”

Technology Can Be a Potent Weapon … Technology upgrades are an important weapon in the fight against drug diversion, Ms. Riffel noted. She cited, as an example, moving from hospital narcotic storage boxes to automated controlled substance cabinets. One study showed a 321% increase in diversion detection rates after the installation of automated cabinets in the controlled substance vault in central pharmacy (0.36 diversions detected per 100 beds per year before installation vs. 1.12 diversions detected per 100 beds

per year after installation; Hosp Pharm 2005;40:977-983). The monitoring and reporting tools built into many technology systems also can be invaluable in fighting diversion. Such tools “[enable] us to look at behavior patterns,” Ms. Riffell said. One productive strategy is to closely examine data on two employees who always seem to waste drugs together or employees who

are canceling a lot of medication transactions, both of which can be mechanisms for drug diversion. “Having usable data is really the key to curbing diversion and allowing hospitals to have better means for detection,” she said. In addition to any reports generated from advanced monitoring technology, internal reporting to provide checks and balances also is needed, Ms. Riffell added.

Tricia Meyer, PharmD, associate vice president of pharmacy at Scott & White Memorial Hospital, and associate professor of anesthesiology in the Department of Anesthesiology at the Texas A&M University College of Medicine, in Temple, echoed Ms. Riffel’s sentiments of how timely reports generated by technological see addiction page 28

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advances result in improved detection rates. However, Dr. Meyer said that she strongly believes in implementing checks and balances as well. “The information in the reports needs to be confirmed or validated by manual chart auditing, and inconsistencies or irregularities ... found in the automated reports must be checked,” she said. Moreover, she said, a representative from the department with the team

member involved in the discrepancy should be involved in conducting the verifying audits along with a representative from pharmacy. Ms. Riffel also suggested having pharmacy participation in the nursing orientation and being very clear about expectations for controlled substance management. “One of the first steps pharmacy can take is to look at privileges and see who has access to the controlled substance vault and the automated dispensing cabinets on

each floor. Make sure employees have enough privileges to perform their job but not excess privileges to inappropriately access the system.” Ms. Riffel noted that because technology has moved into the operating room (OR) suite to specifically handle anesthesia medications, this may be a big change for anesthesia providers. “Nurses may be used to having this oversight but many anesthesiologists may not, and it is a change in their practice to get used to technology in

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each individual OR suite.” (For more practical strategies for reducing drug diversion, see Table 1.) … But It’s Not a Cure-All Even with the most advanced technology and monitoring systems in place, diverters who are familiar with a system still can find creative ways to obtain medication. Hospitals, therefore, should seek to incorporate a human component that may be absent from monitoring technology. “Nurse managers can be helpful in diversion prevention because they perform patient interviews asking about pain control,” Ms. Riffel said. “We discovered a case where a patient reported only receiving one pill, but it was documented that the nurse was removing

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PR N two pills from the dispensing machine.” Observing unusual employee behavior is another way hospitals can be vigilant for controlled substance abuse in the health care setting. Key behaviors to look for when trying to identify diverters include work absenteeism, excessive time spent near drug supply, confusion, memory loss, deterioration in personal appearance, personality change, denial and trying to deflect attention. For more information, visit the Drug Enforcement Administration’s Office of Diversion Control (http://www.dea diversion.usdoj.gov/pubs/brochures/ drug_hc.htm)). Dr. Meyer stressed the importance of educational programming for hospital employees so that they can recognize the signs and warnings of impaired colleagues (Table 2). “The substance abuser rarely reports his or her addiction, and coworkers are hesitant to become involved” or divulge their concerns, she said. “Staff must be informed that the consequences of not

reporting the individual in question can be significantly worse than reporting him or her. Addicted health care workers who are not discovered ... are in danger of hurting themselves, patients, the workplace and their profession,” Dr. Meyer cautioned. How can hospitals enforce controlled substance policies without making employees feel like they are constantly being watched by Big Brother? It can require walking a fine line. “Establish a culture of diversion

prevention and detection overall in the hospital and emphasize that it is every hospital employee’s responsibility,” Ms. Riffel said. “If employees know that there is a zero tolerance policy for medication diversion, they will be held accountable for their actions. For new employees, hospitals might emphasize controlled substance management and detection and the possibility of drug testing.”

@anesthesianews

—Megan Block

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

To learn more, visit www.thrombate.com

FELY PROCEED SA

Table 2. Signs and Symptoms of Substance Abuse in the Workplace Frequent absences from work without reasonable explanations Consistently late arrivals Missed appointments with patients Inaccessibility to patients and staff Inappropriate behavior with colleagues, staff and patients Conflicts with colleagues, staff and patients Avoidance of a supervisor or other colleagues Rounding on patients at odd hours Large quantities of drugs ordered Inappropriate orders and forgotten verbal orders

Thrombate III® (antithrombin III [human])—proven effective for patients with hereditary antithrombin (AT) deficiency during surgery, childbirth, and in the prevention and treatment of thromboembolism1 Thrombate III provides predictable amounts of AT to replace what is normally present in the body AT concentrate purified from human plasma and pasteurized to inactivate viruses, with no confirmed cases of virus transmission In clinical studies, no cases of thrombotic complications during surgical and obstetrical procedures were reported

Easy to administer1

Convenient to store and reconstitute1

One dosing formula Bolus intravenous infusion (not continuous infusion) Pregnancy category B

500 IU vials with sterile water for injection Filter and transfer needles provided Room temperature storage

A disorganized schedule and missed deadlines

Important Safety Information Thrombate III® (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deﬁciency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

Heavy drinking at hospital functions

In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia.

Vague letters of reference Multiple prescriptions for family members Long lunches or unnecessary breaks Decreased chart and work performance Source: Crit Care Med. 2007;35:S106-S116. 2007;35:S106 S116.

The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deﬁciency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identiﬁed for Thrombate III. Please see brief summary of Thrombate III complete Prescribing Information on adjacent page. Reference: 1. Thrombate III® (antithrombin III [human]) [prescribing information]. Research Triangle Park, NC: Grifols Inc; 2012. © 2013 Grifols Inc.

February 2013

TH05-0113

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A Vitamin for the Lungs Thiamine may improve ventilation in the critically ill patient

hiamine, a vitamin important to aerobic metabolism, may improve oxygen extraction in critically ill patients, according to the results of a study presented at the 2013 annual meeting of the Society of Critical Care Medicine. The pilot study found that

administering thiamine intravenously to critically ill patients led to a significant increase in oxygen consumption (VO2). The overall increase remained statistically significant after researchers adjusted for the patients’ Cardiac Index (CI) scores. The intervention was more effective in patients with

THROMBATE

III®

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

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

higher CI scores than the mean, and nonexistent in patients with lower CI values. Baseline thiamine levels did not appear to affect the results. “Although we cannot draw any conclusions about clinical significance based on this very small pilot study, our findings suggest that we may be

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

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

08941115-BS

able to improve oxygen extraction in the critically ill,” said Katherine Berg, MD, a pulmonary disease and critical care specialist at Beth Israel Deaconess Medical Center, and instructor of medicine at Harvard Medical School, both in Boston, who led the study (abstract 915). “Pathologically low oxygen extraction is known to be associated with worse outcome in critical illness, so an intervention that improves oxygen extraction could potentially improve outcomes.” Researchers previously thought that increasing oxygen delivery (DO2) in order to raise VO2 would benefit patients, but further studies found the opposite to be true for those patients whose VO2 did not rise with DO2, suggesting that oxygen extraction plays an important role in helping these patients. Dr. Bergg and her team studied 16 patients admitted to the medical and surgical ICUs of Beth Israel, who were connected to mechanical ventilators. Researchers used the Cheetah noninvasive cardiac output monitoring system and the GE Compact Anesthesia monitor to establish baseline CI and VO2 data, then administered a single 200 mg dose of thiamine intravenously and monitored CI and VO2 levels for several hours afterward. On average, oxygen consumption increased by 16 mL/min. In patients with a CI higher than the mean for the group, the increase was even more dramatic, averaging 71 mL/min. However, in patients with low CIs, thiamine had no effect. The patients’ initial thiamine level was not related to the results. The findings are potentially promising for the treatment of critically ill patients, said Gerald Maccioli, MD, a physician at Duke Raleigh Hospital and chair of the committee on quality assurance and performance measures at American Anesthesiology of North Carolina. “It’s very interesting from both a clinical and a cost-benefit perspective,” Dr. Maccioli said. “Thiamine is dropdead cheap, so if this intervention could reduce ICU length of stay, the cost-benefit ratio would be fantastic.” However, Dr. Maccioli also said he would like to see the study repeated with more precise tools for monitoring CI and VO2. “If you want a quick snapshot, it’s fine; but if you really want to measure VO2, a metabolic

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

Light Troponin ‘Leak’ Linked To Increased Mortality in Critically Ill

raditionally considered irrelevant below a certain threshold, minor elevations of troponin without a diagnosis of acute myocardial infarction—informally known as “troponin leak”—may be more significant than previously thought in critically ill patients, according to the results of a study presented at the 2013 annual meeting of the Society of Critical Care Medicine. The study found minor troponin elevations to be associated with substantially higher rates of both short-term and long-term mortality (abstract 846). Elevations between 0.01 and 0.09 ng/ mL were linked to a 19% higher rate of 1,000-dayy mortality. (For reference, a diagnosis of acute coronary syndrome calls for a troponin elevation of 0.1 ng/mL.) Patients with minor troponin elevations were found to have a 36% higher risk for death at 30 days from admission than those without the elevated marker. The association remained significant after researchers adjusted for a host of potential confounding factors, including age, sex, comorbidities and severity of illness. “The findings suggest that minor troponin elevation represents an inherent patient variable that is not captured by chronic medical comorbidities,” said Adrian Velasquez, MD,

cart is a far more precise and accurate instrument,” Dr. Maccioli said. “And if one of the end points of the study is oxygen consumption, I think it is imperative that you use the measurement tool that is most precise for that end point.” Dr. Bergg emphasized the preliminary nature of the results. She said her team did its best to exclude patients with conditions that could have changed the results, but was not able to adjust for all potential confounding variables because of the small size of the study. “The findings certainly should not alter practice at this point, but future studies are planned to see if we can validate our findings,” Dr. Bergg said. “We plan to proceed to a randomized, placebo-controlled trial looking at the effect of thiamine versus placebo on VO2 in a similar patient population.” —Ajai Raj

a fellow in critical care and internal medicine at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., who led the study. “Our point is we should not disregard this in prognosticating short-term and long-term mortality.”

Troponin is a protein that the heart produces when it is overworked. A blood troponin level above 0.1 ng/mL is a marker for acute coronary syndrome, but the implication of lower levels for the health of patients in intensive care had not

been studied before. Using the Multiparameter Intelligent Monitoring for Intensive Care (MIMIC II) database, a specialized resource developed and maintained by the Laboratory of Computational Physiology at the see troponin page 32

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from ARDS and who already has a 40% to 50% chance of dying in the hospital?” the development of lung dysfunction and Mark Looney, MD, associate professor of medicine at the University of organ failure. They also reinforce preclinical research indicating improved outcomes California, San Francisco, told Anesthefrom antiplatelet therapy administered to siology News that “more basic science patients shortly after trauma and hemorwork is needed to determine the mechrhagic shock. anisms by which antiplatelet agents are “Antiplatelet therapy may have a signifipotentially protective in trauma and cant beneficial effect on acute respiratory acute lung injury, including determining distress syndrome [ARDS], multiple organ whether the protection is common to all failure [MOF] as well as other outcomes in antiplatelet agents or perhaps restricted trauma patients who receive multiple transto just aspirin.” Dr. Looneyy has investifusions,” said Jeffrey Harr, MD, MPH, of gated the effects in mice of aspirin treatthe Department of Surgery at the Univerment on platelet depletion following transfusion-related acute lung injury (J ( sity of Colorado Trauma Research CenClin Investt 2009;119:3450-3461). He ter, in Denver, and lead author of the study. “There have been several preclinical studies was not involved in this study. showing the benefits of antiplatelet therDr. Harr said he believes there is now apy in transfusion-associated lung injury, sufficient evidence to begin prospecbut clinical data remain lacking. Our study tive clinical studies in giving trauma patients antiplatelet therapy early followis the first to show these clinical benefits in accompanying the journal article (Crit Care Med ing injury. “Trauma patients commonly present with trauma patients,” Dr. Harr told Anesthesiology News. The study compared outcomes of 839 patients 2013;41:659-660). advanced coagulopathies, including platelet dysfuncDr. Papadakos, an Anesthesiology News editorial tion, which cautions the premature use of antiplateat nine trauma centers from 2001 to 2008 who were prospectively enrolled in the Inflammation board member, said that although pharmaceutical let therapy,” Dr. Harr said. “However, these same and Host Response to Injury, a project funded by a companies have little interest in supporting addi- patients develop a hypercoagulable state within 72 grant from the National Institute of General Med- tional clinical studies, meta-analyses of previous hours of injury. Therefore, in select patients, early ical Sciences. Of the 839 patients, 128 (15.3%) had studies should be performed. And if the National administration of antiplatelet therapy may not only been taking acetylsalicylic acid, another antiplatelet Institutes of Health were to support large population reduce the risk for ARDS and MOF, but may also agent—including clopidogrel or ticlopidine—or a studies in this area, new government-supported trials have a role in decreasing post-injuryy venous thromboembolic events.” combination of aspirin and another drug before sus- might follow. However, he asked, “What is the downside of givtaining their injuries. After adjusting for age, sex, comorbidities and ing 81 mg of aspirin to a critically ill patient dying —Ted Agres other possible confounding characteristics, the researchers found that 58% of the patients who received antiplatelet treatment experienced lung dysfunction compared with 64% of the others (P=0.23). Similarly, they found that 17% of patients taking TROPONIN CONTINUED FROM PAGE 31 antiplatelet medication experienced multiple organ Massachusetts Institute of Technology, Dr. Velasquez said. “They decided to look at troponin elevations in failure compared with 21% of the others (P=0.37). And although the patients who had been taking and his team gathered data on more than 3,200 a greater context and said, ‘Do these troponin elevaantiplatelet medication were older and more severely patients from four ICUs at the Beth Israel Deaconess tions signify that there’s something else bad going on injured, they received a similar volume of blood Medical Center, in Boston: the medical, surgical, cor- that could put the patient at risk?’” products and were less likely to require a massive onary care and cardiac surgery recovery units. What they found, he said, is “not confirmatory eviDr. Velasquez said that the results, while sta- dence, from a strict scientific perspective, but intertransfusion (defined as more than 10 units of packed red blood cells; 17.2% versus 27.7%; P=0.01). The tistically significant, are not without limitations. esting evidence nonetheless,” that elevated troponin two groups experienced roughly identical rates of Although his team adjusted for most potential con- levels are associated with heart damage and higher mortality—20% versus 21%, respectively (P=0.71). founding variables, the tools at their disposal did mortality rates. not allow them to account for the role the kidneys But what remains to be answered, and what Age Equalizer? might play in elevated troponin levels. The kidneys Dr. Nunnallyy said researchers should focus on next, All this is surprising, Dr. Harr said, because prior clear troponin from the blood of healthy patients; is what might be driving the increases in troponin— studies had found that older people with multiple impaired kidney function, rather than coronary dys- which may include myocardial infarction but also comorbidities tend to have worse outcomes, includ- function, might therefore account for the elevation other phenomena such as embolism, insufficient blood ing ARDS, MOF and mortality following trauma. of troponin in some of the patients studied. supply to the heart or excessive cardiovascular stress. Even if they do not establish causation, the results “However, these data suggest that older patients with In the meantime, he said the results, although not more comorbidities on antiplatelet therapy had of the study demonstrate a “fairly clear correlation” revolutionary, are worth heeding. “It’s a bit of a confirmation of a clinical suspicion,” similar outcomes to healthier individuals with no that should be investigated further, said Mark Nunincreased bleeding complications or increased trans- nally, MD, chair of the Committee on Critical Care Dr. Nunnallyy said. “But it should cause us all to be fusions,” Dr. Harr said. Medicine for the American Society of Anesthesiol- more cautious. We have long suspected troponin ele“It is fascinating that such an old and cheap class ogists and professor of anesthesia and critical care at vations would be a sign of something bad, but since of medications may play an important role, as the University of Chicago. He added that troponin, there was confusion about their meaning, it wasn’t they have in cardiovascular disease, in the manage- hailed at the time of its discovery as a factor to lend clear how to use the information. This study doesn’t ment of one of the major problems in massive blunt clarity to the diagnosis of myocardial infarction, in clarify the situation completely, but perhaps takes us trauma, ARDS and MOF,” wrote Peter J. Papada- fact has done anything but that. a step closer.” kos, MD, professor of anesthesiology at the Uni“What’s interesting about this study is that the versity of Rochester, in New York, in an editorial authors sort of took a different track,” Dr. Nunnally —Ajai Raj CONTINUED FROM PAGE 1

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

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Consider Continuing Low-Dose Aspirin Closer to CABG Miami Beach, Fla.—Perioperative aspirin can confer a protective effect following bypass surgery, but little is known about the optimal timing and dosage. “In the context of cardiac surgery, patients who are taking aspirin therapy preoperatively fare better in terms of decreased morbidity and mortality than patients who don’t,” said Paul

Pisklak, MD, cardiac anesthesia fellow at the Texas Heart Institute, in Houston. “Given that we know that much, the optimal dosage timing of the last dose of aspirin before surgery has not been clearly delineated.” All 2,634 participants in the study underwent isolated coronary artery bypass graft (CABG) surgery at Texas Heart Institute between July 2005 and

May 2011. Those who took their last aspirin dose within 24 hours before surgery reduced their risk for 30-day allcause postoperative mortality by 57% compared with patients who did not take aspirin so soon before surgery or at all (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.21-0.90; P=0.02). The retrospective cohort study was presented at the 2013 annual meeting of

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the Society of Cardiovascular Anesthesiologists (abstract 6). “When you look at patients who take aspirin within 24 hours compared with those who don’t take it within 24 hours, the 30-dayy mortality is roughly half,” Dr. Pisklakk said. All-cause mortality following on-pump CABG was 1.5% among the 1,093 patients who took aspirin so close to surgery versus 2.9% among the 1,541 who did not (P=0.02). “We looked at 48 hours and 72 hours the same way,” Dr. Pisklakk said. “The significant results were only within a 24-hourr window.” Although Dr. Pisklakk acknowledged that the findings were “not in any way definitive,” he noted that the conventional approach is to hold aspirin for seven days before CABG surgery. “We might want to reconsider that,” Dr. Pisklakk said. “It looks like the benefits outweigh the risks, specifically with the 81 mg dosage.” In other words, he said, clinicians should not simply tighten the timing, but also should consider dosage. Interestingly, in a multivariate analysis only 81 mg per day of aspirin conferred a significant decrease in mortality compared with no aspirin therapy (OR, 0.37; 95% CI, 0.17-0.78; P<0.01). In contrast, patients on 325 mg of aspirin received no mortality benefit (OR, 0.89; 95% CI, 0.45-1.73; P=0.7) compared with the no-aspirin group. The rate of allcause 30-dayy mortality was 1.6% in the 81-mgg group, 2.7% in the 325-mg group and 3.5% in those not taking preoperative aspirin. “It might be a little counterintuitive, but our best guess is any benefit with 325 mg aspirin might be outweighed by possible risk for increased bleeding, but we didn’t specifically look at that,” Dr. Pisklakk said. The researchers were unable to perform a direct comparison of mortality between the 81-mgg and 325-mgg groups, Dr. Pisklakk said. James H. Abernathy III, MD, MPH, associate professor of anesthesia and perioperative medicine at the Medical University of South Carolina, in Charleston, who moderated the session, said, “It would be really interesting to see less than 24 hours [administration] of 81 mg versus 325 mg.” Dr. Pisklakk agreed: “It would have been a nice way to tie this all together, but unfortunately, the numbers were not there.” —Damian McNamara

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Q. What types of configurations are available with the FlexTip Plus Multi-Port epidural catheter? A. The FlexTip Plus Multi-Port epidural catheter is available in a variety of kit and set

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The Tricky Business of Treating Massive Hemorrhage Las Vegas—When choosing the best treatment for trauma- or surgeryrelated bleeding, clinicians should know their pathophysiology and the pros and cons of each agent, according to a presentation at the American Society of Health-System Pharmacists 2012 Midyear Clinical Meeting. “It amazes me how frequently I bring up the topic during rounds and find clinicians are unfamiliar with many of the causes, mechanisms and treatments for massive bleeding,” said presenter Rob MacLaren, PharmD, associate professor at the University of Colorado School of Pharmacy, in Aurora. The primary goal of treating traumarelated bleeding is to prevent the depletion of thrombin, Dr. MacLaren explained. “Trauma and shock lead to a release of large amounts of thrombin, which then binds to thrombomodulin, which is actually an anticoagulant,” he said. “On top of this, trauma patients often receive large volumes of resuscitative fluids that further dilute endogenous clotting factors and increase bleeding.” Given this and other risks associated with large volumes of resuscitative fluids, Dr. MacLaren recommended administering 2 L of crystalloid fluids “as soon as you can” and observing the

patient’s response. If vital signs do not quickly return to normal, he recommended adding more crystalloid fluid and considering the patient for transfusion and surgery. Before administering blood products or drugs, clinicians should ensure that other risk factors for mortality are under control. Most critically, minimize the risk for hypothermia, acidosis and dilution, he said. Because patients

with this “lethal triad” have a 95% risk for death (Crit Care 2006;10:222), trying to control these should be a priority, Dr. MacLaren said.

said this decision should not be made lightly. “All blood products are associated with a risk of acute lung injury, infections and organ failure and are, therefore, not benign,” he said. Blood Products Bearing these complications in mind, Are ‘Not Benign’ each blood product has its advantages Once these risk factors are evaluated and limitations, Dr. MacLaren said. and, ideally, controlled, clinicians can For example, cryoprecipitate increases consider transfusion of a blood prod- fibrinogen levels but does not reduce a see hemorrhage page 44 uct (Table 1). However, Dr. MacLaren

Table 1. Blood Products Used in Patients With Hemorrhage Product

Contents

Indication(s) and Dose(s)

Concernsa

Platelets

Thrombocytes in plasma

Bleeding: Platelet <50 x 109/L Prevention: Platelet <20 x 109/L

Stored at 20°-24°C Bacterial contamination ~1/2,000-1/3,000 units Worsens immune reactions

Fresh frozen plasma

Coagulation factors and fibrin- INR ≥1.5: 15 mL/kg ogen in variable amounts (~30% factor replacement)

Prothrombin complex concentrates (Bebulin, Baxter; Profilnine, Grifols)

Factors II, VII, IX, X and prothrombin, proteins C, S, Z in variable amounts

INR ≥1.5: 25-50 IU/kg (based on factor IX)

Variable amounts of factors May contain heparin Numerous donors Costly

Cryoprecipitate

Factors VIII, XIII, vWF, fibrinogen, fibronectin

Fibrinogen <100 mg/dL: 1 unit will fibrinogen ~5-10 mg/dL vWF deficiency

Variable amounts of fibrinogen Costly

Cryosupernatant

Not factor VIII, vWF, and minimal fibrinogen

TTP

Costly

Requires thawing Hypervolemia

INR, international normalized ratio; TRALI, transfusion-related acute lung injury; TRIM, transfusion-related immunomodulation; TTP, thrombotic thrombocytopenia purpura; vWF, von Willebrand factor a

All products are associated with thrombotic events, TRALI, TRIM, infection transmission and febrile reactions.

Based on Pharmacotherapy pyy 2007;27(9 Ptt 2):57s-68s 2):57s 68s and Pharmacotherapy pyy 2007;27(9 Pt 2):69 2):69s-84s. 9s 84s.

‘Walking’ Epidural Reduces Rate of Cesareans With No Loss of Pain Relief New York—Using lower concentrations of ropivacaine for continuous epidural patient-controlled analgesia with ambulation at earlier cervical dilation provides adequate pain relief with less hypotension, motor block and bladder catheterization, as well as lower rates of cesarean deliveries, researchers have found. The study, by a team from the University of Medicine and Dentistry of New Jersey (UMDNJ) Robert

Wood Johnson Medical School, compared the “walking” epidural—consisting of ropivacaine (Naropin, APP) 0.04%, 1 mcg/mL of sufentanil and 2 mcg/mL of epinephrine—to the hospital’s typical, patientcontrolled regimen of nonambulatory epidural anesthesia of ropivacaine 0.1%, 1 mcg/mL of sufentanil and 2 mcg/mL of epinephrine. The goal was to determine whether decreasing the concentration of ropivacaine, while permitting ambulation, in epidural

Table. Strong Against Pain, With Minimal Complications No Ambulation, n=420 (%)

Ambulation, n=420 (%) P Value

Total PCA volume/time (mL/min)

4.1±4.3

5.5±4.4

<0.05

Initial cervical dilation, ≤3

201 (48)

278 (66)

<0.01

Pruritis

224 (53)

349 (83)

<0.01

Pruritis Rx

61 (14.5)

278 (66)

<0.01

Hypotension

44 (10.5)

4 (0.9)

<0.01

Bladder catheter

187 (44.5)

113 (27)

<0.01

Motor block (modified Bromage score <6)

145 (34.5)

14 (3.3)

<0.01

patient-controlled analgesia (PCA) could reduce side effects and improve maternal labor and delivery outcomes. The randomized trial included 840 patients. Those in the ambulatory group were allowed to walk only if they had a modified Bromage score of mobility below 6. The researchers found no statistically significant difference between the two groups with regard to total infusion time, but they did observe a significant difference in terms of the total volume of PCA infused during delivery, with the walking group requesting more analgesia (2.7 PCA attempts per minute compared with 2.35 in the nonambulatory group; P<0.05) Overall, however, patient satisfaction with analgesia was similar for both groups. Most notably, only four of the patients who received a walking epidural experienced hypotension compared with 44 patients in the nonambulatory group. Only 113 in the walking group required bladder catheterization compared with 187 in the nonambulatory group. Motor block was seen far less frequently in the see epidural page 44

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The Truflex™ Flexible Tip Stylet, From Truphatek Q. What is the Truflex™ flexible tip stylet? A. Truflex is a unique flexible tip stylet that can be flexed in a vertical direction, to an angle of 30 to 60 degrees by using light handle pressure. Using the Truflex stylet, the anesthetist can easily control the direction of the endotracheal tube (ETT) tip and thereby circumvent the cricopharyngeal muscle, enabling an easier intubation in the most difficult of cases.

Q. How do you clean, disinfect and sterilize the Truflex flexible tip stylet? A. Cleaning: Immediately after use, the Truflex stylet should be rinsed in running water under the tap and cleaned using a soft brush to avoid any encrusted deposits. Disinfection: Truflex is compatible with treatment using thermal disinfectors according to the manufacturer’s guidelines

for recommended exposure times and solution strengths. Note—chemical sterilants containing caustic ingredients should not be used. Sterilization: Truflex may be autoclaved up to a maximum temperature of 138 C or as per manufacturer’s recommended temperatures and time instructions. Truflex is suitable for sterilization by ethylene oxide and STERRAD 100NX Standard Cycle plasma systems.

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Q. What size of ETTs can be used? A. The Truflex stylet can be inserted into ETTs of between 6.5 and 8.5 mm in diameter. It has a stopper that can be moved into various positions, locking the different lengths of ETTs into place during the actual intubation, yet allowing the physician to easily pull the stylet from the ETT.

Q. Are there any special warnings associated with the product? A. The tip of the Truflex stylet should never be extended beyond the eye of the ETT and the Truflex stylet should be removed from the ETT before the tube is advanced into the vocal cords. Truphatek’s Truflex stylet must be thoroughly cleaned and sterilized after every use.

Q. How many times can the Truflex Stylet be used? A. The Truflex flexible stylet is a reusable device manufactured from medical grade 304/316L stainless steel. It is therefore indestructible. The Truflex stylet has been tested to withstand more than 100 repeated cycles of STERRAD plasma systems and is guaranteed to be of good quality and free from manufacturing defects in material and workmanship for a period of 12 months from date of manufacture, as marked on the product.

“The Truflex™ Stylet is an excellent too tool to facilitate intu intubation success w with either dire direct or indirect lar laryngoscopy.” Carin A. Hagberg, M.D. Joseph C. Gabel Professor and Ch hair UTHealth | The University of Texas xas Health Science Center at Houston Medical School Department of Anesthesiology Anesthesio ology Houston, Texas, USA

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Researchers Probe Causes of Opioid Infusion Errors in Peds Study highlights importance of standards, particularly for transfers, in pain care

lthough potentially critical incidents occur regularly during opioid infusions in children, such events typically involve minor errors in the administration of the drugs, Canadian researchers have found. Interestingly, the researchers found that the overwhelming majority

of incidents occurred in children being treated by clinicians in the acute pain service. “When I took over as director of the acute pain service here, I realized we needed to make changes, partly in response to some incidents that had occurred and partly through wanting

to understand if patients not being managed by the pain service were having adequate analgesia,” said Gillian Lauder, MD, clinical associate professor of anesthesiology, pharmacology and therapeutics at the University of British Columbia, in Vancouver. The result of this realization was the

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current study, in which Dr. Lauderr and her colleagues analyzed patient safety and pharmacy data for potential critical incidents in patients receiving parenteral opioid infusions, between December 2004 and December 2009. The incidents were graded on their severity and the probability of recurrence. Those that scored at least an 8 out of 10 were selected for root cause analysis. The researchers identified 166 potential incidents. “There was no evidence of a relevant incident in 108 of them,” Dr. Lauder told Anesthesiology News. The 58 remaining charts included one (n=45) or more (n=13) relevant critical incidents. The most common incident was opioid administration error, which affected 39 cases (67%), according to the investigators, who presented their findings at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1341704). Fourteen charts were selected for root cause analysis, which identified 31 root causes. The most frequent and significant ones involved defective preprinted order sheets for opioid infusions; lack of nursing guidelines for the infusion adjustment rate and weaning off the medication; and inadequate policies and guidelines for monitoring and recording pain, vital signs and arousal. Generally, the root causes were classified as policies/procedures/rules (49%), communication (13%), environment/equipment (17%) and training (21%). “We couldn’t really analyze fatigue and scheduling because [the study] was retrospective,” Dr. Lauder said. “So, we ended up looking at the four above categories and got information about things we could change in the system.” One problem that the group identified was the transfer of patients between units. “At that time, we didn’t have standard policies and procedures for our opioid infusions and we didn’t have standard opioid concentrations,” she said. “So, if a patient was transferred between units, there was a greater chance an incident could occur.” The researchers have used the analysis to generate a series of recommendations for improving patient safety and the quality of analgesia for children with acute pain. These recommendations include: 1) promoting uniform see errors page 42

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

Side Effects of Opioids Worse for Girls Than for Boys Findings suggest sex difference not related to hormones

irls are more likely than boys to experience adverse effects of morphine during and after tonsillectomy, among whites, Ohio researchers have found. The findings add to existing evidence that many variables can affect an individual’s response to anesthesia. “We know that race and genetics are important factors in determining postoperative pain and opioid-related outcomes, but there is no literature on differences between girls and boys,” said Senthikumar Sadhasivam, MD, MPH, principal investigator of the study and director of the perioperative pain service at Cincinnati Children’s Hospital. “We wanted to include all factors, genetic and non-genetic, to assess an individual child’s underlying risk and accordingly tailor therapy.”

‘This shows us that children are not small adults, and they differ in their responses to pain and pain medications.’ —Senthikumar Sadhasiam,

such as respiratory depression and PONV. Girls also had longer stays in the PACU, according to the researchers. “White girls had more side effects with increasing doses of morphine than white boys following tonsillectomy surgery,” Dr. Sadhasivam said. “We earlier reported [Pediatrics

2012;129:832-838] that Caucasian children have more opioid-related adverse effects and African-American children have inadequate pain relief despite receiving higher doses of morphine during and after tonsillectomy.” The size and population demographics of the study precluded the analysis

of race as an additional variable in opioid-related outcomes, thus limiting the study to white participants. Women are known to have more opioid-related side effects than men, and the difference had been assumed to be hormonally mediated. This study, see side effects page 42

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The researchers recruited 275 children between the ages of 6 and 16 years to participate in the study. All subjects received a standard dose of intraoperative morphine (0.1-0.2 mg/ kg) and their postoperative pain and opioid-related outcomes were assessed, including postoperative nausea and vomiting (PONV), respiratory depression and prolonged stays in the postanesthesiaa care unit (PACU) resulting from adverse effects related to opioids. “Some children require more morphine than others, and we wanted to study who is at higher risk of excessive opioid-related adverse effects and inadequate pain control in the recovery room,” explained Dr. Sadhasivam, whose group presented its findings at the 2013 annual meeting of the Society for Pediatric Anesthesia (SO2-149). Dr. Sadhasivam and his colleagues found that as the total dose of morphine administered during and after tonsillectomy increased up to 0.4 mg/ kg, girls had about a twofold to threefold higher rate of major adverse effects,

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Is MILD Ready for More Action? A Pro–Con Debate At the fall meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA), experts debated whether the Minimally Invasive Lumbar Decompression (MILD) procedure is ready for a major role in interventional pain medicine. PRO

CON

Nagy Mekhail, MD, PhD

Samer Narouze, MD, PhD

s MILD ready for more widespread use? Is this a procedure I would like to have someone perform on me if I had neurogenic claudication? Based on the body of evidence available, I would say yes. Laminectomy is the best treatment to decompress a compromised spinal canal, especially for patients with severe spinal stenosis. But success comes at a price. The overall incidence of complications from surgery and general anesthesia can be as high as 10%.

within six months. It is clear from these findings that MILD is durable. We also recently reported a series of 40 consecutive patients with neurogenic claudication treated with 90 MILD procedures at the Cleveland Clinic Pain Program (Pain Pract 2012;12:417-425). Pain Disability Index scores improved by 40% and the Roland-Morris Disability Questionnaire scores improved by 50%. What is fascinating is the time patients were able to stand increased from seven to 90 minutes over one

‘The aim of laminectomy is to debulk the ligamentum flavum, allow more room in the spinal canal and alleviate patients’ pain. MILD does this with a great likelihood of preserving the integrity of the spine compared with laminectomy or fusion.’ This is one reason why the MILD procedure warrants further evaluation. The aim of laminectomy is to debulk the ligamentum flavum, allow more room in the spinal canal and alleviate patients’ pain. MILD does this with a great likelihood of preserving the integrity of the spine compared with laminectomy or fusion. The majority of published MILD studies are positive. For example, my colleagues and I performed a prospective, multicenter study of MILD (Pain Practt 2012;12:184-193). Available data for 58 participants support long-term pain relief (based on patient-reported visual analog scale [VAS] ratings) and improvements in functionality (based on Oswestry Disability Index [ODI] scores). Seventeen patients were lost to follow-up. The study was initially planned for six months and later extended. After one year, 79% of patients achieved pain reduction with an average VAS score decrease of 4 points. At the same time, the average ODI scores improved by 16 points. Only six patients underwent laminectomy

year; at the same time, walking distance significantly improved from 300 to 4,500 feet. Importantly, spinal canal stenosis is multifactorial and we assessed patients for comorbidities. Despite what we considered proper patient selection, about 30% had some element of radiculopathy. Training and patient selection are essential. Most failed cases occur in poorly selected patients. It’s very important to make the distinction between lumbar neurogenic claudication and radiculopathy, using imaging to confirm the clinical diagnosis— magnetic resonance imaging can show if a hypertrophic and thickened ligamentum flavum takes up a significant portion of the spinal canal. In a selected patient population, MILD is a great technique to relieve pain and improve quality of life. Dr. Mekhail is professor of anesthesiology at the Cleveland Clinic Lerner College of Medicine in Ohio and is jointly appointed at the Cleveland Clinic Spine Center and Cleveland Clinic Cancer Center. He had no relevant financial disclosures.

ILD is really a noble idea, but it’s drawing many concerns. The New York Times picked up on some of the controversy in its Sept. 5, 2012 article, “Clash Over a Spine Treatment.” The article addressed a study of 10 patients followed 26 weeks after undergoing the MILD procedure (Neurosurgery 2012;71:86-92). One of the co-authors, Daryl Fourney, MD, reported that many patients returned for surgery when he followed them beyond the end of the study protocol (neurosurgerycns.wordpress.com/2012/10/16/ response-letter-to-the-editor-regardingfailure-off percutaneous-remodeling-forneurogenic-claudication/). This upset the manufacturer, and there was a nasty chain of letters to the editor responses back and forth.

But there is no way to tell how much ligamentum flavum contributes to the stenosis without the use of “dynamic” MRI. Additionally, there was no comparator group—and 50% of patients might do better anyway over time. We should compare MILD with other minimally invasive procedures. The first study to assess MILD was the MiDAS I (Mild Decompression Alternative to Open Surgery) study (Pain Physician 2010;13:369-378). The 75 patients were only followed for six weeks. There is no mention as to whether the surgeon injected epidural steroid at the same time. Dr. Mekhail’s multicenter study (Pain Practt 2012;12:184-193) is actually the MiDAS II trial. There was no mention of the 17 patients who dropped out. Other limitations

‘I think there was some rush to build data in the literature for MILD. … We need data from other, independent groups.’ I cannot agree more with Dr. Mekhail that optimal use of the MILD procedure all comes down to patient selection and proper training. Dr. Mekhail and his associates concluded that MILD is the first choice to treat lumbar spinal stenosis after conservative management. I disagree. It’s an option for the correct patient. MILD should only be offered to patients with symptomatic central stenosis when magnetic resonance imaging (MRI) clearly shows it is only or mostly caused by ligamentum flavum hypertrophy. Patients should be made aware that MILD will not help their back pain or their radicular symptoms. Don’t get me wrong. I do this procedure maybe once or twice a month. Over the past three years I have had maybe 25 or 30 [MILD] patients. Most of them are doing well, but I am very, very selective. The ligamentum flavum has to be very bulky. Dr. Mekhail and his associates mentioned that the ligamentum flavum contributes up to 85% of spinal canal stenosis (Pain Pract 2012;12:417-425).

include no postoperative MRI to document the decompression and no mention of epidural steroid injections or other interventions during the year of follow-up. I think there was some rush to build data in the literature for MILD. As I noted in the ASRA newsletter last year, “Although the MILD procedure seems to be very safe and efficacious in selected patients, it is premature to recommend its widespread use in patients suffering from lumbar spinal stenosis without well-controlled studies comparing its outcomes with those of the more traditional open approaches” (www.asra.com/userfiles/ASRA_ August_2011.pdf ). We also have to compare MILD with other minimally invasive laminectomies. We need data from other, independent groups. Dr. Narouze is chairman of the Center For Pain Medicine at Summa Western Reserve Hospital in Cuyahoga Falls, Ohio, and clinical professor of neurological surgery at The Ohio State University.

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The following advertorial has been provided by ETView and is designed to support the advertisement presented below.

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The VivaSight Portfolio, From ETView Q. What are the main indications for using VivaSight portfolio products? A. VivaSight portfolio products provide the surgical team with next-generation airway management required for a range of lung isolation procedures.

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

CONTINUED FROM PAGE 38

® MAQUET is a regis stte tered trademark of MAQUET GmbH. 2011 Co op pyright MAQUET Cardiova ascular LLC or its aff affiliates. All rights reser ved. Caution: U.S. Fede erra al Law restricts this device to sale by or on th he order of a physician. Re efer to Instructions for fo Use for current indications, warn nings, cont ntraindications, and precautions.

hospital-wide monitoring, documentation and policies related to opioid administration, opioid weaning and opioid conversion in children transferred to and from the pediatric intensive care unit; 2) enhancing education in pediatric acute pain management for residents and other health care professionals to include an awareness of the pharmacokinetic variability of opioid medications in children; and 3)

promoting the timely involvement of the acute pain service. “Fortunately, we now have standard concentrations, preprinted orders, and nursing policies and procedures that span the entire hospital,” Dr. Lauder said. “I think the next thing to do would be to make sure that all incidents have root cause analyses performed prospectively.” Conor McDonnell, MD, director of safety and quality in the Department of Anesthesia at The Hospital

for Sick Children in Toronto, Canada, said the findings help confirm previous research into medication errors in children. “One of the things we uncovered in some of our work is that administration errors definitely seem to be an issue, particularly around the time of handovers and patient transfers,” Dr. McDonnell told Anesthesiology News. Indeed, Dr. McDonnell and a colleague, in a study published last year, Pediatrics (2012;129:916-924),

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examined 10-fold medication errors in children. “When it came to opioid infusions, we found several common causes, including incorrect equipment programming, programming multiple infusions and distractions during tasks,” he said. “And when you added paperbased ordering in the intensive care unit, it became extremely problematic.” Dr. McDonnell also found common ground in the potential for errors to occur when patients are transferred between units. “My experience is that our ICUs have different methods for ordering medications and making up concentrations and infusions, so it can create a lot of inconsistency when patients are transferred out again. As a result, we have also moved to things like standard concentrations and preprinted order sets for our acute pain service around the hospital.”

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however, showed a trend that prepubertal younger girls were more likely to experience side effects than girls over the age of 9 years. “This questions the whole thought process we have,” said Sabine KostByerly, y MD, director of pediatric pain management at Johns Hopkins Hospital, in Baltimore, and chair of the Society for Pediatric Pain Medicine. “Now, they have to look at why these girls would have higher rates of adverse effects from opioids.” The finding further pointed to the need for more clinical studies in pediatric pain management. “This shows us that children are not small adults, and they differ in their responses to pain and pain medications,” Dr. Sadhasivam said. “This was a surprising finding.” The team is currently studying other potential mechanisms to explain this finding, and a multicenter study is under way to validate the results. “We need to validate our findings in other races/ethnicities and other studies. Once validated, [the] sex of the child will be included in the model predicting risk and personalizing opioid doses,” Dr. Sadhasivam said. “All of this is really trying to understand how analgesia works, how we can avoid adverse events and how can we get optimal analgesia after surgery,” Dr. Kost-Byerlyy added. “This is another piece of the puzzle in developing individualized pain management for patients.” —Keely Savoie

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

Fluid Overload Linked to Mortality After Cardiac Surgery in Peds

arly postoperative fluid overload in children undergoing cardiac surgery is significantly associated with increased risk for death, researchers in Hungary have found. Each 1% increase in the severity of the overload was linked to a 14% increased likelihood for death on the day of surgery, according to the investigators. The association was limited to the first 24 hours, however, said the researchers, who reported their findings at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 806). This study included 1,520 consecutive pediatric patients undergoing cardiac surgery at Semmelweis University, in Budapest, between January 2004 and December 2008. “We found in a retrospective analysis that fluid overload is independently associated with mortality after cardiac surgery, after adjustment for other perioperative variables,” lead investigator Andrea Székely, MD, told Anesthesiology News. A total of 55 patients (3.6%) died in the hospital. Children who survived had significantly lower fluid balance on the day of surgery ((P<0.006) and on the first postoperative day (P<0.001) than those who died, after controlling for demographic and intraoperative variables. The adjusted odds ratio (OR) for fluid overload and in-hospital mortality on the day of surgery was 1.14 (95% CI [confidence interval], 1.04-1.25; P=0.004). On the first postoperative day, this association remained significant (adjusted OR, 1.15; 95% CI, 1.04-1.27; P=0.009). However, a multivariate analysis showed that on the second postoperative day, fluid balance was not significantly associated with the risk for death. These results underline the importance of standard perioperative fluid balance monitoring for pediatric cardiac surgery patients, as well as early correction of any detected fluid overload, Dr. Szekelyy said. “Maintenance of strict fluid, electrolyte and glucose balance and early initiation of dialysis are the main goals of the optimal fluid management.” Measures of urine output and blood loss were not significantly related to increased risk for death in the study. Hemodynamic instability and acute kidney injury are additional risks associated with fluid overload in critically ill pediatric patients. Daily fluid balance in the first 72 hours after surgery

was calculated as a percentage equal to the fluid in minus fluid out (in liters) divided by patient admission weight in kilograms multiplied by 100%. Based on the findings, Dr. Szekely and her colleagues modified the glucose content and sodium content of the solutions at their institution. “We apply more strict fluid management in the first 72 hours,” he added.

“The authors are to be congratulated on this large retrospective analysis of the relationship between fluid overload and increased mortality in pediatric cardiac surgery patients,” said Nina Guzzetta, MD, assistant professor of anesthesiology at Emory University School of Medicine, in Atlanta, who specializes in pediatric cardiovascular surgery.

“Pediatric cardiopulmonary bypass is known to lead to some degree of fluid overload in the early postoperative period,” said Dr. Guzzetta. “Ideally, their retrospective study will generate future prospective trials designed to determine whether prevention or early correction of postoperative fluid overload can improve outcomes.” —Damian McNamara

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M AY 2 0 1 3

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

utility in the surgical setting, where it of Arizona’s College of Pharmacy, in could allow clinicians to tailor theraand ε-aminocaproic acid (EACA) can Tucson. However, he said advances pies, rather than using a one-size-fits-all patient’s international normalized ratio be used interchangeably to prevent and in thromboelastography (TEG)—a approach, but better evidence is needed (INR); platelets and red blood cells treat massive blood loss. method of testing clotting efficiency before it can be routinely used in setThe myriad considerations involved that is used primarily in the surgery settings such as trauma.” can worsen the immune response; and prothrombin complex concentrates in choosing a treatment for these types ting—may yield better decision mak—David Wild and fresh frozen plasma (FFP) can of bleeds make the task a tricky one, ing. “TEG-directed therapy may allow lower INR levels but not below the commented Asad Patanwala, PharmD, for specific coagulation abnormalities Drs. MacLaren and Patanwala reported no goal of 1.5 prothrombin time. “Fur- assistant professor at the University to be targeted,” Dr. Patanwalaa said. “It relevant financial conflicts of interest. thermore, large amounts of FFP may contribute to the development of encephalopathy and cerebral edema,” Table 2. Pharmacologic Agents Used in Patients With Hemorrhage he noted. Product Contents/Mechanism of Action Indications and Dose Concerns Dr. MacLaren discussed the features Cellulose-based To control or prevent oozing of May not adhere of several of the newer pharmacologic Local hemostatics Fibrin (human or bovine) ± blood at surgical site: Immune reaction, agents that have joined the mainstays fibrinolytic inhibitor ± aprotonin ± Dose depends on product infection transmission, for treatment of hemorrhage (Table 2). thrombin aprotinin use “Recombinant factors VIIa [rFVIIa] Thrombin (human or bovine) Immune reaction and VIIIa [rFVIIIa] are appealing Zeolite causes exothermic reaction Heat-induced tissue Chitason (chitin) activates platelets damage because they work downstream and and electrophysiologic endothelial May not adhere cause a thrombin burst,” he explained. attraction of RBCs “Therefore, they are more specific Cofactor for activation of factors INR ≥1.5:0.5-20 mg Slow-acting to the site of injury, and they don’t Vitamin K II, VII, IX, K Variable SQ absorption involve all the systemic activity of clotIV requires slow ting factors and platelets that the proadministration coagulant blood products need.” Recombinant factor VIIa Activates platelets to augment Refractory hemorrhage Short-acting Although rFVIIa reduces the use (NovoSeven, thrombin burst (surgery, trauma): Thrombosis (<10%) of blood products and lowers the NovoNordisk) 10-90 mcg/kg IV Costly risk for acute respiratory distress synRecombinant factor VIIIa Promotes fibrin crosslinking Extremely refractory Short-acting drome, possibly a result of the reduced (Advate, Baxter; Helixate hemorrhage (surgery, trauma): Thrombosis use of blood products, Dr. MacLaren FS, CSL Behring; 10-40 units/kg IV Costly noted, it does not actually reduce the Kogenate, Bayer; Requires refrigeration Recombinate, Baxter; incidence of mortality (Ann ( Intern Med 2011;154:529-540). Similarly, ReFacto, Wyeth) in the cardiac surgery setting, rFVIIa Desmopressin Selective V2 agonist to release Platelet dysfunction: Short-acting factor VIII, vWF and tPA 0.3 mcg/kg IV Tachyphylaxis and does not reduce mortality rates but bleeding risk with increases the rate of thromboembolic repeat doses events. “This agent should only be Conjugated estrogen antithrombin and protein S, Platelet dysfunction: Slow-acting used for refractory bleeding,” he said. factors VII, VIII, IX, X, prothrombin 25-50 mg IV Slow-offset Among the antifibrinolytics, tranexamic acid (TA) is a promising Antifibrinolytics Inhibit plasminogen proteases Prevention of surgical blood Thrombosis, and plasmin (aprotonin) and some loss, refractory hemorrhage: hypotension (TA) agent, he said, and data indicate that it (EACA, TA) anti-inflammation EACA: 150 mg/kg (10,000 mg), significantly reduces the risk for traumathen 15 mg/kg/h (2,000 mg/h) related death (Lancet ( 2010;376:23-32; TA: 10-30 mg/kg, then Lancett 2011;377:1096-1100). How1-16 mg/kg/h (<400 mg/h) ever, to prevent one death, 120 patients need to be treated, Dr. MacLaren said. EACA, ε-aminocaproic acid; INR, international normalized ratio; RBC, red blood cell; SQ, subcutaneous; TA, tranexamic acid; tPA, tissue plasminogen activator; vWF, von Willebrand factor 2007;356(2):2301 2311, Pharmacotherapy pyy 2007;27(9 Pt 2):93s-102s 2):93s 102s and Pharmacotherapy Pharmaccotherapy pyy 2007;27(9Pt2):69s-84s. 2007;27(9Pt2):69s 84s. He noted that TA might have greater Based on N Englg J Med 2007;356(2):2301-2311,

EPIDURAL

CONTINUED FROM PAGE 36

ambulatory group (14 vs. 145 patients in the nonambulatory group), and cesarean delivery was less common as well (53 vs. 65, respectively). On the other hand, patients who received walking epidurals reported more pruritus and required more interventions, as demonstrated by higher total PCA volume and use of rescue doses of ropivacaine. The duration of labor was unaffected. “Even with the benefits to the patient, walking epidurals are not used very often because they are more time-consumingg in terms of patient management,” said study leader Shaul Cohen, MD, professor of anesthesiology at UMDNJ, in New Brunswick. “It’s much easier to keep them in bed with a Foley

catheter. And it’s an insurance issue. Insurance companies pay for care not quality of care, and they won’t pay for the additional time and staff required by walking epidural.” Dr. Cohen added that the increased use of cesarean delivery—nearly 45% of laboring women in New Jersey now undergo the surgery, he said—makes it more difficult, if not impossible, for obstetric anesthesiologists to offer patients the walking epidural approach. Others in the field have a more tempered view of its benefits, however. “There is no ‘ideal’ epidural infusion regimen for labor analgesia,” said David Wlody, MD, chief of anesthesiology at the State University of New Yorkk Downstate Medical Center, in New York City, and a specialist in obstetric anesthesiology. “Different patients, anesthesiologists and

obstetric providers will have different expectations y a regarding pain relief in labor,” said Dr. Wlody, member of the editorial board of Anesthesiology News, who was not involved in the latest research. “Some patients may be willing to tolerate a greater amount of discomfort if it means enhanced ability to ambulate, while others will desire more pain relief at the expense of increased motor block,” Dr. Wlody added. “It is the responsibility of the anesthesiologist to balance these often conflicting goals in order to provide the best outcomes and the highest degree of patient satisfaction.” The researchers presented their findings at the 2012 PostGraduate Assembly in Anesthesiology (abstract 9028). —Brian Dunleavy

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AnesthesiologyNews.com I 45

CLINICAL ANESTHESI OLOGY

Exit Stage II? Researchers Question Component of 76-Year-Old Sedation Model

tage II is no longer a valid diagnosis for “stormy awakening” in modern anesthesia medicine, although it is still widely used and taught in medical school, according to a study presented at the 2012 PostGraduate Assembly (PGA) in Anesthesiology (abstract P-9046). Of course, stage II is one of the four stages of anesthesia initially described by Arthur Ernest Geudel in 1937. It often is referred to as the “excitement stage,” and is used to describe the period following loss of consciousness. However, a team of researchers led by Ram Roth, MD, assistant professor of anesthesiology at Mount Sinai School of Medicine in New York City, argues that evidence-based research indicates that pain, hypoxia, hypercarbia, preexisting states—such as obstructive sleep apnea—and residual paralysis should enter the differential diagnosis for difficult emergence. “Guedel developed the stages to help untrained personnel to deliver anesthesia with ether, which is a notoriously slow induction agent,” Dr. Roth told Anesthesiology News. “At the time, the treatment for the combative stage II was to deepen anesthesia faster. Today, we are well trained and use rapid induction inhalational agents, total intravenous anesthesia, paralytics, benzodiazepines, narcotics and a host of other drugs. We need to reexamine ‘stage II on emergence’ and find evidence for its existence or move beyond stage II toward improving quality of extubation and emergence by focusing on factors that we have evidence for.” For their study, Dr. Roth and his colleagues surveyed residents and fellows at a conference for their institution a few years ago. A total of 49 responded, including 10 clinical anesthesia (CA) year 1 residents, nine CA year 2s, 16 CA year 3s, and 14 postresidency anesthesiologists. In all, 44 of respondents said they had seen attending physicians attribute “stage II to emergence during specific cases” and 36 had themselves “attributed a difficult emergence to stage II.” In addition, 35 claimed they had

read about stage II in textbooks and 27 said they had read about it in journal articles, despite the fact that, according to Dr. Roth, “it is scantly mentioned in textbooks without explanation and has rarely been the subject of articles in over 50 years. “Although there is no evidence in the literature for stage II existing in the adult given modern anesthetics, stage II is being described, taught or passed along to younger anesthesiologists anecdotally,” Dr. Roth continued. Alan D. Kaye, MD, PhD, chairman of the Department of Anesthesia at the LSU Health New Orleans School of Medicine, said the findings put him in the uncomfortable position of “defending old-school nomenclature” in anesthesiology. But Dr. Kaye, a member of the editorial board of Anesthesiolog y News, said he still spends a fair bit of time on stage II with his students. Dr. Kaye agreed that stage II has largely become irrelevant in clinical practice, thanks to new, faster-acting agents and the growth of ambulatory surgery. Yet he noted that in some situations older, slower-acting agents are still used—for example, in poorly funded hospitals, in surgical cases after which postoperative admission to the hospital is planned or in cases when newer drugs are in short supply. Certain patient subpopulations, including pregnant women and the elderly, are more likely to receive excessive anesthesia. For these patients, knowledge of stage II may be relevant. “The reason stage II is still clinically relevant is that if you pull an endotracheal tube too early—or during stage II—you increase the risk for laryngospasm,” said Dr. Kaye, who was not involved in the PGA study. “It is true that stage II is almost irrelevant because of the newer agents available. However, I still think it’s important that young anesthesiologists understand the different stages of sedation, given that there are situations in which these new agents may not be used, for whatever reason.” —Brian Dunleavy

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P OLI C Y & M A NAGEMENT

Private Database Offers Insights to Anesthesia Best Practice New York—Third-party payers are demanding increasingly detailed performance and outcomes data from health care providers across all specialties. To meet this demand, researchers are ever refining the methods they use to collect this information, with an eye toward overcoming shortcomings historically associated with the process, such as the underreporting of adverse events and poor record-keeping. A team of researchers from the North American Partners in Anesthesia (NAPA), for example, believes their procedures for data collection and validation can serve as a guide for future efforts in establishing detailed clinical registries for anesthesiology management— resources they say can provide evidence-based support for best practices for rare but serious complications such as aspiration. They presented their initial findings from an analysis of adverse and unanticipated events in 256,506 cases collected as part of the NAPA clinical registry in scientific poster form during the 2012 PostGraduate Assembly (PGA) in Anesthesiology in December (poster P-9141). “Clinical outcomes registry data can be used to determine best practice and improve patient safety in a more economical manner than randomized controlled trials and be more applicable to the general surgical population,” said Frank J. Overdyk, MSEE, MD, executive director for research at NAPA, a private anesthesia management organization with more than 1,000 member providers, and lead author of the PGA poster. Since 2007, NAPA has been requesting that member providers complete a “quality improvement bubble sheet” as they manage cases, listing patient demographics, anesthesia technique used and any adverse events or complications. These forms are automatically entered into the NAPA database, and any adverse events reported within 48 hours after surgery through other quality control systems are added retroactively. For the period 2010-2011, NAPA anesthesiologists completed quality improvement sheets for more than 90% of their cases, according to Dr. Overdyk and his team. Complications such as hypothermia, prolonged stay in the postanesthesia care unit and difficult intubation occurred in 0.45%, 0.36% and 0.14% of the 256,506 NAPA cases, respectively, during that period. Reintubation rates among the NAPA cases (0.1%) were lower than those reported through the American College of Surgeons’ National Surgical Quality Improvement Program (0.9%). The incidence of aspiration among NAPA cases during the period was 0.2% and was not disproportionately higher when the airway was secured with a laryngeal mask than with an endotracheal tube, the researchers said. “Although data capture rates were high, underreporting of adverse events appears prominent in

some categories of adverse events when compared to published literature, primarily due to process deficits, such as [lack of ] paper record,” Dr. Overdyk noted. “Voluntary underreporting due to process and liability issues remain sources of noise in the data that can be mitigated by education and validation of data against other sources.”

Regarding reintubation in particular, Dr. Overdyk said, “NAPA keeps a registry of patients with difficult airways on ‘the cloud’ so that providers all over the country can be forewarned of such patients and don’t extubate them prematurely.” According to Dr. Overdyk, the NAPA team will continue to research methods to refine data collecf care tion, perhaps using smartphones or a point-ofelectronic device. In general, he says, they believe “participation in clinical outcomes registries will increase as consolidation in the industry and performance and outcome metrics become a factor in reimbursement under value-based purchasing.” Other anesthesiologists agreed. “Practices that archive their data are best positioned to take advantage of federal incentives for physician quality reporting systems and pay for performance,” said Richard P. Dutton, MD, MBA, executive director of the Anesthesia Quality Institute, in Park Ridge, Ill., who was not part of the NAPA project. “Contribution of this data ‘upward’ to a national registry allows benchmarking against national practice norms, facilitates our scientific understanding of rare adverse events, and enables comparative effectiveness research. I would like to see this group report trends over time in their data back to the practitioners themselves, and I would like to see them join the Anesthesia Quality Institute, and then report their results and trends in comparison to national benchmarks.” —Brian Dunleavy

Shorter Workweeks for Interns Do Not Promote Patient Safety—Study

policy to shorten the workweek for interns in the United States has failed to improve their quality of life and has possibly put patients at greater risk for medical errors, a new study has found. The 2011 change, recommended by the Accreditation Council for Graduate Medical Education, capped at 16 continuous hours the longest shift a first-year resident could work in the hope that doing so would ease the strain on physician trainees. But although the new rules have shortened the typical intern’s workweek from 67 to 64.3 hours, they haven’t encouraged residents to sleep more, helped them to avoid depression or increased their overall sense of well-being, the study found. Depression is linked to poor work performance; the new study found that twice as many interns meeting criteria for depression as those with better emotional health reported having committed a medical error: 35.3% versus 17.8%, respectively. And, more interns

said they were afraid of making a serious medical error after the policy change than before the shift—23.3% versus 19.9% (P=0.007). P The study, reported in the Annals of Internal Medicine, was based on email surveys of 2,323 residents (and a few graduating medical students) from a variety of medical specialties at 51 programs nationwide. The residents entered training in 2009, 2010 and 2011, after the rule change. “Given that increased sleep was a key mechanisms [sic] through which the new duty-hour restrictions were intended to improve the health of residents, the lack of such an effect in the postimplementation cohort in our study is a cause for concern,” wrote the authors, led by Srijan Sen, MD, PhD, a psychiatrist at the University of Michigan in Ann Arbor. “Designing work schedules that account for circadian phase and explicitly training residents on practices to increase sleep time and improve sleep quality may be necessary.” —AN Staff

Another Successful Year For the McMahon Group

2012

to recognize the best of an outstanding group of empployees. Now into its ﬁfth decade, the company continues to publish best-read medical newspapers and must-view meddical websites covering several clinical areas, and also creates medical education platforms for physicians, nurses andd pharmacists. All of which proves yet again that a company pow powered wered by talented people will necessarily generate su success. uccess

Here is a review of the winners of the 2012 employee awards: MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

Each year employees are asked to select two outstanding mem mbers representing these diverse departments. The first winner was DIANE LODISE, who is both the director of facilities managemeent, overseeing the facilities owned by the company, and the conveentions coordinator, planning the many details of our extensive convenntion coverage.

The second winner was HYON NG KWON, the company’s development manager for IT, for his continuuing efforts in improving the company’s digital presence.

MAX GRAPHICS PERSON OF THE YEAR

MOST IMPROVED SALESPERSON OF THE YEAR

BLAKE DENNIS was recognized for her excellence as art directtor for Anesthesiology News as well as her graphic design of a varietyy of special projects. Blake is dedicated to creating the most visually appeaaling projects possible.

BRIAN HIGGINSON, publicatioon director for Gastroenterology & Endoscopy News, was recogniized for the increase in that publication’s sales in 2012, which in part ledd to one of its most profitable years ever. His dedication to his clients’ needs and understanding of their products ensure his continued success in sales.

ASSOCIATE/SENIOR/PROJECTS EDITOR OF THE YEAR

MANAGING EDITOR OF THE YEAR

Editorial director of the special projects division, division KATHERINE REIDER was recognized for her contributions as an editor and for providingg leadership and direction to the members of the department. Her diplomacy skills and focus on process have helped ensure that projects are devveloped with the highest level of accuracy and in a timely manner. Katherinee also was recognized for her 10 years of service at McMahon.

GEORGE OCHOA was voted ed editor of the year for his efforts and dedication to McMahon Groupp through his exemplary writing and editing. His stories appear in every McMahon Group publication and on every website and provide the manaaging editors with articles that exemplify editorial excellence.

SALES ACHIEVEMENT AWARD

SALESPERSON OF THE YEAR

The publication director for General Surgery News, MICHAEL ENRIGHT, T was selected for this award in recognition of his strong commitment to his clients and his innovative thinking to create unique marketing platforms, which included the publication’s first international edition as well as the initiation of a website video arcade.

For an unprecedented seventhh year in a row, RICHARD TUORTO earned the salesperson of the year aw ward. Unlike the other awards, which are decided by peer votes, this aw ward is presented to the individual who brings in the most revenue in the calendar year. Richard manages the Anesthesiology News and Painn Medicine News teams as senior group publication director.

THE MCMAHON GROUP PERSON OF THE YEAR

PARTNERS’ AWARD

The top award each year is for the person of the year, which gooes to the employee who goes above and beyond the call throughout thee year. JEANNIE MOYER, associate director of human resources, received the honor this year. Jeannie oversees personnel and works tirelessly to provide the best possible atmosphere for employees each day. She is integral to helping McMahon Group continue to grow every year.

From time to time, the partner--owners of the company recognize the contributions of those who havee had a significant effect on the company’s success through the years. The 22012 award was given to WARD BYRNE, who served as publication director foor Anesthesiology Newss for several years, starting in the early 1990s. He w was responsible for the excellent growth of that newspaper, which today dominates the market. Ward eventually left McMahon Group to start what would be ann 11-year career working at a medical education company, after which he returneed to his true love — teaching. Today, Ward teaches special education in thee New Jersey school system.

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P OLI C Y & M A NAGEMENT

The No. 1 Key to Business Development Dear Arizona Pain Specialists, I’ve been in practice now for five years and I am in a rut. My practice has come so far, but it isn’t where I want it to be. I’d like to grow my practice and frankly deliver better health care than we do right now, but I am having trouble doing so. How can I make my practice better? Signed, Looking To Grow Dear Looking To Grow, arely do medical practices set goals and/or have a clear vision for their future. Rather, we are often reactive to changes, such as declining reimbursements or increasing regulations. It is very easy to fall into a “rut” and most practices experience this trap. As the leader of your practice, you have the ultimate say—for good or ill— in what your practice will become.

capstone for your success and everything else builds on it. Vision is who you are, why you do what you do and where you want to go. As the leader of your organization, you are responsible for the successes and failures of your organization, and most of the time they are intimately linked with the vision that you have and convey to your staff. In Jim Collins’ book, Beyond Entrepreneurship,1 he explains that vision is determined by three tenets, which build on each other: core values and beliefs, purpose and mission.

Vision Vision is thee No. 1 key for taking your practice to the next level. Vision crystalizes the who, the why and the where Core Values and Beliefs for you and your employees. Vision is Vision is initially made up of core more than just a happy slogan; it is the values and beliefs or who you are. It’s

critically important that your company’s core values and beliefs are the same as your own. They must be congruent and really must grow out of your own values. The core values and beliefs that you choose for your business should resonate with the employees you have and the customers you serve. The actions of any person in your organization should be held up to the standard of your core values. These should be personal and unique to your organization, but also should be timeless. Your values should serve as a compass for everyone in your organization when faced with daily decisions. At Arizona Pain Specialists, we have combined our core values and our beliefs into what we call LIKES: • Leadership: We understand our purpose and set the standard for others to follow. • Integrity: We have honorable character and operate at the highest level of ethical standards. • Kindness: We treat others with love, respect and an uplifting attitude.

• Excellence: We are committed to quality throughout our organization. • Service: We deliver phenomenal care and give back to our community. In our company’s culture, we strive to treat each other and our patients with our LIKES. Additionally, each staff member is judged by the way he or she reflects these values. Our core values and our beliefs play a large part in any and all decisions that we make and provide a framework on which to build. Purpose Building out of a company’s core values and beliefs is a company’s purpose. Your purpose is your why. Why does your practice exist? Your purpose must be general enough to apply to everyone in your organization, but must be specific enough to communicate with others why you do what you do. Your company’s purpose allows an opportunity for you to connect with your staff and to motivate them. Your purpose

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ORDER ONLINE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com. We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com. If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.

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Jan Ehrenwerth April 15, 2013 This book offers expert, highly visual, practical guidance on the full range of delivery systems and technology used in practice today. It equips you with the objective, informed answers you need to ensure optimal patient safety.

Anesthesiology: A Comprehensive Review for the Written Boards and Recertification

Kai Matthes; Richard Urman; Jesse Ehrenfeld May 7, 2013 This streamlined study aid contains more than 1,000 realistic multiplechoice questions tailored to the question content of recent American Board of Anesthesiology exams. To maximize reading efficiency, key messages are repeated and highlighted in the bullets. This book also covers new “emerging” topics such as patient safety, statistics and ethics.

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Carl L. Gwinnutt; Matthew Gwinnutt October 29, 2012 Perfect for medical students, junior doctors, anaesthetic nurses and allied health professionals, this book provides a thorough introduction to the modern principles and practices of clinical anaesthesia. Full-color diagrams, photographs and key fact boxes support easy understanding of the theory of anaesthetics allowing confident transfer of information into clinical practice. p

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The Anesthesia Guide

Arthur Atchabahian, Ruchir Gupta January 24, 2013 This handbook is the perfect learning tool for trainees and an outstanding reference for experienced anesthesiologists. Presented in full color, it uses numerous illustrations, diagrams, tables and algorithms to impart must-know information on how specific cases should be managed. Coverr age includes drug dosages, monitoring, complications and clinical pearls.

The Difficult Airway: A Practical Guide

Carin A. Hagberg; Carlos A. Artime; William H. Daily May 28, 2013 This book provides practical guidance on improving the success rates of airway managers of all specialties who use modern airway devices and techniques. The book addresses various clinical scenarios in a userfriendly format that mimics the approach clinicians encounter at educational workshops.

Wall & Melzack’s Textbook of Pain: Expert Consult— Online and Print: Sixth Edition

Stephen McMahon May 16, 2013 This textbook covers the latest knowledge about the genetics, neurophysiology, psychology and assessment of every type of pain syndrome. It also provides guidance on a range of pharmacologic, interventional, electrostimulative,, physiotherapeutic p y p and psychological p y g management g options. p AN0513

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should further guide your company and act as a map for your journey to success. At Arizona Pain Specialists, our purpose is: Providing Hope. Restoring Life. Every person within our organization can take pride in the fact that he or she is doing something meaningful and helping others. We each play a part in bringing hope into patients’ lives and we all work together to restore quality and function to someone’s life. Even on difficult days, our staff understands that we are working together on something that is meaningful and bigger than any one person.

Our mission lets our staff know that we

Mission From your company’s purpose comes your mission. are not here for Mission is the where. It’s a specific and targeted place where you want to be. Your values, beliefs and purpose meaningless work. should be unchanging, but your mission is typically a five- to 10-year plan that should be adjusted when you We are here for have arrived. something much At Arizona Pain Specialists, our mission is: We change lives here by delivering the world-class pain bigger than any one management care that we would want for our own mom or dad. of us—we are here to Our mission lets our staff know that we are not here for meaningless work. We are here for some- dramatically and positively thing much bigger than any one of us—we are here to dramatically and positively change lives. We can change lives. accomplish this by providing the very best care to our patients. We believe “world-class” implies safety, best pursuit of that vision.” If you know exactly where you want to go, it it’ss training, cutting-edge and our LIKES. At the end of the day, are we treating our patients like we treat our much easier to arrive at your destination. Ask yourbeloved family member? self, what do I want in a practice? Be specific. Then begin to write down your answers. They might look Putting It All Together like this: “I want to have a practice that _____.” If you were preparing for a cross-countryy drive, you • helps people with chronic pain conditions by would look at a map and realize that there are two properly diagnosing their source of pain critical things to plan for your journey. First, you • provides a holistic treatment plan to address all of need to know where you are, and second, you need a patient’s pain needs to know where you are going. Each of us would do • provides comprehensive care with a counselor, chithis for a road trip, but consider how much more ropractor, physical therapist and a nutritionist important it is for our businesses. It’s important that • allows me to perform minimally invasive intervenwe understand where we are right now in our busitional procedures that are effective at relieving pain nesses and have a clear vision of where we want to go • allows me to prescribe medications that help to with our medical practices. relieve pain Your values and beliefs act as an everyday compass; • allows me to work 4.5 days per week and have four your purpose acts as a map showing you the way; and weeks off per year for vacation your mission is your specific and final goal. Core val- • has a friendly staff Then look at each of the things you have written ues and beliefs are the ethos that helps to form your purpose, and allow you to fulfill your mission. and expand on them. A helpful role-playingg exercise Vision provides clarity and direction for the people that we use is to imagine coming to your practice as in your organization. Vision allows your organization a new patient and visualize each of the steps that you to work as a team. In his book, The Five Dysfunctions might go through in the process. Now really clarify of a Team,2 Patrick Lencioni wrote: each step of the process. For example, you might say: “Not finance. Not strategy. Not technology. It is “I have terrible back pain and my primary care docteamwork that remains the ultimate competitive tor referred me to a pain specialist that she says is the advantage, both because it is so powerful and so rare. ‘best doctor to help me with my back pain.’ The pain … A friend of mine … once told me, ‘If you could get specialist’s office calls me and a friendly staff person all the people in an organization rowing in the same introduces himself. The workers are kind and empadirection, you could dominate any industry, in any thetic as they ask about my back pain. This gives me market, against any competition, at any time.” hope, and they arrange my appointment within a Jim Collins, whose other books include Good to week. I’m emailed a reminder about my appointment. Greatt3 and Built to Last,4 said “the function of leader- When I arrive in the office, I’m greeted by a friendly ship …[is] to catalyze a clear and shared vision for the member of the pain staff who guides me through the company and to secure commitment to and vigorous paperwork. Next, I’m seen by a physician who dis-

cusses my medical history with me and listens to my current pain problems. The doctor thoroughly examines me and then explains my diagnosis and treatment plan. The doctor reassures me that we are implementing the most effective treatments for my pain.” The experiences a new patient would have in the role-playingg exercise should match the vision you have of your practice. If not, identify the ways that you are falling short. This exercise should make it clear what you need to do to take your practice to the next level. Developing your practice to meet your vision starts with your core beliefs and values. The way your practice operates should reflect your most important and unchanging beliefs and values. Your purpose—the purpose the reason your practice exists—should inspire and motivate everyone you work with. Although many of the specifics about your practice may change over time, the core values, beliefs and purpose will remain the same. This enduring purpose will drive the long-term goal you set as your mission. Having a vision for your practice—reflecting on and clarifying your core values and beliefs, purpose and mission—and conveying these ideas to your staff will allow you to continually improve your practice. In doing so, you can make your practice the kind of organization you are excited to lead and of which others are inspired to be a part. —Tory McJunkin, MD, Joe Carlton, Paul Lynch, MD, and Ted 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. They 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. Collins JC, Lazier WC. Beyond Entrepreneurship: Turning Your Business Into an Enduring Great Company. Englewood Cliffs, NJ: Prentice Hall Press; 1995. 2. Lencioni P. The Five Dysfunctions of a Team: A Leadership Fable. San Francisco, CA: Jossey-Bass; 2002. 3. Collins JC. Good to Great: Why Some Companies Make the Leap… and Others Don’t. New York, NY: HarperBusiness; 2001. 4. Collins JC, Porras JI. Built to Last: Successful Habits of Visionary Companies. New York, NY: HarperBusiness; 1994.

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Current Concepts In the Management Of the Difficult Airway

CARIN A. HAGBERG, MD Joseph C. Gabel Professor and Chair Department of Anesthesiology The University of Texas Medical School at Houston Director of Advanced Airway Management Memorial Hermann Hospital–Texas Medical Center Houston, Texas Executive Director 2009-present, Society for Airway Management Dr. Hagberg is a member of the speakers’ bureaus for Ambu A/S, Cook Medical, and LMA North America, and has received equipment support from Aircraft Medical, Ambu A/S, Clarus Medical, Cook Medical, Karl Storz Endoscopy, King Systems, and Mercury Medical.

anagement of the difficult airway remains one of the most relevant and challenging tasks for anesthesia care providers. This review focuses on several of the alternative airway management

devices/techniques and their clinical applications, with particular emphasis on the difficult or failed airway. It includes descriptions of many new airway devices, several of which have been included in the American Society of Anesthesiologists (ASA) Difficult Airway Algorithm (Figure).

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A N E S T H E S I O L O G Y N E W S • M AY 2 0 1 3

It also may become the standard for routine intubations as the equipment and usersâ&#x20AC;&#x2122; skills improve and the cost of the devices decreases, with the potential for important savings in time and decreased morbidity in patients. It is beyond the scope of this review to discuss all of the laryngoscopes that have been manufactured; thus, only some of the most recently developed blades will be described (Table 3).

INDIRECT RIGID FIBER-OPTIC LARYNGOSCOPES

Figure. The ASA Difficult Airway Algorithm. (Anesthesiology 2013;118[2]:251-270) The algorithm can be viewed at: www.asahq.org/ publicationsAndServices/practiceparam.htm

These laryngoscopes were designed to facilitate tracheal intubation in the same population that would be considered for flexible fiber-optic bronchoscopy, such as patients with limited mouth opening or neck movement. Relative to the flexible fiber-optic bronchoscopes (FOBs), they are more rugged in design, control soft tissue better, allow for better management of secretions, are more portable (with the exception of the new portable FOBs), and are not as costly. Intubation can be performed via the nasal or oral route and can be accomplished in awake or anesthetized patients (Tables 4 and 5).

SUPRAGLOTTIC VENTILATORY DEVICES

Alternative Airway Devices A common factor preventing successful tracheal intubation is the inability to visualize the vocal cords during the performance of direct laryngoscopy. Many devices and techniques are now available to circumvent the problems typically encountered with a difficult airway using conventional direct laryngoscopy.

ENDOTRACHEAL TUBE GUIDES Several endotracheal tube (ET) guides have been used to aid in intubation or extubation, including both reusable/disposable and solid/hollow introducers, stylets, and tube exchangers (Table 1).

LIGHTED STYLETS In the past decade, many lighted stylets have been developed, including light wands, which rely on transillumination of the tissues of the anterior neck to demonstrate the location of the tip of the ETâ&#x20AC;&#x201D;a blind technique, unless combined with direct laryngoscopy, and visual scopes, which use fiber-optic imagery and allow indirect visualization of the airway. They also can be used alone or in conjunction with direct laryngoscopy (Table 2).

RIGID/VIDEO LARYNGOSCOPES Video-assisted techniques have become pervasive in various surgical disciplines, as well as in anesthesiology. As more video laryngoscopes are introduced into clinical practice, and as airway managers become more skillful with the technique of video-assisted laryngoscopy, it could well become standard procedure for patients with known or suspected difficult airways.

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The Laryngeal Mask Airway (LMA, LMA North America, a Teleflex Company) is the single most important development in airway devices in the past 25 years. Since its introduction into clinical practice, it has been used in more than 200 million patients worldwide with no reported deaths. Other supraglottic ventilatory devices are available for routine or rescue situations. The most recently developed supraglottic ventilatory devices have a gastric channel or are intended to be used as a conduit for fiber-optic guided intubation (Table 6).

Special Airway Techniques AWAKE INTUBATION For managing patients in whom a difficult airway is suspected or anticipated, securing the airway before induction of general anesthesia adds to the safety of anesthesia and helps minimize the possibility of major complications, including hypoxic brain damage and death. To perform awake intubation, the patient must be adequately prepared for the procedure. Good topical anesthesia is essential to obtund airway reflexes and can be provided by various topical agents and administrative devices (Table 7). Other relatively new devices can be used to best position patients and maintain an open airway during awake intubation (Table 8). Atomizing devices currently available for delivering topical anesthesia to nasal, oral, pharyngeal, laryngeal, and tracheal tissues include the DeVilbiss Model 15 Medical Atomizer (DeVilbiss Healthcare), the Enk Fiberoptic Atomizer Set (Cook Medical), and the LMA MADgic Laryngo-Tracheal Atomizer (LMA North America, a Teleflex Company). Although any technique of tracheal intubation can be performed under topical anesthesia, flexible fiber-optic intubation is most commonly used.

FLEXIBLE FIBER-OPTIC INTUBATION Flexible fiber-optic intubation is a very reliable approach to difficult airway management and assessment. It has a more universal application than any other technique. It can be used orally or nasally for both upper and lower airway problems and when access to the airway is limited, as well as in patients of any age and in any position. Technological advances—including improved optics, battery-powered light sources, better aspiration capabilities, increased angulation capabilities, and improved reprocessing procedures have been developed. A completely disposable system, the aScope2 (Ambu) also is available. Rescue techniques, such as direct laryngoscopy and placing a retrograde guidewire through the suction channel, may be used if the glottic opening cannot be located with the scope, or if blood or secretions are present.17 Insufflation of oxygen or jet ventilation through the suction channel may provide oxygen throughout the procedure, and allow additional time when difficulty arises in passing the ET into the trachea.

RETROGRADE INTUBATION Retrograde intubation (Table 7) is an excellent technique for securing a difficult airway either alone or in conjunction with other airway techniques. Every anesthesia care provider should be skilled in employing this simple, straightforward technique. It is especially useful in patients with limited neck mobility (that is associated with cervical spine pathology, or in those who have suffered airway trauma). Cook Medical has 2 retrograde intubation sets: a 6.0 Fr for placing tubes of 2.5 mm or greater ID, and a 14.0 Fr for placing tubes of 5.0 mm or greater ID.

TRANSTRACHEAL JET VENTILATION Transtracheal jet ventilation (TTJV) is a well-accepted method for securing ventilation in rigid and interventional bronchoscopy, and there are several commercial manual jet ventilation devices available (Table 7). The Enk Oxygen Flow Modulator (Cook Medical) is a device recommended for use when jet ventilation is appropriate but a jet ventilator is not available. The Wadhwa Emergency Airway Device (Cook Medical), which also can be used for TTJV, is several devices in one (Table 7). It has an emergency nasopharyngeal airway catheter; a largediameter transtracheal needle for a cricothyrotomy procedure with the option for TTJV; and the main body of the device acts as a blow tube or 15-mm adapter.

CRICOTHYROTOMY Cricothyrotomy (Table 9), a lifesaving procedure, is the final option for “cannot-intubate, cannot-ventilate”

patients according to all airway algorithms, whether they concern prehospital, emergency department, intensive care unit, or operating room patients. In adults, needle cricothyrotomy should be performed with catheters at least 4 cm and up to 14 cm in length. A 6 Fr reinforced fluorinated ethylene propylene Emergency Transtracheal Airway Catheter (Cook Medical) has been designed as a kink-resistant catheter for this purpose. Percutaneous cricothyrotomy involves using the Seldinger technique to gain access to the cricothyroid membrane. Subsequent dilation of the tract permits passage of the emergency airway catheter. Surgical cricothyrotomy is performed by making incisions through the cricothyroid membrane using a scalpel, followed by the insertion of an ET. This is the most rapid technique and should be used when equipment for the less invasive techniques is unavailable and speed is particularly important.

TRACHEOSTOMY Tracheostomy (Table 10) establishes transcutaneous access to the trachea below the level of the cricoid cartilage. Emergency tracheostomy may be necessary when acute airway loss occurs in children under 10 years of age or children whose cricothyroid space is considered too small for cannulation, as well as in individuals whose laryngeal anatomy has been distorted by the presence of pathologic lesions or infection. Percutaneous dilatational tracheostomy is the most commonly performed tracheostomy technique, yet it is still considered invasive and can cause trauma to the tracheal wall. Translaryngeal tracheostomy, a newer tracheostomy technique, is considered to be safe and cost-effective, and it can be performed at the bedside. It may be beneficial in patients who are coagulopathic. Surgical tracheostomy is more invasive, and should be performed on an elective basis and in a sterile environment.

Conclusion Most airway problems can be solved with relatively simple devices and techniques, but clinical judgment born of experience is crucial to their application. As with any intubation technique, practice and routine use will improve performance and may reduce the likelihood of complications. Each airway device has unique properties that may be advantageous in certain situations, yet limiting in others. Specific airway management techniques are greatly influenced by individual disease and anatomy, and successful management may require combinations of devices and techniques.

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Table 1. Endotracheal Tube Guides Name (Manufacturer)

Description

Length, cm

Aintree Intubation Catheter (Cook Medical)

Polyethylene 19 Fr AEC allows passage of an FOB through its lumen. Has 2 distal side holes and is packaged with Rapi-Fit adapters. Color: light blue.

Arndt Airway Exchange Catheter Set (Cook Medical)

Polyethylene 8 and 14 Fr AEC with a tapered end, multiple side ports, packaged with a stiff wire guide, bronchoscope port, and Rapi-Fit adapters. Color: yellow.

50, 65, 78

Cook Airway Exchange Catheter EF (Cook Medical)

Polyethylene 11 and 14 Fr EF AEC that facilitates exchange of DLT of 4.0 mm or larger ID. Also comes in a soft-tip version. Colors: EF, green; soft-tip version, green with purple tip.

100

Frova Intubating Introducer (Cook Medical)

Polyethylene 8 and 14 Fr AEC with angled distal tip with 2 side ports. Has hollow lumen and is packaged with a stiffening cannula and removable Rapi-Fit adapters. 14 Fr also packaged in box of 10. Colors: 8 Fr, yellow; 14 Fr, blue.

35, 65

GlideRite Rigid Stylet (Verathon Medical)

Reusable, sterilizable, semirigid stylet that conforms to GlideScope unique blade angulation; provides improved maneuverability in ET placement.

32.34 cm (12.73 in). Accommodates ETs 6.0-10.0 mm ID.

Introes Pocket Bougie (BOMImed)

Single use, 14 Fr (4.7 mm) malleable ET introducer made from special blend of Teflon. Packaged in box of 10.

60. Accommodates ETs ≥5.0 mm ID.

Muallem ET Tube Stylet Single-use 8, 12, 14 Fr stylet; malleable, but with soft and (VBM Medizintechnik GmbH) atraumatic coudé tip. Color: green.

40, 65

OptiShape Stylet (Truphatek International Ltd)

Reusable, sterilizable, semirigid stylet with optimal shape memory for indirect intubation procedures.

4 sizes. Accommodates ETs 2.5-3.5, 4.0-5.5, 5.0-6.5, and 7.0-9.0 mm ID.

Portex Venn Tracheal Tube Introducer (Smiths Medical)

15 Fr ET introducer made from a woven polyester base, with a coudé tip (angled 35 degrees at its distal end). Also known as the gum elastic bougie. Color: golden brown.

RadLyn Stylet R-100 (RadLyn LLC)

Single-use, semirigid dilating stylet employing malleable guide tip and soft, dilating balloon.

Single size only. Accommodates ETs 7.0-10.0 mm ID.

Single-Use Bougie (Smiths Medical)

15 Fr, PVC ET introducer with coudé tip. Has a hollow lumen that discourages reuse and is provided sterile. Color: ivory.

Truflex Flexible Stylet Reusable, stainless steel stylet. Has flexible tip with upward (Truphatek International Ltd) lift action of 30-60 degrees, depending on size of ET.

Suitable for use with ET tubes 6.5-8.5 mm ID.

VBM Introducer Single-use 15 Fr introducer with coudé tip and hollow for (VBM Medizintechnik GmbH) oxygenation. Color: orange.

VBM Tube Exchanger Single-use 11, 14, and 19 Fr tube exchanger that is hollow (VBM Medizintechnik GmbH) to allow oxygenation. Color: blue.

Abbreviation key for all tables is on page 13.

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Clinical Applications

Special Features

Exchange of SGAs for ETs ≥7.0 mm using an FOB. Its hollow lumen allows insertion of an FOB directly through the catheter so that the airway can be indirectly visualized.

Large lumen (4.7 mm) allows passage of FOB. Rapi-Fit adapters allow both jet ventilation and ventilation with 15-mm adapter (anesthesia circuit or Ambu bag). Single use.

Exchange of LMAs and ETs using an FOB.

Tapered end and multiple side ports. Rapi-Fit adapters allow both jet ventilation and ventilation with 15-mm adapter (anesthesia circuit or Ambu bag). Single use.

Exchange of DLTs.

EF with 2 distal side holes. The soft-tip version offers a more flexible tip to help minimize tracheal trauma. Rapi-Fit adapters as above, but should be used primarily for jet ventilation because of length. Single use.

Facilitates endotracheal intubation and allows simple ET exchange. Can also be used by placing it first in the ET, with its tip protruding, or placing it directly into the glottis and then placing the ET over it.

Can be used in pediatric population for ETs as small as 3.0 mm. Hollow lumen allows oxygenation/ventilation in all sizes. Single use.

Designed to work with GlideScope AVL, GVL, Cobalt, and Reusable, durable stainless steel; easy to clean and Ranger video laryngoscopes to facilitate intubations in sterilize in an autoclave. OR, ED, and emergency settings. Designed to facilitate endotracheal Intubation for both direct and video laryngoscopy. Unique curvature designed to follow natural path of the airway. Flexibility allows for manipulation of distal tip for anterior airways. Customizable coudé tip angles.

Self-lubricated bougie, Tactiglide technology for tactile sensation, optimal curve with shape memory, balanced rigidity with soft tissue protection, non-removable depth markings, packaged sterile.

Difficult intubation.

Malleable stylet with soft coudé tip and graduation marks for insertion depth.

Facilitates smooth passage of ET in both routine and difficult intubations. Especially useful in combination with the variety of video laryngoscopes that employ >42-degree angles. Designed with the ideal curve to closely follow the blade shape and ensure successful passage of ET through vocal cords.

Easily adjustable to a variety of ET sizes. Suitable for use in combination with a variety of video laryngoscopes that employ >42-degree angle of vision.

Proven useful in patients with an anterior larynx (grades 2b, 3, and 4) and those with limited mouth opening. Can be used by slightly protruding through the ET, or placing it directly into the glottis and then placing an ET over it.

Nondisposable and reusable. Size 5 Fr is single use. Has memory properties. Coudé tip effectively detects “tracheal clicks” to confirm correct placement. Part of a range of introducers, stylets, and guides for adults and pediatrics. Can be reused after cold-water disinfection.

Combines the functionality of a coudé tip bougie with a traditional wire stylet into a single, easy-to-use device. Facilitates smooth passage of ET in routine intubations; when the laryngeal inlet is distorted, edematous, or narrowed; when vocal cords are reactive (ie, nonparalyzed); or when Cormack-Lehane grade III/IV view is encountered.

Tapered, dilating balloon facilitates mechanical dilation of the laryngeal anatomy for less traumatic passage of the ET.

Single-use product reduces the risk for cross-contamination. Otherwise, same as Portex Venn Tracheal Tube Introducer.

Similar to Portex Venn Tracheal Tube Introducer, but hollow lumen allows oxygenation/ventilation. Single use.

Eases clinical coordination difficulties associated with use of video laryngoscopes by providing greater control of ET tip direction.

Adjustable stopper allows use with e-tubes of differing lengths.

Difficult intubation with oxygenation possibility.

Supplied with unique removable connector to allow oxygenation with 15-mm connector or jet. Graduation marks for insertion depth.

Exchange of tracheal tubes.

Similar to Muallem ET Tube Introducer.

A N E S T H E S I O L O G Y N E W S • M AY 2 0 1 3

Table 2. Lighted Stylets Name (Manufacturer)

Description

Size

Aaron Surch-Lite (Bovie Medical Industries, Inc.)

10-in sterile, single-use, flexible stylet.

Adult

AincA Lighted Stylet (Anesthesia Associates, Inc.)

Easily malleable, lighted stylet with adjustable ET holder. Shapes and guides ET while forwardly illuminating the passage. Completely reusable device consisting of removable handle with xenon bulb.

Adult and children (ETs ≥5 mm). Infant (ETs ≥3 mm).

air-Vu Plus Fiber-optic Stylet High-resolution, stainless steel, rigid stylet. Incorporates an (distributed by Mercury adjustable tube stop and optional oxygen port for oxygen Medical) insufflation.

Adult (ETs ≥5.5 mm).

Bonfils Retromolar Intubation Endoscope (KARL STORZ Endoscopy)

High-resolution rigid fiber-optic stylet with a fixed 40-degree curved shape at the distal end. Available with a standard eyepiece or with a direct coupling interface (DCI) to endoscopic camera system. Can be used within the C-MAC system while using the portable monitor of the C-MAC video laryngoscope with C-CAM camera head.

3.5 and 5.0 mm OD. ET must be ≥0.5 mm larger to fit.

Brambrink Intubation Endoscope (KARL STORZ Endoscopy)

High-resolution semirigid fiber-optic stylet with a 40-degree curved shape at the distal end, 40× magnification, a fixed eyepiece, a movable ET holder, and an insufflation port.

2.0 mm OD. ET must be ≥0.5 mm larger to fit.

Clarus Video System 30000-V (Clarus Medical)

Malleable (shapeable) stylet with a digital camera; USB for recharging lithium ion battery and connecting to wireless notebook or monitor; red LED for transillumination. Optional detachable flexible scope and laryngoscope blades available.

5 mm OD. ETs ≥5.5 mm.

Levitan GLS (Clarus Medical)

High-resolution optics, malleable (shapeable) stainless steel Adult (ETs ≥5.5 mm ID). stylet that protects the illumination optic fibers. Comes in a preformed hockey-stick shape that can be changed, if necessary. Built-in tube stop to hold ET in place with integral oxygen port for oxygen insufflation during intubation.

PocketScope (Clarus Medical)

Conveniently sized, easy to clean, and cost-effective (reusable) flexible stylet that has a patented, deflected, nondirectable tip.

Adult (ETs ≥4.0 mm ID).

Rüsch Trachlight Stylet & Tracheal Light Wand (Teleflex Medical)

Consists of 3 parts: a reusable handle, a flexible wand, and a stiff, retractable stylet.

Available in 3 sizes: adult, child, and infant. Accommodates ETs 3.0-10.0 mm ID.

SensaScope (Acutronic Medical Systems AG)

Hybrid S-shaped, semirigid fiber-optic intubation video stylet. Has a 3 cm steerable tip with video chip that can be flexed in sagittal plane 75 degrees in both directions with lever at proximal end of device. Has no working channel.

6.0 mm OD. ET must be >0.5 mm larger to fit.

Shikani Optical Stylet (SOS; Clarus Medical)

High-resolution, stainless steel, malleable (shapeable) fiberoptic stylet that comes in a preformed hockey-stick shape. Has an adjustable tube stop and integral oxygen port for oxygen insufflation.

Adult (ETs ≥5.5 mm ID). Pediatric (ETs 2.5-5.0 mm ID).

Tube-Stat Lighted Intubation Similar to AincA lighted stylet. Stylet (Medtronic)

Nasotracheal: 33 cm shaft; Orotracheal: 25 cm shaft

Vital Signs Light Wand Illuminating Stylet (GE Healthcare)

Adult

Similar to AincA lighted stylet.

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Clinical Applications

Special Features

Although usable for routine blind intubations or additional Can be used alone or with other techniques. System is illumination during laryngoscopy, it is especially usecompletely disposable. Intended for single use. ful when the FOB is unavailable (eg, outside locations or Individually packaged in boxes of 3. ambulances), or when bronchoscopy is difficult to perform (eg, obscured airway or limited head motion allowed). Same as Aaron Surch-Lite.

Can be used alone or with other techniques. Handlemounted xenon light source is always on and keeps stylet tip cold. Uses 2 AA batteries. System is completely reusable and sterilizable.

Allows for visualization during intubation through an air-Q laryngeal mask.

A portable, durable rigid stylet that allows for a fiber-optic view during intubation through the air-Q. Light source options include GreenLine laryngoscope handle or fiberoptic light source (4 AA batteries).

Able to elevate a large, floppy epiglottis and navigate through the oropharynx of patients with excessive pharyngeal soft tissue, midline obstruction, limited mouth opening, or fragile veneers on incisors.

Fixed-shape shaft with an adjustable eyepiece that allows ergonomic movement during intubation, in addition to an adapter for fixation of ETs and oxygen insufflation. Portable, rugged, and better maneuverability than the flexible FOB. Used with a battery-powered or portable light source.

Similar to Bonfils Retromolar Intubation Fiberscope.

Available for DCI video cameras.

ET intubation, confirmation, extubation (with video); LMA placement, positioning, and intubation with certain LMAs. Provides access with limited mouth opening; malleable stylet provides shaping to reduce cervical movement.

Red LED provides better illumination than the white LED, and better transillumination when used like a light wand in cases when use of the scope is contraindicated because of blood or vomit.

Originally designed as an adjunct to direct laryngoscopy. Many use it as a stand-alone device similar to the Shikani for intubation, cric/trach tubes, LMAs, and intubation through LMAs or just positioning or checking placement of the same.

GreenLine laryngoscope handle or a Turbo LED can be used for light sources. Very similar to the SOS, but requires the user to cut the ET because it does not have a movable tube stop.

Allows for visualization during intubation through ILMA or quick confirmation of SGA, DLTs, or ET placement/ positioning patency. May also be used for extubation.

This device has been modified with a patented deflected tip that allows it to be used for viewing while performing nasal intubation.

Although it can be used for routine intubations, it is Blind technique that can be used alone or with other especially useful in situations in which the FOB is unavail- techniques. able (eg, in ambulances or outside locations), or in which bronchoscopy is difficult to perform (eg, when an airway is obscured by blood or secretions or when a patientâ&#x20AC;&#x2122;s head cannot be flexed or extended). Similar to Brambrink Intubation Endoscope.

Offers an improved view of glottis, simultaneous direct and endoscopic views, full visual control over passage of ET, and confirmation of final position. No need for extreme head extension or forced traction of laryngoscope. Can be rapidly assembled for immediate use.

Has the simple form of a standard stylet, plus the advanSimilar to flexible FOB. Can be used alone or as an adjunct to laryngoscopy and is especially useful for those tage of a fiber-optic view and maneuverability of its tip. Portable, rugged, and able to lift tissue. Light source unable to maintain skills with a bronchoscope.4 options are light cable, Turbo LED or GreenLine laryngoscope handle with adapter. Ideal for difficult intubations, teaching.

Minimizes neck flexion and head hyperextension in trauma cases.

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Table 3. Video Laryngoscopes Name (Manufacturer)

Description

Size

Airtraq Avant distributed by Airtraq LLC (Prodol Meditec SA, Spain)

Disposable video laryngoscope that provides a magnified angular view of the glottis without alignment of oral, pharyngeal, and tracheal axes. Includes a guiding channel to both hold and direct ET toward the vocal cords. Reusable optic piece (up to 50 intubations). Disposable blade and eyecup.

Regular adult for ET 7.0-8.5 mm ID, small adult for ET 6.0-7.5 mm ID.

Airtraq SP distributed by Airtraq LLC (Prodol Meditec SA, Spain)

Optional snap-on camera can be attached for viewing on external wireless monitor, which has display, record, and playback functions compatible with all Airtraq models.

7 color-coded sizes available: regular adult for ET 7.08.5 mm ID; small adult for ET 6.0-7.5 mm ID; pediatric for ET 4.0-5.5 mm ID; infant for ET 2.5-3.5 mm ID; nasotracheal (adult and infant); and double-lumen endobronchial tubes.

Berci-Kaplan DCI Video Laryngoscope System (KARL STORZ Endoscopy)

Video laryngoscope system with interchangeable laryngoscope blades. Platform system enables a DCI camera head to snap onto any standard eyepiece fiberscopes (flexible or semirigid). Required components include a camera control unit, xenon light source, and monitor. Telepack portable combination video/light source/monitor unit is also available for use with this system.

MAC 2-4, Miller 0, 1, 4, Dรถrges universal blade and d-Blade for difficult very anterior airways.

C-MAC Video Laryngoscope (KARL STORZ Endoscopy)

Instant on, battery-powered video laryngoscope with standard shaped interchangeable Macintosh and Miller blades for obese adults through neonates as well as a difficult airway blade ( d-Blade) for very anterior airways. Blades house high-resolution CMOS distal chip and LED technology. Real-time viewing on 7-inch LCD monitor. Dรถrges d-Blade has angle of view that is approximately 80 degrees acute curvature design.

MAC 2-4, Miller 0 and 1, MAC 3 and 4 with channel for suction, d-Blade.

C-MAC Pocket Monitor (KARL STORZ Endoscopy)

Highly portable rescue device, 2.4-in monitor fits directly on all C-MAC blades. LCD 4.3 ratio high-resolution screen works in direct sunlight; rechargeable battery lasts one hour; ergonomic screen can be moved in several directions and folded away for transportation; fully immersible.

Same as C-MAC.

CoPilot VL (Magaw Medical)

Next-generation video laryngoscope with an acutely angled blade and C-shaped channel for a bougie; a 14 Fr suction catheter, LTA kit, or FOB also fit. The lithium polymer internal battery provides over 2 hours of continuous use. No buttons or settings.

Adult sizes 3 and 4. Pediatric sizes available.

GlideScope AVL (Advanced Video Laryngoscope; Verathon Medical)

Portable advanced video laryngoscope features a digi6 disposable blades, sizes tal color monitor and digital camera for DVD clarity. Also 0-4. Reusable blades in 4 includes integrated real-time recording and onboard sizes: GVL 2-5. video tutorial. Reveal anti-fog feature to resist lens fogging. Reusable and single-use options available.

Direct Intubation Trainer combines the characteristics of a standard Macintosh blade with AVL video technology. Digital video camera near end of blade and digital AVL color monitor. Anti-fogging mechanism resists lens clouding/secretions.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

Comparable to a 3.5 Macintosh blade.

Clinical Applications

Special Features

Intended to facilitate intubation in both routine and difficult airway situations. Useful in all cases where ET tube intubation is desired. Also appropriate for emergency settings, cervical spine immobilization, fiberscope guidance, tube exchange, and foreign body removal.

Optics fully isolated from patient, preventing cross-contamination. Advanced airway device with built-in anti-fog system, and low-temperature light source. Can be used with standard ETs. Integral tracking channel allows ET to be directed without a stylet or bougie. May be used in MRI suite as MRI compatible.

Same as Airtraq Avant.

Same as Airtraq Avant but totally disposable and self-contained. 3-year shelf-life.

Useful for anterior airways, obese patients, and patients with limited mouth opening or neck extension. Variety of blade sizes and designs accommodates patients ranging from morbidly obese to neonate (500 g). Additionally useful for teaching purposes, verification of ET position, aiding application of external laryngeal manipulation, or passage of an intubating introducer. May also be used for nasal intubation and ET exchange.

The wide-angle camera allows improved visualization and video documentation of laryngoscopy and intubation. Extreme positioning of the head is unnecessary. Blades provide 80-degree field of view.

Same as DCI. Highly portable system for use in all hospital settings.

Unique platform design is compatible with multiple intubation devices, including video laryngoscopes, the F.I.V.E. distal chip flexible video scopes, and standard eyepiece scopes (fiber-optic and semirigid) via C-CAM camera head. Built-in still and video image capture on memory card, with real-time playback on monitor. Angled distal lens provides 80-degree field of view. Inherent anti-fog design. Unit can be pole-mounted or inserted into waterproof field bag. No special ETs or stylets needed. Can be used while battery is charging.

Ideal for ICU, crash carts, ED and all prehospital environments including EMS, ambulatory services, air transport, and military. Has familiar blade design and 80-degree field of view.

Lightweight, handheld, and battery-operated device well suited for areas outside the OR. Waterproof.

Same as DCI.

Patent-pending Bougie Port was designed to enhance glottic entry. A 14 Fr suction catheter, FOB, reusable rigid stylets, or regular malleable stylets may also be used via this port. A built-in heating mechanism helps prevent fogging.

DVD-quality airway view enables swift intubation in a wide range of adult and pediatric patients, including preterm/small child and morbidly obese, bloody or anterior airways, and patients with limited neck mobility. Optimized for demanding applications in the OR, ED, ICU, and NICU. Can be used for teaching.

Real-time recording, onboard video tutorial, anti-fog feature to resist lens fogging, advanced resolution output to an external monitor, intuitive user controls and status icons, lightweight and easily transportable, impact-resistant, durable polycarbonate-coated video screen. Disposable blades allow quick turnaround and help limit the possibility of cross-contamination.

Designed to facilitate instruction of classic DL. Digital video camera near the end of the blade and digital AVL monitor allow instructors to watch and guide a DL intubation. Ideal for performing video-guided DL in a clinical setting.

Compatible with AVL and GVL video laryngoscopes. Available in reusable configuration.

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Table 3. Video Laryngoscopes (continued) (continued) Name (Manufacturer)

Description

Size

GlideScope Ranger and Ranger Single Use Video Laryngoscopes (Verathon Medical)

Portable video laryngoscope designed for EMS and military paramedics. Compact and rugged. Operational in seconds.

Reusable Ranger offers 2 blade sizes, 3 and 4 (patient sizes, 22 lb to morbidly obese). Ranger Single Use is offered with 6 disposable Stats sizes 0-4.

GlideScope Video Laryngoscope (GVL) (Verathon Medical)

Video laryngoscope that includes high-resolution camera, anti-fogging mechanism to resist lens clouding/ secretions, nonglare color monitor.

6 disposable blades, sizes 0-4. Reusable blades: GVL 2-5.

King Vision Video Laryngoscope (King Systems)

Durable, fully portable digital video laryngoscope with a high-quality reusable display and disposable blades. Display aligned with blade, ergonomic handle integrated into blade, the disposable blades incorporate the camera and light source, anti-fog coating on distal lens. Channel is soft, allowing for easy ET detachment.

One size, 2 versions, correlating to size 3 laryngoscope. Channeled blade allows use of 6.0 to 8.0 mm ET and min mouth opening of 18 mm. Standard blade requires min mouth opening of 13 mm.

McGrath MAC (Aircraft Medical Ltd; distributed by Covidien)

Portable video laryngoscope designed for everyday use in the OR, ICU, and ED. Uses disposable Macintosh shaped blades. Durable (drop tested up to 2 m). Screen displays minute-by-minute battery life countdown.

Blade sizes 2, 3, and 4.

McGrath Series 5 Video Laryngoscope (Aircraft Medical Ltd; distributed by LMA North America, a Teleflex Company)

Portable video laryngoscope with adjustable-length single-use disposable blade that can be disarticulated from the handle to further assist with difficult airways. The flat screen monitor is located on the handle to remain in a more natural line of sight with the patient.

Adjusts to fit many adult and pediatric sizes.

Pentax Airway Scope (Pentax Medical; distributed by Ambu Inc.)

Wireless video laryngoscope with disposable transparent blade (Pblade) that has a suction port. Has a 12-cm cable with CCD camera and 2.4-in LCD color monitor.

One size only.

Truview PCD-R Optical Laryngoscope blades with recording capabilities (Truphatek International Ltd)

Fully portable, lightweight and compact system with interchangeable low-profile stainless steel 47-degree angled narrow tip laryngoscope blades with built-in oxygen delivery system which can be used independently or magnetically linked to the camera and 5-in LCD color monitor with picture and video recording capabilities.

Blade sizes 0, 1, 2, 3, and 4.

Venner AP Advance Video Laryngoscope (Venner Capital S.A.)

Fully portable video laryngoscope with 3.5-in monitor that attaches to a reusable handle. Self-contained LED light source. Built-in anti-fogging mechanism.

MAC 3 and 4, and Difficult Airway Blade.

VividTrac (Mercury Medical)

Video intubation device that works on many computer systems equipped with USB II port as a standard USB camera, using available video camera applications on Windows, Mac, and Linux systems. Alternatively, automated video display software (VividVision) can be downloaded.

ET 6.0-8.5 mm

The McGrath Series 5 HLDi is the new â&#x20AC;&#x153;High Level Disinfection Immersibleâ&#x20AC;? system that is entirely waterproof.

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Clinical Applications

Special Features

Ideal for EMS (ground and air), military, ED, ICU, and crash cart settings. Offers same benefits as AVL, GVL.

Ranger models are compact, rugged, portable, and built to military and EMS specifications. Powered by rechargeable lithium polymer battery; 1.5 lb. Awarded US Army Airworthiness and US Air Force Safe-to-Fly certifications. Reusable and disposable.

Useful for a wide range of adult and pediatric patients, including preterm/neonatal and morbidly obese, bloody or anterior airways, and patients with limited neck mobility. Optimized for applications in the OR, ED, ICU, and NICU. Also can be used for teaching.

Offers improved visualization and allows video documentation of laryngoscopy and intubation.

Facilitates both routine and difficult intubations.

Can be used alone or with other techniques. Powered by 3 AAA batteries. OLED screen allows wide-angle viewing in various lighting conditions. Video out available for connection to external display or video capture device.

Its dual capability combines the benefits of a video-supported anterior view as well as a direct visualization to support a wide range of airways from routine to more difficult cases.

Does not require additional training. Supports direct and indirect visualization due to video support. Blade is very slimline for improved agility. Blade shape requires less tube curvature than other video laryngoscopes for easier insertion and a stylet is not always required. Highly portable and lightweight. Does not require an electrical outlet and thus is ideal for settings outside the OR. Uses disposable blades for quick turnaround between uses and for limiting crosscontamination. The monitor is located on the handle to remain in a more natural line. Waterproof.

Useful in patients with limited mouth opening or head and neck movement, anterior airways; obese patients; patients in whom an increased hemodynamic response is a concern; and for teaching.

Highly portable and lightweight. Uses disposable blades for quick turnaround between uses and for limiting crosscontamination. An adjustable blade allows use of different blade lengths on the spot. Low-profile blade and disarticulating handle can accommodate patients with very limited mouth opening and severely limited movement of the head and neck. The monitor is located on the handle to remain in a more natural line of sight with the patient.

Similar to McGrath Video Laryngoscope. Useful for patients with limited neck mobility. Does not require alignment of the oral, pharyngeal, and laryngeal axis. Ideal for prehospital use. Monitor permits viewing from various positions to facilitate all methods of intubation. Additionally useful for teaching.

Green target symbol on monitor display indicates direction of the tracheal tube tip. The Pblade comes with 2 channels: one allows safe placement and insertion of ET, and the other has a suction port through which a suction catheter can be passed. ET is attached to right side of the blade. The device, powered by 2 AA alkaline batteries, is portable with a 1-hour run time and 5-minute low-battery warning.

Difficult intubation cases where mouth opening and neck extension are limited and stable O2 saturation levels are critical.

Blades can be linked to STORZ HD or other endoscopic systems.