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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • M a y 2 0 1 4 • Volume 40 Number 5
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Hypothermia During Surgery Affects Even Warmed Patients San Francisco—Despite forced-air warming, hypothermia is common and often prolonged in patients undergoing noncardiac surgery, researchers have found. The new study showed that patients who experienced temperatures below 35 C had significantly longer hospital stays and greater transfusion requirements. Perioperative hypothermia is assoPerioper ciated w with morbid myocardial outcomees, wound infection and coaggulopathy—links that have proompted widespread guidelinees for maintaining normothermia in surgery patients.
anesthesiologynews
POISE-2 Disappoints On Prevention of Post-Op Heart Attacks
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he perioperative administration of either aspirin or clonidine does not reduce the risk for heart attacks in patients undergoing noncardiac surgery, researchers have found. The twin findings, part of a single trial reported recently in The New England Journal of Medicine, mean clinicians still do not have a safe and effective medica-tion with which to prevent myocardial infarction (MI) in surgery patients.
see cold page 20
see POISE-2 page 22
Reports Show Recent Uptick In Hospital Violence Shootings still very rare; increase possibly due to better reporting; targets of violent acts usually not random Washington—In December, an angry former patient walked into a medical office in Reno, Nev., and fatally shot urologist Charles Garo Gholdoian and injured two others before turning the gun on himself. In a note left at his home, the gunman made it clear he was targeting physicians, an act of revenge for what he deemed were errors made during a vasectomy years before, according to media reports.
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The tragedy was a real-life event of a scenario that many health care workers fear, unfathomable as it may be in a workplace dedicated to saving lives. “Hospitals used to be considered a sanctuary, where you saw violence but not a lot of violence. You [went] there to get help. But as times change, society changes. We are seeing more violence in the world for reasons see violence page 24
PAIN MEDICINE
Inside Stanford University’s award-winning pain treatment center.
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CLINICAL ANESTHESIOLOGY
Nerve blocks put the chill on hot flashes.
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Is your hospital ready to get smart?
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CDC report links inappropriate antibiotic scripts to patient deaths.
EDUCATIONAL REVIEW
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4 I AnesthesiologyNews.com
MAY 2014
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Heard Here First: It should be clear to everyone in the audience that rationing
May 2014
Health care needs are boundless. You cannot
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1. Anesthetic Choice for TKA Cases Tied to Board Certification 2. How (Not) To Spend $1 Million 3. Block Nurses Improve RA Care 4. Ultrasound: The New Standard of Care for Percutaneous Dilatational Tracheostomy? 5. Following a Surgical Checklist Improves Patient Care
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MAY 2014
CORRESPONDENCE
‘Survival of the Fittest’ for Outsourcing Facilities To the Editor: he Drug Quality and Security Act (DQSA), signed into law on Nov. 27, 2013, has been a game-changerr for the pharmacy compounding industry (see Anesthesiology News, April 2014, page 8). My company, PharMEDium, had been an advocate for the new law and was the first entity to voluntarily register with the FDA in the newly created “outsourcing facility” category. As of Feb. 28, however, of the estimated 3,000 compounding pharmacies that make sterile injectable drugs, only 28, including all four of our locations, have registered, which raises a question about how many outsourcing facilities will ultimately register. The DQSA requirements for outsourcing facilities are challenging, but feasible, and we are pleased the law helps establish and strengthen FDA oversight by eliminating a patchwork of ambiguous federal jurisdiction and inconsistent state regulatory approaches, especially those related to licensing. The law itself and the subsequent FDA draft guidance for outsourcing facilities cover several aspects of the new category: registration, interim product reporting and labeling additions, all of which we are following. We also submitted letters to the agency during the draft guidance’s public comment period requesting several clarifications to help us better understand and follow the law’s requirements. As the FDA deliberates on the public comments from our company and other stakeholders, we firmly believe that in the long run the law will create greater clarity and certainty into the oversight of compounding facilities. This will result in a significant advance in the integrity of customized, compounded sterile preparations administered to millions of patients and will align all large-scale anticipatory compounding outsourcing facilities with the proper standards and requirements. The impetus for the DQSA was the 2012 fungal meningitis outbreak attributed to the New England Compounding Center (NECC) that resulted in more than 750 cases of confirmed or probable fungal meningitis. A federal investigation of outsourcing facilities followed, with the FDA and Congress determining that, in part, poor regulatory coordination and gaps in oversight may have contributed to the outbreak. The DQSA attempts to correct this situation by establishing a stronger federal oversight and enforcement role under the FDA. Most significantly for our company, the law created the outsourcing facility category under a new section 503B of the Food, Drug & Cosmetic (FD&C) Act to regulate our category. To be designated as an outsourcing facility, the entity, among other requirements, must register with the FDA. If an entity chooses not to register with the FDA, then it is technically not an outsourcing facility, and its operation will be regulated under a different section of the FD&C Act, 503A, which requires that it adhere to the requirements of a traditional stateregulated pharmacy. During a media briefing shortly after the DQSA’s passage, FDA Commissioner Margaret Hamburg, MD, urged hospitals to purchase from only FDAregistered outsourcing facilities, calling it “a critical
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step they can take to better ensure the health and safety of their patients.” Numerous questions remain, however, even after the law was passed, about how facilities that do not register, yet currently perform outsourcing, will be regulated. Hospitals that have partnered in the past for certain types of compounding (e.g., anticipatory non–patientspecific), may become increasingly concerned that their compounder has not chosen the 503B pathway. Although DQSA has certainly affected PharMEDium, many 503B outsourcing facility requirements are not new to our company. For example, PharMEDium has been registered and inspected by the FDA since its inception more than a decade ago. Moreover, as the law requires, we always have followed current Good Manufacturing Practices for pharmacy compounding.
“demand that their sterile compounded drugs be sourced exclusively from outsourcing facilities regulated by the FDA.” Mr. Outterson, who was a member of the Massachusetts Special Commission on the Oversight of Compounding Pharmacies that convened after the NECC tragedy, also wrote that the decision to purchase from registered outsourcing facilities could be “included in accreditation standards and reimbursement contracts. Such a market-basedd response would force compounders to accede to their major customers’ demands and register with the FDA.” Hospital pharmacists, including one of our customers, Andrew J. Donnelly, PharmD, MBA, FASHP, the director of pharmacy services at the University of Illinois Hospital & Health Sciences System, in Chicago, have indicated their support for the increased federal oversight. Dr. Donnellyy told us that he believes “it’s extremely important for hospitals and other health care providers to work with FDA-registeredd compounders as FDA has advised.” Not doing so, he said, could ultimately have patient safety, drug supply and compliance implications, which could affect accreditation or reimbursement from payors. Likewise, in a letter to hospitals and other purchasers issued shortly after the bill’s passage, the FDA’s Dr. Hamburgg echoed Dr. Donnelly’s comments by urging organizations to carefully consider the entity they select as their pharmacy outsourcing facility. Nonetheless, many industry stakeholders still have several questions and concerns about enforcement and requirements under the law. “The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers,” said American Society of Health-System Pharmacists CEO Paul W. Abramowitz, PharmD, ScD (Hon.), FASHP, in a prepared press statement. “However, we were disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer riskk basedd criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding.” The DQSA will continue to pose challenges for outsourcing facilities as they try to interpret and meet all the requirements of the new law and forthcoming FDA final guidance. However, entities with a history of regulatory compliance that staff qualified personnel and that invest in state-off the-art centers should be capable of adjusting to these changes. Not only will it instill confidence in the new outsourcing facility category, but it also might help prevent another national disaster like the devastating fungal meningitis outbreak. In the coming months, we look forward to contributing input to the FDA as it finalizes the DQSA guidelines. We also look forward to educating our hospital customers about this landmark legislation and how their choice of a registered outsourcing facility protects and enhances their continued commitment to superior patient safety and care.
Other than registration, the FDA’s draft guidance includes several changes, including submitting a report to the agency identifying all drugs compounded by the facility during the previous sixx month period. The legislation also requires additions to product labels, which we are in the process of completing. We did not have to start from scratch with the labeling because we already had incorporated the majority of the requirements into our internal labeling policies years ago. One significant labeling change is the addition of text reading “This Is a Compounded Drug” to be added to all products, including IV containers or their packaging. We are exploring ways to give products a uniform visible representation to this requirement, which we believe will help ensure safety and transparency in the medication administration process. We also added the DQSA-requiredd phrases in labeling of “Not for Resale” and “Hospital/Office Use Only” and incorporated the FDA’s Adverse Event Reporting website and phone number. The health care industry’s reaction to the DQSA has been cautiously optimistic, with many experts observing that the law should have granted the FDA more oversight over outsourcing facilities: As it stands, registration as an outsourcing facility is voluntary. A “Perspective” article by Boston University School of Law Professor Kevin Outterson, JD, LLM, in the Jan. —Rich Kruzynski, RPh, MBA 9, 2014 edition of The New England Journal of Medicinee (370:97-99) noted that the DQSA will be most Mr. Kruzynski is president of PharMEDium Services, LLC., effective at protecting patients’ safety if purchasers in Lake Forest, Ill.
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MAY 2014
COMMENTARY
New Foundation Cements ASA Commitment to Global Health By Alexander A. Hannenberg, MD
taught providers in remote locations to deliver safe anesthesia with very or generations, countless mem- limited resources. The society’s combers of the American Society of mitment to these members began to Anesthesiologists (ASA) have take shape in 1990, when Nicholas volunteered their skills in the far cor- M. Greene, MD, proposed the organers of the globe. Many have provided nization of an Overseas Teaching Proclinical care to those who otherwise gram (OTP). The OTP has focused would go without, and many have its work in Africa and more than 100
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volunteers have taught in Zambia, Tanzania, Uganda and Rwanda in the two decades of its existence—continuing in the present day as a collaboration with the Canadian Anesthesiologists’ Society in Rwanda. In 2009, the ASA created the Committee on Global Humanitarian Outreach (GHO) to address a broader
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range of humanitarian work including the OTP and a growing list of other initiatives. A year later, a devastating earthquake shook Haiti, and ASA members volunteered in large numbers for relief efforts organized by charitable groups and medical schools. The society itself was called on to connect volunteers with relief organizations providing surgical care and the GHO volunteer website was born. In addition, the medical center in Port au Prince had been seriously damaged, with the complete loss of its medical library. Through the generosity of Elsevier, the ASA delivered more than 100 anesthesia texts to Port au Prince in January 2011 to restore the anesthesiology teaching resources in that city. Taking Action Against Unsafe Surgery Recognition of the global crisis of unsafe anesthesia and surgery has slowly given way to action. At about the same time that the ASA established its GHO committee, another groundbreaking project was under way. Growing out of the World Health Organization’s (WHO) challenge to make surgery safer worldwide—the Safe Surgery Saves Lives campaign— an international group of experts met to develop specifications for the ideal pulse oximeter for use in low-resource settings, as well as an education program to support long-term improvement in the safety of patient care and the well-beingg of anesthesia providers on the front lines. This effort targeted the estimated 77,000 operating rooms performing more than 30 million surgeries a year without the benefit of pulse oximetry. Brought to market following a tender run under the auspices of the World Federation of Societies of Anesthesiology (WFSA), the resulting oximeter is distributed by Lifebox Foundation: the global nonprofit chaired by Harvard surgeon Atul Gawande, MD, and cofounded by WFSA, the Association of Anaesthetists of Great Britain and Ireland, Brigham and Women’s
MAY 2014
AnesthesiologyNews.com I 9
COMMENTARY Hospital, in Boston, and the Harvard School of Public Health. The Lifebox oximeter meets or exceeds performance standards for pulse oximetry and can be acquired and delivered for $250 each, a far more favorable price tag than available on the open market to small, remote facilities, and one that is approachable for many donors wishing to contribute the cost of oximeters for those in need. The ASA has been a vital partner of Lifebox from the start, and members have contributed more than $400,000 to support it. Society members have delivered the devices and provided training in four Latin American nations to date, most recently in Guatemala and Nicaragua in November 2013. The OR “oximetry gap” in these countries, along with that in more than a dozen African countries, has been nearly eliminated. Most importantly, the education program ensures that the equipment is integrated into a longterm framework for safe surgery. In its first three years, Lifebox has delivered more than 7,000 oximeters to 90 lowand middle-income nations around the globe, and provided training in their use and the use of the WHO Surgical Safety Checklist. These low-cost interventions have been demonstrated to improve surgical outcomes dramatically, making the Lifebox initiative an optimal combination of effect and feasibility. Dozens of Lifebox partners around the world have made this possible, including other national anesthesiology organizations and many nonphysician groups, including the American Association of Nurse Anesthetists and the American Academy of Anesthesiologist Assistants. In 2014, the ASA Resident Component launched its year-longg Residents Lifebox Challenge, a friendly competition among the nation’s 120 residency programs in fundraising for Lifebox. Anesthesiology residents have been remarkably creative in organizing events to support Lifebox including bake sales and comedy nights as well as including Lifebox in wedding registries.
ASA charitable work is not limited to overseas activities. Society members have been generous contributors to Hope for the Warriors, an organization dedicated to support wounded U.S. service members and their families. Four ASA-sponsored road races at the annual meetings since 2010 have raised more than $346,000 for this organization. ASA members also provided charitable support for domestic and international victims of Hurricane Sandy through contributions to the
American Red Cross and the International Medical Corps. All of this work has come together under ASA’s newest foundation, the ASA Charitable Foundation. Chartered in 2011, the Charitable Foundation is the conduit for ASA member support of charitable programs and causes important to anesthesiologists (donations are tax-deductible). With the creation of the ASA Charitable Foundation, the organization joins similar medical specialty groups in the
United States and overseas that promote the contribution of volunteerism and funding at the intersection of professionalism and philanthropy. Anesthesiology’s work in global health delivers a powerful message about the essential role of the specialty in eliminating health disparities and addressing the worldwide burden of surgical disease. For more information, visit www. asahq.org/gho/volunteer/opportunities. aspx or www.asacharity.org. ■
Protect your hard-earned reputation by managing risk. Since 1987, Preferred Physicians Medical (PPM) has exclusively insured anesthesiologists and their practices. Our policyh holders also own PPM, so helping our physician owners manage their risk iss a cornerstone of what makes us unique. PPM maintains a substantial database of more th han 11,000 adverse anesthesia events and uses this information to identify areass of risk, monitor developing loss trends, and provide cutting-edge, timely and practical anesthesia-specific risk management advice and strategies like: On-site risk management seminars for our policyholders and their staff presented by PPM in-house claims attorneeys. Exclusive online access to best practice prrotocols and documentation; white papers; current and archived issuess of Anesthesia & Law, our risk management newsletter; and other usefull information. Immediate email notification via Anesthessia Alerts of issues such as widespread drug contamination, drug sho ortages and significant changes h tto ASA standards. t d d 24/7/365 telephone access to our experien nced attorneys and claims specialists for the expert risk management advice you need, wheneever you need it. Call PPM today to learn more about how our exten nsive risk management program can help you protect your reputation.
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10 I AnesthesiologyNews.com
MAY 2014
PAIN MEDICINE
Two-Time APS Clinical Center of Excellence Takes ‘Whole Patient’ Approach To Treating Pain
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tanford University’s Division of Pain Medicine has a bedrock guiding principle for treating acute, chronic and cancer pain. “Pain is a ‘whole person’ experience,” said Sean Mackey, MD, PhD, the division’s chief. “It is an individual experience that can be managed effectively, according to the unique needs of each patient, if patients and treatment teams work together.” In its fight against pain, this two-time American Pain Society Clinical Center of Excellence Award winner employs a comprehensive interdisciplinary care model, offering some of the most advanced diagnostic tools and treatments available. The coordinated care, along with advanced research and in-depth outcomes, has made Stanford one of the leading pain centers on the West Coast.
of multiple silos of excellence, without collaboration. This leads to less-than-optimal assessment and care. We have worked hard to avoid fragmentation of services.” The division’s interdisciplinary team of more than 100 people includes clinicians, educators and researchers. Its pain physicians encompass a spectrum of primary specialties—anesthesiology, neurology, physical medicine and rehabilitation, addiction medicine, internal medicine and acupuncture—all of whom are board-certified in pain medicine. They work side by side with psychologists, physical and occupational therapists, nurses and nutritionists trained in pain management. “All of our disciplines talk to one another about a patient’s pain problem and treatment plan, allowing us to deliver the best care,” said Ravi Prasad, PhD, Command Central assistant chief of the division. “It’s a very stable and For patients coming to Stanford’s Division of Pain integrated team.” Medicine, all clinical assessments and treatments are Biweekly multidisciplinary team conferences and performed in the new 9,000-square-foot Pain Man- video conferencing with consulting physicians help agement Center, located in Redwood City, approxi- the team develop specially tailored treatment promately 25 miles south of San Francisco. grams for patients. The programs can be a single “Our desire to locate and coordinate all our services approach or a combination of therapies. in one comprehensive treatment center grew out of The pain management team also reaches out and observations of pain centers at other academic med- coordinates pain care with other specialties within ical centers,” Dr. Mackeyy said. “Most are comprised Stanford Hospital to ensure patients are pain-free. It operates a specific gastrointestinal pain program with gastroenterology; a headache program with neurology; an orofacial pain program with ear, nose and throat; a pelvic pain program with urology; and an addiction pain program with psychiatry. “Each of these programs leverages our existing platform of medical, psychological and rehabilitative resources to address the biological, psychological and social factors that impact pain,” Dr. Mackeyy said. Furthermore, the division provides pain management education at the regional, national and international levels. It currently has an outreach program with community practitioners, insurance carriers and medical practice groups to better understand their needs and challenges, and improve the quality of pain care. The division recently founded the Northern California Association of Pain Psychologists to help educate psychologists on treating pain, provide networking opportunities and share pain management strategies.
try to clean up the medication regimen, and most times, we’re able to bring people down to much lower levels of medication or no medication at all.” The Pain Management Center’s treatment approaches may include pharmacologic modalities, such as opioid and nonopioid treatments and continuous infusions. Interventional procedures can range from diagnostic and therapeutic injections under fluoroscopic or ultrasound guidance to neuroablation, spinal cord stimulation, intrathecal drug delivery and disk decompression therapies. Psychological therapies play a major role in treatment. They can include individual and group cognitive-behavioral psychotherapy, stress management, coping skills education, and mindfulness and relaxation training. Stanford also has devised targeted psychological therapies, such as control over catastrophizing, which helps patients combat the feelings that things are far worse than they actually are. “With chronic pain, there are a wide variety of emotions involved,” Dr. Prasad said. “We explain how the psychological fits into [the] whole pain process, assuring patients it’s not all in their head.” Physical and occupational therapy approaches to alleviate pain and increase functioning may involve guided stretching, proper body mechanics, core strengthening, aqua therapy, and cardiovascular and strengthening exercises. Alternative and complementary therapies can consist of acupuncture and meditation, as well as dietary supplements. To determine if these therapies are providing patients with the care they need, the division vigorously tracks outcomes. Collaborating with Stanford’s Center for Clinical Informatics, and funded through a partnership with the National Institutes of Health (NIH), it has created a patient registry to capture pain data, pain experiences and their effect on patients. “We track every patient—assessing their physical, psychological and social health, in addition to obtaining detailed information about their pain,” Dr. Mackeyy said. “We use the data to guide treatment decisions, educate patients and trainees and track treatment outcomes. Our ultimate goal is to provide this system for free to other pain centers, which will enable us to aggregate large-scale treatment data to perform cost-effective research.”
Multiple Tools To Fight Pain Stanford’s Division of Pain Medicine has a full inventory of treatment options. For the most complex and severe pain cases, its six-bed chronic pain inpatient unit, located in Stanford Hospital, is the only dedicated inpatient, academic chronic pain medicine unit in the western United States. The unit’s primary goal is to improve a patient’s physical and psychological function through an intensive medical behavioral program. “A majority of patients in the unit also have high levels of medication use, often opioids, and have become extremely dependent on them,” Dr. Prasad said. “We
Solving Pain’s Mysteries Research at the Division of Pain Medicine consists of both basic and clinical research, much of it using advanced neuroimaging, psychophysical and neurobehavioral tools to unlock the mysteries of the human pain condition. “Our mission is to ‘predict, prevent and alleviate pain,’” said Rebecca McCue, division research manager for Stanford’s Systems Neuroscience and Pain Lab (SNAPL). “Like our clinical focus, our research focus is on the whole person, too, with studies centered on the brain, behavior, psychophysics of pain processing, psychology, personality, mood and more.”
MAY 2014
AnesthesiologyNews.com I 11
PAIN MEDICINE SNAPL is a separate 6,000-squarefoot research facility, located in Palo Alto, Calif., about five miles south of Redwood City. Clinicians from the Pain Management Center and nonclinical researchers make up the research team, numbering about 30 to 35 people full-time, plus undergraduate medical students. Funded primarily by the NIH, SNAPL has some 10 to 15 research studies ongoing at any one time. A recent innovative neuroimaging study, funded by a $9 million grant from the National Center for Complementary and Alternative Medicine, is using advanced neuroimaging and other techniques to characterize the mechanisms responsible for the effect of cognitivebehavioral therapy, mindfulness-based stress reduction, acupuncture and realtime functional magnetic resonance imaging (rtfMRI) neurofeedback. rtfMRI allows a patient to observe how the brain reacts to pain as it occurs in the body. Patients, placed in an MRI machine, view their brain’s activity to pain sensations and learn techniques, such as distraction, to help control pain. The study has found that participants can change their pain experience and cut pain ratings after learning mind-control techniques. This neurofeedback approach not only has helped pain patients, but is being used to combat the symptoms of depression and addiction. A second study involving rtfMRI found that 44% of participants experienced less pain while viewing a photo of a loved one or friend. Brain images showed that the nucleus accumbens, an area in the brain involving dopamine and reward pathways, becomes much more active while viewing the photos, and this activation intersects with activity in the periaqueductal gray part of the brain’s natural opioid-based inhibitory pain control system. “These neuroimaging tools have allowed us to peer inside the human brain in ways once only dreamed about— unlocking where pain is perceived and processed, how it affects the brain, and how it can act to change our thoughts and emotions,” Dr. Mackeyy said. “For the first time, we have tools to explore the impact of pain on the brain and use the information to create comprehensive interdisciplinary treatments.” Other SNAPL research projects have investigated if low-dose naltrexone, a medication commonly used to treat opioid addiction, treats fibromyalgia. Stanford researchers have discovered that this drug has a novel way of blocking glial cells, significantly reducing fibromyalgia
pain, and improving mood and quality of life, and is well tolerated. There also are current initiatives into botulinum toxin and chronic pain, compassion meditation, pelvic pain, complex regional pain syndrome and transcranial magnetic stimulation, aimed at understanding the cortical mechanisms of low back pain.
of quality pain care. It is looking to further extend its services into other clinical specialties at Stanford Hospital and expand its reach to primary care physicians and cancer centers in the greater San Francisco area by establishing pain clinics in the community. Stanford is hoping to further effect pain management on the national level On the Move through Dr. Mackey’s role as current Stanford’s Division of Pain Medi- president-elect of the American Acadcine continues to set its sights on elimi- emy of Pain Medicine. He also serves nating the barriers that hamper delivery as co-chair of the NIH’s oversight
committee tasked by the U.S. Department of Health and Human Services to develop a national health care strategy for assessing and caring for the 100 million Americans suffering from pain. “Working together,” Dr. Mackeyy said, “we can enact the cultural transformation in pain care, education and research needed to improve the quality of life for those suffering from pain and reduce pain’s impact on society.” —Tom McDonough
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12 I AnesthesiologyNews.com
MAY 2014
PAIN MEDICINE
At Cedars-Sinai, Patients Set Goals for Pain Treatment Atlanta—Better pain management does not necessarily require more drugs, an initiative at Cedars-Sinai Medical Center, in Hollywood, Calif., has demonstrated. The health system has improved patient satisfaction by fostering collaboration between patients and providers, having patients set their own treatment goals and expectations, balancing the
needs of pain management with physical functioning and encouraging use of nonpharmacologic pain treatments. “Incorporating pain management tools specifically to engage patients in their own care and set realistic expectations for pain management, as this program has done, has the potential to significantly affect how patients perceive and experience pain,” said
Jeffrey Fudin, PharmD, BS, director of the PGY2 pharmacy pain residency at Stratton Veterans Affairs Medical Center, in Albany, N.Y., who is not involved in the program. Before the new initiative, providers at Cedars-Sinai had been doing “a really great job at reacting to patients’ pain,” said Kapil Anand, MD, assistant professor in the medical center’s
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Department of Anesthesia and Pain Management, who helped spearhead the initiative. “But we needed to become proactive, to anticipate [patients’] pain and how it might impact their functioning, and to partner with them and develop plans they could take ownership of,” said Dr. Anand, who shared details of the initiative at the 2013 University HealthSystem Consortium annual meeting (abstract F17). The first step toward a more proactive approach was to correlate pain severity and pain management with physical functioning, Dr. Anand said. His team did so by adding behaviorspecific statements to the Wong-Baker Facial Grimace Scale, a commonly used visual analog pain scale (Figure). “The new scale reminds patients and staff that pain is not a solitary thing, that it is tied to functioning,” Dr. Anand said. “The more a patient is medicated, the less mobility they tend to have, which can mean more falls and longer hospital stays, for example.” As part of the new initiative, the medical center also added “patient care boards” to patients’ bedsides. These whiteboards are where pain scores are plotted, patients’ pain medications are listed, and patients and providers write down the day’s treatment goals. “The board gives the patient care team a sense of where [the patient’s] pain is at, and that helps them set reasonable expectations for pain management together with the patient,” Dr. Anand said. An additional part of the new approach is a “comfort guide” that includes a directory of nonpharmacologic pain management options available to patients at the medical center. “The comfort guide lets patients know that we believe managing their pain is about more than just drug treatment,” said Dr. Anand, pointing to spiritual services, pet therapy and music therapy as some examples of other treatments that Cedars-Sinai offers. Sandra Sani, PharmD, a clinical pharmacist at Cedars-Sinai who helped develop the new program, said nurses provide patients with explanations of some basic pharmacologic concepts, such as routes of administration, peak concentration and duration of action. “In the past, patients would sometimes wait too long before asking for another dose because they weren’t sure when to, and so their pain would increase dramatically,” Dr. Sani said.
MAY 2014
AnesthesiologyNews.com I 13
PAIN MEDICINE 0
Verbal Descriptor Scale e
No pain
1
2
Mild pain
3
4
5
Moderate pain
6
Severe pain
7
8
9
Very severe pain
10
Worst pain possible
Wong-Baker Facial Grimace Scale
0
1-3
4-6
7-9
10
No pain
You feel some pain or discomfort but you can still complete most activities.
The pain makes it difficult to concentrate and may interfere with your ability to do certain normal activities, such as reading, watching TV, V having a phone conversation, etc.
The pain is quite intense and is causing you to avoid or limit physical activity. Cannot concentrate on anything except pain.
Worst pain imaginable.
Figure. Pain and function assessment tool.a a
This tool is intended to help patient care providers assess pain according to individual patient needs. Explain and use 0-10 scale for patient self-assessment. Use the faces or behavioral observations to interpret expressed pain when patient cannot communicate his or her pain intensity.
Source: Cedars-Sinai Medical Center
“Now they know how long the drug effect lasts and when it peaks and when their next dose is due, so the medication is administered on schedule and their pain control is much more consistent.” To assess patient satisfaction with the new approach, Dr. Anand’s team asked approximately 2,000 surgical and nonsurgical patients to respond to two items from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) questionnaire. The respondents included roughly equal numbers of patients treated before and after the intervention was implemented in May 2012. Prior to the intervention, patients felt that “hospital staff always did everything they could to help with my pain,” 77% of the time, on average. According to Dr. Anand, that percentage rose to 82% one year following implementation of the program. Before the intervention, respondents indicated their “pain was always controlled,” 62% of the time, on average; that percentage increased to 66% after the program was rolled out. Improvements of any magnitude in pain management are desperately needed, Dr. Fudin said. “A large number of emergency room visits are painrelated, and a significant number of those are because of uncontrolled pain at the time of discharge,” he said, referring to data from the National Hospital Ambulatory Medical Care Survey: 2009 Emergency Department Summary Tables (www.cdc.gov/nchs/data/ ahcd/nhamcs_emergency/2009_ed_ web_tables.pdf ). Dr. Fudin pointed to a study conducted in 2003 that included a
national sample of 250 hospitalized surgical patients and found that 88% of the patients reported moderate to extreme pain at the time of hospital discharge ((Anesth Analg 2003;97:534-540). “Unfortunately,” he said, “things have not improved significantly since then.” —David Wild Drs. Fudin, Anand and Sani reported no relevant financial conflicts of interest.
14 I AnesthesiologyNews.com
MAY 2014
CLINICAL ANESTHESIOLOGY
Ultrasound-Guided Paravertebral Blocks Best General Anesthesia for Breast Cancer Resection
W
omen with breast cancer who receive ultrasound-guided nerve blocks during resection of their tumors report less pain and better overall quality of life than those who undergo the procedure with general anesthesia, recent data show.
The randomized study of 64 women undergoing ambulatory breast tumor resection found that ultrasoundguided paravertebral blocks (PVBs) had less pain, nausea and vomiting after surgery, required fewer intraoperative opioids and left the hospital more
quickly than those who received general anesthesia. “Earlier clinical trials [of PVBs] used anatomically guided techniques and had high failure rates where patients required conversion to inhalational gas-based general anesthesia,” said
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lead researcher Faraj Abdallah, MD, assistant professor in the Department of Anesthesiology at the University of Toronto, in Ontario, Canada (see e.g., Am Surg 2003;69:213-218). “The advent of ultrasound as a means of guidance has improved nerve block success rates.” Dr. Abdallah said the study was the first randomized controlled trial examining the role of ultrasound-guided PVBs in breast tumor resection. The Toronto researchers randomized 64 women undergoing outpatient breast tumor resection to receive either ultrasound-guided PVBs and propofolbased total IV anesthesia or a standardized general anesthesia regimen using sevoflurane, fentanyl and morphine along with sham PVBs using subcutaneous saline not conducted under ultrasound guidance. The two treatment groups were demographically similar. Dr. Abdallah’s team found that PVB recipients had higher scores on the Quality of Recovery-40 (QoR-40) questionnaire, a measure of quality of life following anesthesia and surgical interventions, before discharge (mean: 146 vs. 131, respectively) and two days after discharge (mean: 144 vs. 138) (P≤0.013 for both). PVB recipients had significantly lower mean scores for postoperative
MAY 2014
AnesthesiologyNews.com I 15
CLINICAL ANESTHESIOLOGY pain based on a visual analog scale (VAS) on admission to the postanesthesia care unit—3 points lower on average (P<0.001); 2 points lower at discharge (P=0.001) and 1.5 points lower two days after discharge (P=0.001), the researchers reported. Dr. Abdallah’s team also found that women who received PVBs required a mean of 14.4 mg less morphine intraoperatively than did recipients of general anesthesia, and that fewer PVB patients needed postoperative opioids. The time to request opioids in the PVB group also was significantly delayed. Due to the reduced opioid use, PVB recipients were 77% less likely to experience postoperative nausea and vomiting than were recipients of general anesthesia (P=0.04). Women who had PVBs were discharged from the hospital an average of 50 minutes sooner than those given general anesthesia (P=0.005). Alicia Kowalski, MD, associate professor in the Department of Anesthesiology and Pain Management at the University of Texas MD Anderson Cancer Center, in Houston, who has studied PVBs for breast cancer patients, said, “The investigators did a nice job of identifying quantitative, objective outcomes that demonstrate the benefits of regional blocks.” Dr. Kowalski, who was not involved in the latest work, noted that unlike the PVB protocol used in the Toronto study, she and her colleagues at MD Anderson combine PVBs with
inhalation anesthesia and “still get the benefit of a blunted neuroendocrine stress response as well as the favorable outcomes identified in this study, due to no or minimal opioid consumption. “It would have been interesting to have a third group of study subjects receiving both PVBs and inhalational anesthesia to see what their outcomes would have been like,” Dr. Kowalski added. Although the Canadian researchers looked at
ultrasound-guided PVB placement, “in the hands of a highly skilled performer, the PVB can have equally efficacious results when performed based on anatomic guidance,” she said. Evidence suggests PVBs can reduce the risk for recurrence and metastasis following breast tumor resection, but Dr. Abdallah said measuring this outcome was beyond the scope of his study (see Anesthesiology News February 2011, page 1).
high in botic risk is When throm thrombin deficiency ti hereditary an
“Long-term recurrence studies require a different set of outcome measures, a huge sample size, few years of follow-up and massive resources,” he said. The findings were scheduled to be presented at the Canadian Anesthesiologists’ Society’s 2013 annual meeting (abstract 1647781) in Calgary, Alberta, which was canceled due to flooding. —David Wild
To learn more, visit www.thrombate.com
FELY PROCEED SA
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 t AT concentrate purified from human plasma and pasteurized to inactivate viruses, with no confirmed cases of virus transmission t In clinical studies, no cases of thrombotic complications during surgical and obstetrical procedures were reported
Easy to administer1
Convenient to store and reconstitute1
t One dosing formula t Bolus intravenous infusion (not continuous infusion) t Pregnancy category B
t 500 IU vials with sterile water for injection t Filter and transfer needles provided t Room temperature storage
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. In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia. 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.
All rights reserved.
February 2013
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16 I AnesthesiologyNews.com
MAY 2014
CLINICAL ANESTHESIOLOGY
Propofol Preferable for Sedation During Joint Surgery Study shows dexmedetomidine leads to more bradycardia, longer recovery
D
exmedetomidine (Precedex, Hospira) demonstrated its value as a substitute for propofol during shortages of the latter drug over recent years, but new findings from a retrospective single-center study suggest its role in regional anesthesia may be limited.
The results, presented at the American Society of Regional Anesthesia and Pain Medicine’s 2013 pain medicine meeting (abstract 0020), showed dexmedetomidine was four times more likely than propofol to lead to bradycardia in patients undergoing total joint replacement, and was also
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.
associated with significantly longer stays in the postanesthesia care unit (PACU). “If the results of this study are replicated, a propofol-based sedation protocol may be preferred for total joint replacement cases, because it saves costly PACU time and also carries a
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
lower risk of bradycardia, which may in turn increase the risk for ischemic stroke in susceptible patients, if accompanied by hypotension postoperatively,” said Dmitri Souzdalnitski, MD, assistant professor of anesthesiology and pain medicine at the Ohio University Heritage College of Osteopathic Medicine, in Athens. Dr. Souzdalnitski has published several studies on regional anesthesia protocols but was not involved in the latest work. During national propofol shortages in late 2012 and early 2013, Robert Hsiung, MD, staff anesthesiologist in the Department of Anesthesiology at Virginia Mason Medical Center, in Seattle, and his colleagues turned to dexmedetomidine as a propofol substitute for regional anesthesia in patients undergoing total joint replacement surgeries. For their new study, the researchers reviewed electronic medical records from 126 consecutive elective surgery patients they treated between Dec. 15, 2012 and Jan. 31, 2013. Twenty-five patients had received spinal anesthesia with dexmedetomidine and 100 had received propofol. Dr. Hsiung’s team analyzed the incidence, duration and severity of bradycardia, as well as lengths of stay in the PACU and use of rescue antiemetics. Their findings showed 75% (18 of 25) dexmedetomidine recipients experienced bradycardia, defined as a heart rate below 60 beats per minute in the PACU compared with 51% (51 of 100) of patients given propofol. After adjusting for the use of β-blockers, the dose of bupivacaine and postoperative peripheral nerve block, they determined that patients who received dexmedetomidine were four times more likely than propofol recipi recipients to experience bradycardia (odds ratio [OR], 4.02; 95% confidence
MAY 2014
AnesthesiologyNews.com I 17
CLINICAL ANESTHESIOLOGY interval [CI], 1.37-11.79; P=0.011). Patients who received dexmedetomidine also experienced longer episodes of bradycardia (69 vs. 24 minutes; P<0.001), and those bouts tended to be more severe (lowest heart rate: mean 52.7±9.95 vs. 59.7±10.7 bpm; P<0.001), Dr. Hsiung’s team found. The Seattle investigators found no significant difference in the frequency of use of antiemetic agents between the two groups of patients. However, Dr. Hsiungg reported that recipients of dexmedetomidine spent a median of 1.8 hours in the PACU compared with 1.1 hours for propofol patients (P<0.001). “From an economics standpoint, that’s a very significant finding,” he noted. Another cost consideration, he said, is that at the moment, only the branded form of dexmedetomidine is available, making it a more expensive option than propofol. Generic versions of the drug are anticipated to come to market later this year. “These results probably won’t change propofol use patterns because physicians are very comfortable with use of that drug and consider it to be safe,” Dr. Hsiungg said. Dr. Souzdalnitski said he was surprised by the finding that PACU stays were longer when dexmedetomidine was used. The majority of previous studies showed shorter or similar PACU stays when dexmedetomidine was added to conventional protocols ((Anesth Analgg 2008;106:1741-1748). And although the increased incidence of bradycardia with dexmedetomidine “was a somewhat predictable finding, the fourfold increase in incidence was striking.” Still, several weaknesses in the study limit the clinical relevance of the findings, Dr. Souzdalnitski said. “It is unclear from the study why some patients were given regional as opposed to general anesthesia. Additionally since both drugs can cause tionally, profound hypotension and dex-medetomidine can cause transient
hypertension, those would be very important outcomes to study before making any practice changes,” he said. “A well-designed, randomized controlled study comparing the two sedation protocols head-to-head may generate results that could steer practice in one or another direction,” he added. —David Wild Drs. Hsiung and Souzdalnitski reported no relevant financial conflicts of interest.
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PAIN RELIEF
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AnesthesiologyNews.com I 19
CLINICAL ANESTHESIOLOGY
Nerve Block Eases Hot Flashes
V
asomotor symptoms, more commonly known as “hot flashes,” can be effectively treated with a stellate ganglion block (SGB), researchers have found. The study is the first prospective, randomized clinical trial testing the efficacy of SGB in treating vasomotor symptoms, according to the researchers. The study divided 40 women, ages 30 to 65 years, into two groups. The experimental group received a single SGB injection with 5 cc of bupivacaine and the control group received a sham injection of saline. Women kept a diary recording the number and severity of their hot flashes. At the six-month follow-up, the women who received the SGB injection experienced a 34% reduction in the total number of vasomotor episodes, whereas the sham control group showed an 18% reduction. The improvement in the SGB group as a whole was not statistically significant. Women with mild hot flashes did not seem to benefit from the block. However, those who rated their vasomotor symptoms as “moderate” to “very severe” experienced a 52% reduction in their symptoms that was statistically significant, the researchers said. The results are consistent with previous observational findings on the effectiveness of SGB for treating vasomotor symptoms, according to David Walega, MD, associate professor of anesthesiology at Northwestern University Feinberg School of Medicine, in Chicago, who led the study. “I was ecstatic that we found not only statistically significant but clinically significant improvements in the women with more severe vasomotor symptoms who had the actual stellate ganglion injection with bupivacaine,” Dr. Walegaa said. The study also found a statistically significant improvement in cognition in the women who received the SGB injection compared with the control group, as well as a trend toward improved depression scores, which did not reach statistical significance, Dr. Walegaa said. These effects warrant further investigation, he added. Vasomotor symptoms affect more than 60% of menopausal women and can have a severe effect on quality of life. This study is a promising step forward in providing effective treatment, said Eugene Lipov, MD, medical director of Advanced Pain Centers, in Chicago. Dr. Lipov consulted on the initial design of the study, but was not
directly involved in the study itself. “There is no really good treatment for hot flashes, short of estrogen,” Dr. Lipovv said. “That’s why this is really useful, especially for women with breast cancer,” for whom estrogen therapy might not be an option. Dr. Lipovv added that the findings regarding improvements in cognition and depression are promising, not only
for women experiencing hot flashes, but for patients with post-traumatic stress disorder (PTSD). Previous case studies, including those conducted by Dr. Lipov, v have found that SGB injections can improve anxiety, depression and memory in patients with PTSD (see Anesthesiology News, September 2012, page 1). “I really believe this is just the beginning of multiple indications for the
stellate ganglion block to enhance care,” Dr. Lipov said. “And the great thing is it’s already widely available, so you don’t have to go through a lot of craziness to actually help patients.” The researchers published their findings in the March 2014 issue of Menopause. —Ajai Raj
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REFERENCE 1 4th National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society: Major Complications of Airway Management in the United Kingdom. Report and findings: March 2011. Editors: Dr Tim Cook, Dr Nick Woodall and Dr Chris Frerk.
Teleflex, ARROW, Hudson RCI, LMA, LMA Supreme and Rusch are trademarks or registered trademarks of Teleflex Incorporated or its affiliates.© 2014 Teleflex Incorporated. All rights reserved. 2014-3019
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CLINICAL ANESTHESIOLOGY CONTINUED FROM PAGE 1
Yet even with active warming during surgery, redistribution hypothermia and excessive heat loss combine to make many patients at least transiently hypothermic. Although studies have documented the incidence of intraoperative hypothermia in a variety of populations, the new work is the first to detail intraoperative temperature patterns in a large general population of noncardiac
surgical patients, according to the investigators. It is also the first to evaluate hospital length of stay and transfusion requirements over a broad unselected population. “There are many randomized trials showing that mild hypothermia worsens outcome,” said Daniel I. Sessler, MD, Michael Cudahy Professor and chair of Outcomes Research at Cleveland Clinic, in Ohio. “Our observational study nonetheless provides novel information. First, the
results generalize better. The randomized trials focused on small subsets of high-risk patients, whereas our analysis included a broad array of inpatient operations. Second, most of the randomized trials date to the 1990s, and medical practice has since changed considerably. And third, the randomized outcome trials all compared passive insulation to forced-air warming. In our current analysis, all patients were actively warmed per the current standard of care.”
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The investigators extracted data from the most recent visit of 143,157 of the institution’s patients scheduled for noncardiac inpatient surgery between April 1, 2005, Daniel I. Sessler, MD and Feb. 15, 2013. Records were included only if the anesthetic lasted at least one hour, forced-air warming was used and core temperature was measured in the esophagus. Rather than assess final intraoperative temperatures to determine the incidence of hypothermia, the researchers used a time-weighted measurement of core temperature. The primary exposure was integrated area under the curve incorporating both duration and severity of hypothermic exposures into one value. Estimates were obtained for one-degree temperature bands ranging from 34 C to 37 C. “All previous studies were based on final intraoperative temperature,” Dr. Sessler explained. “But final temperature overestimates temperature in actively warmed patients. It is therefore also important consider the duration and severity of hypothermia. Our exposure index includes both considerations.” Prolonged Low Body Temperatures As Dr. Sessler reported at the 2013 annual meeting of the American 38
Core Temperature, °C
COLD
37
36
35
0
1
2
3
Sample Size
Time After
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Figure. Body temperatures during surgery, including hypothermia.
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AnesthesiologyNews.com I 21
CLINICAL ANESTHESIOLOGY Society of Anesthesiologists (abstracts 1267, 1272 and 2230), 58,814 patients met all criteria. Approximately onethird of patients had core temperature of 36 C or lower for at least one hour; 8% were below 36 C for more than three hours. Perhaps most alarming , the researchers said, 5% of patients had core temperatures of 35 C or lower for at least one hour. The incidence of hypothermia was greatest one hour after induction, and then progressively improved. “Even with forced-air warming, our results indicate that a fair fraction of patients still become hypothermic,” Dr. Sessler said. “In fact, almost 10% of patients were distinctly hypothermic and remained near 35 C at the end of surgery. This is a degree of hypothermia that has been shown to cause major complications in randomized trials.” Furthermore, the analysis showed that both the duration of hospitalization and red blood cell transfusion requirements increased for patients whose core temperature dropped below 35 C. Tackling this issue, Dr. Sessler concluded, might involve actively prewarming patients or increasing the efficacy of intraoperative warming systems. “Heat transfer by most any cutaneous warming system is a linear function of surface area,” he said. “Simply increasing the surface covered by forced air, for example, will augment its efficacy.” Co-investigator Andrea Kurz, MD, professor and chair of general
anesthesia at Cleveland Clinic, agreed that proactive measures might help address the issue. “These studies show that hypothermia still exists,” Dr. Kurz said. “There is a lot less [hypothermia] than there was 20 years ago. But despite the fact that most patients are now normothermic at the end of surgery, many still experience periods of intraoperative hypothermia. Even short periods apparently worsen outcomes; we therefore still need to improve this aspect of our practice.”
r Induction, h
5
temperature at the end of the procedure, and largely ignored what happens during the procedure. We don’t judge the quality of our care by looking at these vital signs just at the end of the case. So why should we not focus on temperature throughout the entire case as well? This is a big issue, and I’m glad Dr. Sessler and his colleagues examined what happens between the beginning and end of a case.” —Michael Vlessides
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Steven M. Frank, MD, associate professor of anesthesiology and critical care medicine at Johns Hopkins Medical Institutions, in Baltimore, said that although he was not surprised by the incidence of hypothermia found in the study, he found it hard to believe how rarely the vital sign has been studied. “Ever since the late 1990s, we’ve recognized the importance of maintaining body temperature,” Dr. Frank told Anesthesiology News. “But everybody has been focused on the core
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CLINICAL ANESTHESIOLOGY POISE-2
CONTINUED FROM PAGE 1
Daniel I. Sessler, MD, Michael Cudahy Professor and chair of the Department of Outcomes Research at Cleveland Clinic, in Ohio, who helped conduct the trial, said anesthesiologists should pay attention to the POISE (PeriOperative ISchemic Evaluation) findings because 8% of adults over the age of 45 years who undergo noncardiac surgery experience a postoperative MI. What’s more, 80%
of postoperative MIs are clinically “silent,” causing no increase in troponin, no chest pain, shortness of breath or other telltale indicators of a heart attack. “You might think the subclinical ones are less important, that they’re just a biomarker. But the mortality is exactly the same” as with a symptomcausingg MI. “One in 10 patients who has [a postoperative MI] is dead within 30 days, whether clinically evident or not.”
Some experts feared the data on aspirin might prompt some clinicians to advise their patients taking the drug prophylactically to stop doing so before elective surgery. C. David Mazer, MD, an anesthesiologist at the University of Toronto, in Ontario, Canada, said that would be a mistake. “Clinicians should examine this and other data carefully when considering the risks of withdrawing aspirin against the risks for perioperative bleeding, especially in patients at risk
Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer. Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery. This activity is jointly sponsored by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.
Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade. Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.
for perioperative thrombotic events,” Dr. Mazer said. Two POISEs, Three Strikes In the POISE-1 trial, researchers found that perioperative administration of β-blockers did prevent heart attacks but caused more strokes, leading to an increase in total mortality among surgery patients who received the medication. The POISE-2 trial looked at a follow-up question: Would the administration of low-dose clonidine or aspirin do what β-blockers could not? The aspirin arm of POISE-2 included 10,010 patients with, or at risk for, atherosclerosis, who were undergoing noncardiac surgery at hospitals in the United States and Canada. Patients were randomly assigned to receive 200 mg of aspirin or a placebo immediately before their procedures. Those who were taking aspirin preoperatively (n=4,382) took 100 mg of the drug or a placebo for seven days after surgery. Those who were not taking aspirin preoperatively (n=5,628) took 100 mg aspirin or a placebo for 30 days thereafter. The clonidine arm included the same 10,010 patients, randomized to receive 0.2 mg per day of clonidine or placebo immediately before surgery
Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin
Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois
Challenge Questions 1. What would you do next? 2. What potential postoperative risks does this patient face?
Access this activity at www.cmezone.com/nmb1
‘One in 10 patients who has [a postoperative MI] is dead within 30 days, whether clinically evident or not.’ —Daniel I. Sessler, MD
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AnesthesiologyNews.com I 23
CLINICAL ANESTHESIOLOGY and by patch for 72 hours after the procedure. The primary outcome was a composite measure of death or heart attack within 30 days of surgery. Of the patients given clonidine, 367 met the primary outcome compared with 339 in the placebo group, a statistically insignificant difference, according to the researchers. The results were similar for a secondary outcome of stroke, death or heart attack, the researchers found. Patients on clonidine were more likely to experience “clinically important” bradycardia and hypotension, the latter of which was an independent predictor of MI. The findings from the aspirin arm of POISE-2 mirrored the results with clonidine. Of the patients who received aspirin, 351 (7%) experienced an MI after surgery compared with 355 (7.1%) in the placebo group. However, aspirin patients were somewhat more likely to experience major postsurgical bleeding than those who received placebo (hazard ratio, 1.23; P=0.04), the researchers reported.
University of Michigan, in Ann Arbor, wrote that the results of the POISE studies “taken together offer credibility to a calculated strategy of decreasing heart rate while avoiding perioperative hypotension.” However, they wrote, the studies do leave substantial uncertainty, “including best practice in those who have undergone any percutaneous coronary intervention”—a group largely absent from the trial population. “Further progress in perioperative
medicine may depend on the implementation of strategies that successfully address one pathophysiological mechanism of perioperative myocardial infarction without being limited by another.” Is prevention of postoperative MIs an unrealistic goal for clinicians? Dr. Sessler said no. “It’s possible that these heart attacks are related to surgical responses that are unmodifiable, but that’s not my guess,” Dr. Sessler told Anesthesiology News. “There are
things that anesthesiologists can do to moderate those responses. We just don’t know how yet. We’re working on it and eventually I think we’ll find some drug or treatment or anesthetic method that does reduce postoperative MI, but aspirin and clonidine are not the answer.” Researchers will take another crack at the question with the POISE-3 trial, Dr. Sessler said. That study is still being designed. —Adam Marcus
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PRN VIOLENCE
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like access to guns and economic changes. Hospitals are no different,” said Marilyn Hollier, director of hospital and health center security services at the University of Michigan Hospitals and Health Centers, in Ann Arbor. Ms. Hollier also serves as the president of the International Association for Healthcare Security & Safety (IAHSS). Shootings happen very rarely in hospitals or on hospital property. In an often-cited comparison, a health care worker has a greater risk for being struck by lightning than being shot on the job ((Ann Emerg Medd 2012;60:790-798). Despite this, shootings do happen, and they occur more often in hospitals today than they did a decade ago. This shift has made health care workers, hospital administrators and security experts look at ways to prevent, and practicee for, these dire situations. “Active shooters in hospitals are the 800-poundd gorilla in the room that no one wants to talk aboutt because everyone is scared of it,” said Andrew Dennis, DO, a trauma surgeon and chair of resuscitative and prehospital traumatology at Cook County Hospital, in Chicago. Dr. Dennis is a Chicago SWAT officer and director of medical operations of the Cook County sheriff ’s office. “But hospitals can’t bury their heads to the reality. You have to accept the risk for the environment you’re in. The fact is that you have a higher risk of being stuck with a needle than being involved in an active shooter situation in your hospital. But do I still think that we need training to give people realistic expectations about what could occur and what the response will be? Absolutely.” Dr. Dennis works with the Chicago police department in its emergency planning, and lectures to schools and teachers around the country about active shooter preparedness. Like teachers, he said, hospital staff needs to be trained to deal with active shooter situations. “People will always panic,” he said. “They freeze. But they will sink to the level of their training. So if you can give them a fundamental level of training and keep it alive by practicing, that’s the best you can do.” High Stress Can Breed Violence Violence always has been part of the emotionally charged environment of a hospital. Stress levels are high in health care facilities as families grapple with life-and-death issues. A significant proportion of inpatients and outpatients suffers from mental illness. There’s a long history of violence from the streets spilling over into hospital emergency departments. The difference is that the degree of violence in hospitals has intensified over the past eight years. “The country has experienced a definite uptick in violent episodes in hospitals,” said Esmeralda Valague, the regional emergency preparedness manager at Christus Santa Rosa Health System, in San Antonio. It’s difficult to measure that uptick, she explained, because many violent incidents in hospitals are unreported. The Joint Commission started tracking crimes in hospitals in 1995. In the two decades since, data collection about hospital violence has improved, a change that may account, at least in part, for the growth in known violent incidents. Hospitals
‘People will always panic. They freeze. But they will sink to the level of their training. So if you can give them a fundamental level of training and keep it alive by practicing, that’s the best you can do.’ —Andrew Dennis, DO
experienced significant escalations iin assault, ault rape and homicide between 2007 and 2010, according to a 2011 report by the Joint Commission. A survey of health care security professionals suggests that this trend has continued since 2011. According to the U.S.-based IAHSS, the number of simple assaults, rapes and sexual assaults in hospitals rose annually since 2010, representing a 37% increase in three years. Eight homicides were reported at health care facilities in 2012. It’s important to note that the survey’s information is incomplete: It does not break down violence by country, although multiple countries were represented. Furthermore, many facilities do not participate in the survey because of concerns about potential liability and negative publicity. Even if the exact number of violent incidents is unknown, there is no question that the hospital setting poses a “unique security challenge,” Ms. Hollier said. “The situation is different at every hospital. But, in general, the majority of violence in a hospital is targeted acts, not random. Nurses are often the No. 1 target. It’s things like people lashing out at them because they don’t think they are getting the right kind of service.” Experts say firearm violence accounts for a small percentage of overall crimes in hospitals, but these events are happening with increasing regularity. “When you consider the number of people who go through hospitals and clinics in the United States in a single day, the number of events involving guns is miniscule; that’s important. But, exponentially, these have increased,” said Daniel J. Holden, director of hospital security for a U.S. security firm and immediate past chair of the security and safety committee of the Hospital Association of Southern California (HASC).
Statistics from the Hospital Employeee Health Association indicate that about 3% of hospi hospitals experiencedd a shooting h ing incident between 2000 and a 2011. Another study identified 154 shootings at U.S. hospitals over the same 12-year period, ranging from a low of six shootings in 2000 to 28 in 2010 ((Ann Emerg Medd 2012;60:790-798). Gun violence in hospitals occurred far more frequently in the second half of the study: A mean of nine shootings was reported annually in the first six years of the study; that rose to 16.7 per year in the latter half. A caveat: The increase was limited to firearm violence that occurred outside of hospital walls but still on hospital grounds. Shootings on hospital property increased from 2 per year in 2000 to 8.5 per year just over a decade later. At the same time, shootings within hospital walls remained relatively stable, at 7 versus 8.2 per year. Over the 12 years of study, 59% of shootings took place inside the hospital and 41% outside on hospital grounds. No matter how one looks at the numbers, firearm violence in hospitals is rare compared with other forms of workplace violence, the study investigators stressed in their conclusions: The Department of Labor, Bureau of Labor Statistics indicated that less than 2% of workplace shootings involve the health care sector, a percentage that is similar to that of college and university campuses that reported 1.5% ‘active shooter on campus’ incidents within a five-year period and is otherwise lower than the percentage of lightning-related deaths.” The study was conducted by physicians at Johns Hopkins Hospital in Baltimore, itself the site of a recent high-profile episode of hospital gun violence. In September 2010, a gunman, upset over news about his mother’s medical condition, opened fire inside the hospital, wounding an orthopedic surgeon before turning the gun on his mother and then see violence page 26
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PRN VIOLENCE
32% were in current or estranged intimate relationships; 25% were current himself. In the aftermath of the shoot- or former patients; and 5% were curing, physicians set out to characterize rent or former employees. In only 13% gunfire in hospitals. They wanted to of events was the association not obvifind patterns that could help prevent ous. Most of the time, a clear motive was identified: a grudge or revenge future deaths. The physicians discerned a handful (27%), suicide (21%) or ending the of patterns. Hospital size and location life of an ill hospitalized relative (14%). were not predictors of violence. The Escape attempts by patients in police majority of perpetrators, 91%, were custody accounted for 11%. In nearly men, representing all ages. Most had a one-fifth of cases, the perpetrator did personal association with their victims: not bring his or her own firearm. In 8% CONTINUED FROM PAGE 24
of cases, the perpetrator took the gun of a security or police officer. “Health care providers and employees are unlikely to be victims of indiscriminate violence,” the researchers stressed. “In fact, unlike those in education campuses, most hospital shootings have an intended specific target.” The study reported that only the emergency department appeared to be associated with a higher risk for shootings. Nearly one in four shootings in the emergency department was linked
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to a person in custody who was being guarded or watched by armed security personnel. The authors concluded that impenetrable hospital security in an open society “represents a particular challenge” and “zero risk is not achievable.” That concept of an “unachievable” zero risk is changing the way health care administrators and workers think about security. Today, hospitals and medical centers are stepping up their emergency preparedness efforts, with many institutions now planning specifically for active shooter scenarios. In March, HASC conducted a major active shooter drill that involved more than 230 participants. The day started with an actor playing the role of an active shooter stalking the hospital’s emergency department and the administrative offices. That was followed by intensive discussion with participants on responding to an active shooter. In Massachusetts, major hospitals have adopted and practice “Code Silver” protocols. In November 2013, Brigham and Women’s Hospital, in Boston, created a 10-minute “Active Shooter Preparedness Training” video that gives step-by-step instructions on the proper procedures for dealing with a shooter. The video was shown to 16,000 employees, and is now part of the hospital’s yearly training requirement. The video voiceover states that the odds of an active shooter scenario are “quite remote. … But the consequences are so potentially catastrophic that it is important to be prepared so we can protect our patients, their families, our visitors and each other,” according to the video. “As health care providers, we
At a Glance The number of simple assaults, rapes and sexual assaults in hospitals rose annually from 2010, representing a 37% increase in three years.
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Nurses are often the No. 1 target of hospital violence. Most perpetrators of hospital violence had a personal association with their victims.
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Most of the time a clear motive was identified: a grudge or revenge (27%), suicide (21%) or ending the life of an ill hospitalized relative (14%). @anesthesianews anesthesiologynews
MAY 2014
AnesthesiologyNews.com I 27
PRN ‘Nurses are often the No. 1 target. It’s things like people lashing out at them because they don’t think they are getting the right kind of service.’ —Marilyn Hollier
embrace a duty of care commitment that compels us to be more than just survivors but protectors as well. That’s why thinking about your actions in advance is so important.” The Brigham video touched on an issue of major concern for physicians, nurses and other health care workers: What is their responsibility to protect their patients if an active shooter targets their hospital? There is no standard for how health care workers should respond if an active shooter barges into their place of work. Adding to the confusion, discrepancies exist among agencies and professional bodies regarding care providers’ obligations in such an event. “The Texas Board of Nursing says that if you abandon your patients, even for an active shooter threat, it may be investigated for disciplinary action, and life safety (fire) codes stress open access for egress, not ease of lockdown,” Ms. Valague said. “On the other hand, you have [the U.S.] Occupational Safety and Health Administration and law enforcement agencies saying that workers need to protect their own life and safety first so they can help others later.” Every situation is different, but the goal should be to limit the number of casualties, Mr. Holden said. “Under an active shooter situation, the patient abandonment issue would probably not be, in my opinion, as stringently enforced, provided you follow your organization’s protocols and training. [In] the end, what purpose do you fulfill if you try to run back to help your patient and you become a victim? Who is going to help the patients now?” Dr. Dennis recommended that health care workers watch “Run. Hide. Fight.” a video produced by Houston’s Office of Public Safety and Homeland Security. The video, which has received more than 2 million views on YouTube, recommends that people flee, hide, or as a last option, fight in the event of an attack.
“It is by far the easiest thing to remember,” Dr. Dennis said. “It says that if you are involved in an active shooter [situation], the first thing you should do is run. If you can’t run and flee the scene, then you should hide. Turn the lights out, barricade the door, become silent. As a last resort, fight. You have to remember that the goal is to minimize casualties as much as possible. You want to preserve your skilled workforce and as many people as you can.”
He added that hospitals need a plan that is unique to their institution. Planning and organizing active shooter drills is expensive and timeconsuming, and can be frightening to the public and the staff, he acknowledged, but “you’re not going to know what to do until you drill this for real. It should be as automatic as fire drills or disaster response.” —Christina Frangou
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Will Hospitals Be Ready To Get Smart?
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hysicians routinely scrutinize their patients’ medical information to make clinical determinations, but the process is labor-intensive, replete with redundancies and prone to human error. New research, in combination with mobile medical monitoring techniques, points to the possibility of a smart alert technology that could revolutionize patient
management—if hospitals can adapt to it. California researchers have found that a single metric in patients undergoing total knee arthroplasty (TKA)— use of opioid analgesia before admission—strongly predicts the need for additional postoperative pain management and extended stays in the hospital. That’s proof, they said, that
selected data points have the power to flag patients who may require additional interventions. “This is not novel. We have a lot of data to show that patients who require pain medication are going to be more challenging to manage postoperatively,” said Bassam Kadry, MD, clinical assistant professor of anesthesiology, perioperative and pain medicine at
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Stanford University School of Medicine, in Stanford, Calif., who presented the findings at the 2013 annual meeting of the Bassam Kadry, MD American Society of Anesthesiologists (abstract 2261). “We know that the best intervention to control pain is early intervention; but in the hospital environment, coordination of early intervention is itself a challenge. For these TKA patients, the management of their pain is administered after the fact, even though we have a good idea of who will require additional support even before surgery.” In the latest study, Dr. Kadryy and his colleagues examined the records of 1,611 TKA patients, 1,122 patients undergoing total hip arthroplasty (THA) and 169 patients undergoing total shoulder arthroplasty (TSA). They found that patients who had used opioids before surgery (including methadone, fentanyl, oxycodone [≥40 mg] and morphine [≥60 mg] stayed in the hospital significantly longer than those who had not taken the painkillers. The median length of stay was 0.55 days longer for TKA patients using opioids (P<0.0001), 0.57 days longer for THA patients (P=0.013) and 0.9 days longer for TSA patients (P<0.0001). After analyzing the method of anesthesia, the researchers found that TKA patients with preadmission use of opioids who received combined general and regional anesthesia had a 0.8 day longer stay in the hospital (P<0.0001) than opioid-naive patients. Using diagnostic codes, the Stanford researchers determined that most of the patients taking opioids before surgery were doing so to treat chronic pain. Dr. Kadryy said he envisioned using these selected data points, such as preadmission opioid use by TKA patients, to develop algorithms similar to those used in the financial sector to detect credit card fraud and arbitrage opportunities. The algorithms could send smart alerts to physicians warning them of potential problems even before they become clinically evident. “The idea is that we are trying to emulate how [a] physician analyzes information for a particular diagnosis,” Dr. Kadry said. “How do you
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PRN optimize filters and alerts to give you accurate signals and limit both falsepositives and false-negatives? We want to develop technology that could look [and] analyze data for ‘fingerprints’ of patients that fulfill the same set of criteria that we would use to make diagnoses as physicians.” One of the first steps to establishing such a system is to define the clinically relevant data points that can flag patients who are likely to require interventions. “The data we use must be ‘vital’—valid, important, timely, actionable and low-cost,” Dr. Kadry explained. But before such systems can be put in place, another major hurdle must be cleared: the collection and integration of those data. Outdated monitoring systems remain one of the biggest obstacles to i mp l em entati o n of integrated data systems and smart alert technology in health care settings. Most monitors used in hospitals do not store, integrate or share the data they generate. If medical monitoring devices store data at all, it is on their manufacturers’ own private networks. Collecting the data and connecting and integrating those networks is prohibitively expensive and complicated. “Medical devices today—most of them—live in the world of kingdoms. Each company has its own kingdom,” said Leo Montejo, MD, founder and CEO of WiCis, a company that manufactures wearable mobile health, or “m-health,” devices. “These systems haven’t changed in 20 years.” M-health devices, in contrast to the monitors used in most health care
settings today, are expressly designed to store and share data seamlessly across many different platforms. With m-health devices, multiple medical parameters such as blood glucose, temperature and electrocardiography—and medical information such as prescriptions and medical history— can be shared across multiple platforms, just like fitness information can be shared through social media with devices like Fitbit or Nike+. Dr. Montejo said he expected consumers to usher in an m-health revolution in the next several years that will force recalcitrant health care providers to adopt m-health devices. “It’s not going to be driven by the hospitals,” he said. “They are way behind the curve on this.” But changes in health care delivery ultimately may force institutions to make the leap. “The reality is that a lot of the processes in health care have a lot of complexity, and variability will never go away,” Dr. Kadry said. “Developing a system that can balance standardizing processes, minimize variability, recognize opportunity and leverage smart alerts to drive change is key.” Changes in health care payment structure will put additional pressure on hospitals to streamline services and minimize complications, because pay will be based on quality of care, not quantity, he added. “I think the tipping point is going to come when clinical outcomes determine a bigger chunk of our incomes,” Dr. Kadry said. “Eventually, this is going to happen. It’s just a matter of when is going to be the right time.” —Keely Savoie
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CDC: Poor Abx Prescribing in Hospitals Proving Deadly
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n 1945, upon accepting his sshaare of the Nobel Prize in Physiology or Mediccin ne for the discovery and isolation of penicillin n, Alexander Fleming delivered an ominous warn ning : If you use antibiotics too much, the bad baccteeria could grow resistant and the drug’s lifesavin ngg power could diminish. The U.S. Centers for Diseasee Control C and Prevention (CDC) is among man m ny organizations now confirming Fleming’s ffeaars and issuing a prudent call to action. “The more we use antibiotics, the t more fuel we provide to the fire of reesistance,” said Arjun Srinivasan, MD, assocciaate director for Healthcare-Associated In I fection Prevention Programs in the CDC C’’s Division of Healthcare Quality Promootiion. In its March “Vital Signs” reeport (http://1.usa.gov/NvLJsU), the CDC underscored the importance of an nttibiotics in saving lives, but noted a paandemic of poor prescribing practiicees that is putting patients at unneccesssary risk for drug-resistant infeec-tions and deadly diarrhea. Thee paucity of new antibiotics in thee development pipeline has further heightened the urgency for improved use of today’s drugs. The CDC implored hospitals nationwide to respond to this public health crisis with strong antimicrobial stewardship programs (ASPs). At the core of that effort, the CDC noted, are pharmacists. “They are true leaders in this area,” said Dr. Srinivasan, senior author of the new report. “We’re excited to partner even more with the pharmacy community to help expand the impact and work of clinical pharmacists in stewardship.” Advertisement
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The first red flag uncovered by Dr. Srinivasan’s team in their survey (http://1.usa.gov/1phPWMB) was the high frequency of antibiotic prescribing. Of patients at 323 hospitals in the MarketScan Hospital Drug Database in 2010, 55.7% received antibiotics during their hospitalizations. Further analyses suggested that this rate poses an unnecessary risk to public health, as well as to a hospital’s bottom line. Antibiotic prescribing could be improved in about 40% of the most common prescribing scenarios, according to data from the CDC’s Emerging Infections Program on 11,282 patients at 183 hospitals in 2011. Antibiotics to treat urinary tract infections and vancomycin often were given to patients without proper diagnostic testing or beyond the time when they should have been discontinued, according to the CDC data. The CDC also found that about one-fourth of Clostridium difficile infections could be prevented if use of broad-spectrum antibiotics was cut by 30%, based on 19 hospitals reporting to the National Healthcare Safety Network (NHSN). “Healthy bacteria get wiped out and that allows C. difficile to really flourish,” Dr. Srinivasan explained. Great variability in prescribing practices also was evident in the NHSN. Doctors in some hospitals prescribed three times as many antibiotics as doctors in similar departments at other centers. “Whenever you see variations that are that significant, it suggests there may be room for improvement,” Dr. Srinivasan said. It is not yet clear which hospitals in the databases had ASPs, he noted. In fact, no statistics exist on the overall prevalence of such programs in the United States.
Room m for f Growth Ronald Polk, Ph haarmD, a research professor in the Departmen ntt of Pharmacotherapy and Outcomes Scien ncce at the Virginia Commonwealth Univveersity School of Pharmacy, in Richmond, ssaaid the CDC’s findings of large and unexxpplained variability in antibiotic use acrrooss hospitals matches well with his ow wn n experience in monitoring a consorrttium of academic medical center hosppiitals. He said he has also found thaatt most academic institutions do ruun formal ASPs. “It’s less common nw when you get into nonacademic h hospitals,” noted Dr. Polk, who haas worked extensively with ASPs oovver the past decade. “All hospitaals ought to be engaged in antim microbial stewardship, and pharrm macists are a key element of tth hat team.” Dorothy McCoy, PharmD, D BC CPS, an infectious disease pph harmacist at Hackensack University Medical Center U and a clinical associate professor at Rutgers Univversity, New Brunswick, both in New Jersey, highlighted the important effects that ASP pharmacists can have on antibiotic prescribing—beginning the moment an order is placed. ASP pharmacists may, for example, call a prescribing physician to address the required approval for a restricted-use antibiotic, she said, initiating a second-thought process for the doctor: “Do I really need to use this antibiotic? Is this the most appropriate one to use right now?” Pharmacists also can play the lead role in reassessment after the first 48 hours of treatment, Dr. Srinivasan said. During this “antibiotic timeout,” he noted, they might round with the clinical team to determine if the therapy is still needed—if it is, in fact, the right therapy—and if it has been prescribed at the correct dose and for the optimal duration. As part of their ASP, Dr. McCoy’s team, which includes Arpi Kuyumjian, PharmD, and Rani Sebti, MD, lead a range of further efforts to bolster antibiotic-resistance awareness and proper prescribing—from an ASP screensaver on all of the hospital’s computers and an information table in the cafeteria during the CDC’s Get Smart About Antibiotics Week, to an annual investigation into the hospital’s use of one specific drug. Most recently, Dr. McCoy said, the use of daptomycin (Cubicin, Cubist) fell under their scrutiny. “We saw an increase in how much we were spending on the drug, which is a restricted agent at our hospital,” she said. “We wanted to take a closer look to make sure it was being used appropriately and for the indications that we had in our hospital’s guidelines.” As it turned out, daptomycin was being used appropriately for the indication of interest: skin and skin structure infections. Still, the team continues
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PRN to keep a close eye on when and how doctors prescribe the restricted agent, she stressed. In some cases, the collaboration of the ASP with infection control and the microbiology laboratory has reduced the use of various antibiotics, and thereby leveled off rates of resistant organisms, Dr. McCoy said. The improvements also have provided another welcome perk for the hospital. “We’re spending less money every year on antibiotics,” she said. The CDC’s latest release lists seven elements that hospital ASPs should adopt, at a minimum, including these types of strong educational programs and oversight for evaluating, tracking and reporting prescriptions and resistance patterns. Also among their core recommendations is to appoint a pharmacist leader as the drug expert. Just how an individual institution’s ASP will look, and the roles played by its pharmacists, will depend on the types of patients, available resources and expertise, noted the CDC. Dr. Polk agreed that ASP strategies will vary between hospitals. Yet teaming up with other hospitals, he added, can maximize each program’s individual effect. “Stewardship programs are now talking to other stewardship programs,” he said. One key benefit of a consortium, such as the approximately 100 academic medical centers affiliated with the University HealthSystem Consortium that Dr. Polk and his colleagues have been working with for more than 10 years, is the ability of a hospital to benchmark its antibiotic use against other hospitals. For example, his research has shown that in 2009, antibiotic use at Tufts Medical Center, in Boston, was roughly 20% lower than at similar centers, after adjusting for differences in patient mix. The ASP medical directors, Shira Doron, MD, and Gretchen Volpe, MD, and the ASP pharmacist, Kirthana Beaulac, PharmD, continue to monitor usage to assure its appropriateness. “Hospitals with higher rates of adjusted usage compared with their peers then have strong incentive ... to evaluate and reduce their use where appropriate,” Dr. Polk said. Of course, antibiotic overuse and misuse is not confined to hospitals. “We know there is a definite need and certainly room for improvement in both human and animal sectors,” Dr. Srinivasan said. “Making those improvements will work hand in glove to improve resistance.” The benefits of better stewardship
of antibiotics, whether for humans, livestock or farmed fish, Dr. Polk added, could extend beyond just lowering risks for drug-resistant infections. “There is emerging evidence that antibiotic exposure in children may be linked to altering gastrointestinal bacteria, which may predispose them to a variety of things we would never have thought were linked, such as obesity,” he said. Still, concerns over a possible return to the “preantibiotic era,” a time when
many infections may be untreatable, are far from new. “This has not caught us by surprise,” Dr. Polk said, referring back to Alexander Fleming’s warnings in the 1940s. “But now we’ve gotten to the point where the problem is looming so great that action has to be taken.”
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—Lynne Peeples None of the sources reported relevant financial conflicts of interest.
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Project Targets Unnecessary Practices in ICU
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ritical care organizations have announced a list of five practices in the ICU that should be questioned because they are costly, may not always be necessary and could, in fact, be harmful. The project is part of the “Choosing Wisely” initiative of the American Board of Internal Medicine (ABIM) Foundation, which has challenged
physicians to look at various medical interventions that are overused and may add needlessly to the country’s health care expenditures. Some critics have panned the program as an infringement on a physician’s right to make decisions about care, but its supporters—and there are many—say this is a case of physicians proactively setting the standard
for what is considered high-qualityy but cost-effective health care. “It should be clear to everyone in the audience that rationing is unavoidable,” said Scott Halpern, MD, assistant professor of internal medicine at the University of Pennsylvania Perelman School of Medicine, in Philadelphia, as he presented the list in January at the Society of Critical Care
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Medicine’s (SCCM) 2014 Critical Care Congress. “Health care needs are boundless. You cannot reconcile boundless needs to bounded funds,” he said. The recommendations were developed and endorsed by the American Association of Critical Care Nurses, the American College of Chest Physicians, the American Thoracic Society and the SCCM. A task force representing these organizations identified the five evidence-based recommendations that they believe will help physicians, patients and families make decisions together about the most appropriate care for a patient. The measures consist of the following: 1. Don’t order diagnostic tests at regular intervals, such as every day, but rather in response to specific clinical questions. “The routine ordering of tests increases health care costs, does not benefit patients and may in fact harm them,” according to the statement. 2. Don’t transfuse red blood cells in hemodynamically stable, nonbleeding ICU patients with a hemoglobin concentration greater than 7 g/dL. 3. Don’t use parenteral nutrition in adequately nourished critically ill patients during the first seven days of an ICU stay. 4. Don’t deeply sedate mechanically ventilated patients without a specific indication and without daily attempts to lighten sedation. 5. Don’t continue life support for patients at high risk for death or severely impaired functional recovery without offering patients and their families the alternative of care focused entirely on comfort. The last recommendation may be the most controversial, said Hannah Wunsch, MD, MSc, assistant professor of anesthesiology at Columbia University College of Physicians and Surgeons, in New York City, but it’s “the one, perhaps, that the task force felt the most strongly about. “Some patients receive lifesustainingg therapies due to clinicians’ failures to elicit preferences and provide recommendations [about end-off life care],” she said. “We felt that, whether or not there are large resulting savings with this item, it was very important as a general topic to be included and [it] opens up everybody to a dialogue on the issue.”
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PRN Attendees at the meeting offered wide support for the guidelines. One commentator noted, however, that more evidence is needed on withdrawal of end-off life care, citing a Canadian study that demonstrated a higher rate of mortality at trauma centers following withdrawal of lifesustainingg therapy, particularly in the early phase of care. The authors of the study called for caution regarding prognostication and early withdrawal of life-sustaining therapy (CMAJ 2011;183:1581-1588). Dr. Wunsch emphasized that the guideline stresses early discussion with patients and families about end-off life care issues and does not call for premature withdrawal of care. One of the key elements of the “Choosing Wisely” list is the emphasis that it places on discussions between physicians and patients and their families. Jeremy Kahn, MD, associate professor of critical care, medicine and health policy, University of Pittsburgh School
‘It should be clear to everyone in the audience that rationing is unavoidable. Health care needs are boundless. You cannot reconcile boundless needs to bounded funds’ —Scott Halpern, MD
of Medicine, said many clinicians often feel the ICU environment is too complex to heavily involve patients in decision making. “But we can use this to better educate critical care patients and their families. Perhaps we’re not giving families enough credit.” Consumer Reports, a partner of the ABIM Foundation, will publish all the “Choosing Wisely” summaries for patients. The aim is that patients will learn to question physicians about when tests and treatments are needed and when they are not. The critical care measures, along with detailed explanations and supporting references, can be found online at choosingwisely.org.
The list was developed from 59 items nominated by committee members representing internal medicine, surgery and anesthesiology, and critical care nurses. Each item was evaluated on evidence, prevalence, cost, relevance and innovation. Committee members researched and debated the items before creating the final list. Critical care in the United States currently accounts for about 0.66% of gross domestic product; Dr. Halpern cited a figure of roughly $103 billion spent in 2012. These costs are driven primarily by the number of ICU beds nationally. Another major contributing factor to cost is the discretionary practices of physicians and other clinicians.
Dr. Halpern quoted an often-cited sentence from Howard Brody, MD, PhD, who, in 2010, called on all specialty societies to create a ‘Top Five’ list of their commonly ordered tests that have only limited benefit (N Engl J Medd 2010;362:283-285). “Unfortunately, the myth that physicians are innocent bystanders merely watching health care costs zoom out of control cannot be sustained,” he said. To date, more than 50 specialty societies have published “Choosing Wisely” guidelines, including the American Society of Anesthesiologists and the American College of Surgeons. —Christina Frangou Dr. Halpern reported receiving grant support from the Greenwall Foundation, the Otto Haas Charitable Trust, Robert Wood Johnson Foundation and Betty Moore Foundation. He is a paid consultant for the World Bank. Dr. Kahn reported grant funding from the Gordon and Betty Moore Foundation. Dr. Wunsch reported no relevant disclosures.
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Cardiothoracic Anesthesiologist University of Miami We are actively recruiting an academic cardiothoracic anesthesiologist at the Associate Professor/Professor level The candidate should have a proven track record of both clinical and research expertise in cardiothoracic anesthesia. The departmental mission is to provide outstanding clinical care, teach and conduct research, as well as develop our faculty to be the leaders of tomorrow. The candidate must be ABA-certified or equivalent. The candidate must have a strong academic background and demonstrated excellence in research, clinical care and teaching. A cardiac anesthesiology fellowship and transesophageal echocardiography certification are required. The University of Miami is an affirmative action and equal opportunity employer. Candidates are encouraged to apply by submitting a letter of interest explaining their academic aspirations, curriculum vitae and at least three letters of references. Electronic submissions are preferred. Please contact Cynthia Saldarriaga, Department of Anesthesiology, University of Miami, 1611 NW 12th St., C301 Miami, FL 33136. Telephone: (305) 585-8342; csaldarriaga@med.miami.edu.
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The following advertorial has been provided by ETView and is designed to support the advertisement presented on the right.
Virtual Sepsis Unit Aids Early Detection
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“virtual sepsis unit,” constructed from ones and zeros, may help speed the identification of severe sepsis or septic shock in patients outside the ICU, new findings suggest. During a three-month pilot study conducted at Mercy Hospital St. Louis, in Missouri, the telemedicine-based system identified all hospitalized patients who developed the complication, according to the researchers, who presented the findings at the 2014 annual meeting of the Society of Critical Care Medicine (poster 1026). Brian M. Fuller, MD, a sepsis expert who was not involved in the study, called the system “striking in its accuracy and in its ability to promptly detect patients. Electronic screening aids such as this could have a very positive impact, especially given the increasing number of sepsis patients, the abundance of data that clinicians are asked to interpret on a daily basis and the unacceptably high mortality rates for sepsis,” said Dr. Fuller,r assistant professor of anesthesiology and emergency medicine in the Department of Anesthesiology at Washington University School of Medicine, in St. Louis. Sepsis occurs in 1% to 2% of all hospitalizations in the United States and affects at least 750,000 people. The cost of treating a single case of sepsis averages $22,100, and the condition takes a $17 billion toll on the nation’s health care budget each year (Crit Care Med 2001;29:1303-1310). Lead researcher Steven Trottier, MD, a physician in the Department of Critical Care Medicine at Mercy Hospital St. Louis, said the system was designed to overcome a key obstacle to timely detection of sepsis patients. “What makes it difficult to recognize these patients early is that they are located in all parts of the hospital,” Dr. Trottierr said. The Mercy telemedicine program was previously limited to monitoring ICU patients, but the new system provides real-time monitoring of all of the hospital’s patients by an offf site team of “Mercy SafeWatch” nurses and physicians. The system looks for patients meeting two or more risk factors for sepsis, including systemic inflammatory response syndrome, elevated lactic acid levels, hypotension and those with an order for blood cultures. Patients meeting the criteria are placed in the virtual sepsis unit. If they go on to meet predefined criteria for organ failure, the system triggers a severe sepsis alarm. A
Mercy SafeWatch nurse immediately verifies the alarm and then notifies the hospital’s rapid response team. Between January and March 2013, when the program was piloted at Mercy Hospital St. Louis, the electronic system placed 11,650 patients in the virtual sepsis unit. It triggered 3,240 alarms, of which the nurse identified 272 as septic shock or severe sepsis. Physician review found that 24 of these patients did not have severe sepsis or septic shock. No other cases of severe sepsis occurred at the hospital during the pilot period, Dr. Trottierr said.
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.
Q. What are some of the limitations involved when using current airway management products during lung isolation procedures? A. For many lung isolation procedures, placing a single-lumen tube with a bronchial blocker or a double-lumen tube (DLT) requires the use of a bronchoscope to confirm and reconfirm the correct position within the trachea. Bronchoscopes do not provide continuous visualization, and they may even obscure the airway when used with an endotracheal tube (ETT). In addition, intraoperative displacement of the ETT, dislocation of the bronchial blocker or other adverse events may occur unexpectedly and require re-bronchoscopy.
Q. How do VivaSight portfolio products overcome current limitations? A. VivaSight-SL and VivaSight-DL have fully integrated imaging systems that give the anesthesiologist continuous airway visualization and ventilation for accurate placement and constant control. Using VivaSight does not require any modifications to the standard intubation procedure.
Q. What is VivaSight-SL? A. VivaSight-SL is a sterile, single-use airway tube with an integrated high-resolution imaging camera. VivaSight-SL permits continuous, real-time images of tube position and more. Shown to be effective when used with bronchial blockers, VivaSight-SL is the ideal device for guaranteeing endobronchial blocker placement. It can be used to visualize the vocal cords and trachea and to provide continuous observation of the carina. VivaSight-SL provides total airway management control during every phase of thoracic surgical procedures requiring lung isolation.
The combination of telemedicinebasedd monitoring and nurse verification had a positive predictive value of 91.2% in identifying septic shock or severe sepsis (95% confidence interval [CI], 87%-94.1%), the study found. “The approach has a very low falsepositive rate, but it needs work to improve its specificity,” Dr. Trottierr said. “At present, the system cannot distinguish patients with systemic infection from patients with other inflammatory disease states resulting in organ failure, such as patients with acute trauma or severe burn.” Dr. Trottierr noted that his team did not document amount of time spent attending to false alarms and that this would be an important cost–benefit consideration. Dr. Fuller agreed that the system needs refining and should continue to undergo rigorous testing. “It would also be very interesting to have a detailed description of the team’s interventions and to know the clinical outcomes of patients included in this study,” he added. However, he said, the approach is “very interesting and the researchers should be commended.” The telemedicine program will be implemented in 13 other Mercy Hospitals during 2014, Dr. Trottierr said. —David Wild
Q. What is VivaSight-DL? A. VivaSight-DL is the world’s first sterile, single-use, double-lumen airway tube with an integrated high-resolution camera. VivaSight-DL overcomes the placement and positioning challenges of current DLTs.
Q. What are the advantages of continuous visualization? A. With uninterrupted observation of the trachea, carina, the open right bronchi and the blocked left bronchi, VivaSight’s position can be verified easily, overcoming current placement and monitoring limitations and improving the quality of airway management. Continuous visualization also allows for immediate corrective action if displacement of a bronchial blocker occurs during surgical maneuvers. Real-time airway monitoring permits rapid removal of accumulating secretions.
Q. What are some of the advantages of using the VivaSight-SL for bronchial blocker placement and positioning? A. Because VivaSight-SL provides complete airway visualization during lung isolation, it facilitates immediate detection of blocker displacement caused by patient repositioning, enabling the anesthesiologist to prevent complications before they occur. Visualization can be made through surgical suite monitors or VivaSight-compatible monitors.
Q. How does VivaSight manage with secretion accumulation? A. An integrated flushing system allows for rapid and efficient camera lens cleaning in situ. In addition, both VivaSight-SL and VivaSight-DL incorporate a unique coating that reduces the incidence of obscured vision due to fogging or secretions.
Q. What are the advantages of VivaSight products? A. VivaSight products: • Provide continuous visualization and monitoring for accurate positioning and precise placement for airway management in real time • Promote fast intubation and more efficient placement • Enable repositioning of VivaSight-SL or the bronchial blocker throughout the procedure • Allow for detecting and monitoring of accumulating intraoperative secretions • Do not interfere with or compromise patient ventilation
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CONFIDENCE Facilitates fast, efficient intubation
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3%
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SpHb Impact in Higher Blood Loss Surgery2 2.5
Average RBC Units Transfused Per Patient
Frequency of Intraoperative Blood Transfusions
SpHb Impact in Lower Blood Loss Surgery1
1.9 2
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Average RBC Units Reduced Per Patient
1.5
1.0** 1
0.5
0
Standard Care Group
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Randomized controlled trial in 327 orthopedic patients. *p=0.03 vs Standard Care Group
Standard Care Group
SpHb Group
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SpHb monitoring is proven to help clinicians reduce blood transfusion in both lower and higher blood loss surgery, and also helps initiate more timely transfusions when they are truly indicated.
To learn more, visit www.masimo.com/hemoglobin Ehrenfeld JM, et al. American Society of Anesthesiologists. 2010;LB05. 2 Awada WFN et al. Proceeding of the Society for Technology in Anesthesia Annual Meeting, 2013: p 51.
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Caution: Federal law restricts this device to sale by or on the order of a physician.
800-257-3810 | www.masimo.com Š 2014 Masimo. All rights reserved.
PRINTER-FRIENDLY VERSION AVAILABLE AT ANESTHESIOLOGYNEWS.COM
Current Concepts In the Management Of the Difficult Airway Volume 11, Number 1
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 Hospitalâ&#x20AC;&#x201C;Texas Medical Center Houston, Texas Executive Director 2009-Present, Society for Airway Management Dr. Hagberg has received grant support from Ambu, Cadence Pharmaceuticals, and Karl Storz Endoscopy, and is also an unpaid consultant for Ambu.
M
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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place an ET through intubating supraglottic ventilatory devices for visualization of ET placement through the SGA (Table 2A).
RIGID/VIDEO 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
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. 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
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.
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 (Table 4).
ENDOTRACHEAL TUBE GUIDES
SUPRAGLOTTIC VENTILATORY DEVICES
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).
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 5).
Alternative Airway Devices
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).
VIEWING STYLETS Viewing stylets provide a view from the tip of the endotracheal tube. Whereas the view from a video laryngoscope is at the end of the laryngoscope, viewing stylets provide a view from the tip of the ET for steering the ET through the cords. The stylet size for this device allows it to be placed within an ET as an independent instrument, or as an adjunct to video or direct laryngoscopy. In addition, some can be used to
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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 6). Other relatively new devices
can be used to best position patients and maintain an open airway during awake intubation (Table 7). 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. The Airway Mobilescope (MAF; Olympus) is a portable, flexible endoscope with expanded viewing and recording capability, incorporating a monitor, LED light source, battery and recording device in a single unit. A completely disposable system, the aScope (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. 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 6) 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 6). 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. A MRI
Conditional 3.0 Tesla manual jet ventilator (Anesthesia Associates, Inc., AincA) is also now available to enable TTJV in the MRI suite for both planned and emergency procedures (Table 6).
CRICOTHYROTOMY Cricothyrotomy (Table 8), 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 9) 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 costeffective, 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.
56
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 Catheters (Cook Medical)
8, 11, 14, and 19 F Polyethylene designs facilitate exchange of SLT or DLT of ≥ 4.0 mm ID. The DLT versions are extra firm with soft-tips. Colors: Yellow, green; soft-tip is purple.
43, 83, 100
Cook Staged Extubation Set (Cook Medical) (Available outside of USA only)
Soft-tipped marked extubation wire to maintain continuous airway access, wire holder and Tegaderm for securement, soft-tipped Reintubation Catheter, Rapi-Fit adapters to assist in oxygen delivery, if necessary.
This set can facilitate reintroduction of ETs with ID >5 mm.
CoPilot VL Single-Use Bougie (Magaw Medical)
14 Fr polyethylene single-use ET introducer with coudé tip.
60 cm length. For use with ETs ≥6.0 mm ID.
CoPilot VL Rigid Stylet (Magaw Medical)
Reusable CoPilot VL intubation stylet.
For use with ET ≥6.0 mm ID.
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)
Reusable, sterilizable, semirigid stylet that conforms to GlideScope unique blade angulation; provides improved maneuverability in ET placement.
Stylet rod length is 26.6 cm. Accommodates ETs ≥6.0 mm ID.
Introes Pocket Bougie (BOMImed)
Single-use 14 Fr (4.7 mm) malleable ET introducer made from 60 accommodates special blend of Teflon. Packaged in box of 10. 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 Reusable, sterilizable, semirigid stylet with optimal shape (Truphatek International Ltd) memory for indirect intubation procedures.
4 sizes. Accommodates ETs 2.5-3.5, 4.0-5.5, 5.06.5, and 7.0-9.0 mm ID.
Pocket Introducer Single-use 15 Fr Introducer with coudé tip. Color: blue. (VBM Medizintechnik GmbH)
65
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.
60
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.
70
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.
Abbreviation key for all tables is on page 28.
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Suitable for use with ETs 6.5-8.5 mm ID.
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.
The Cook airway exchange catheter is intended for uncomplicated, atraumatic, ET exchange for both single- and double-lumen tubes.
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.
Provides a tool for a more complete extubation strategy, which should be in place for every patient.
Utilizes an atraumatic wire to maintain continuous airway access and a soft-tipped reintubation catheter to facilitate a successful reintubation if required and delivery of oxygen when desired.
Facilitate endotracheal intubation. Designed to shape the ET and facilitate intubation with VL. 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 Ranger video laryngoscopes to facilitate intubations in OR, ED, and emergency settings.
Reusable, durable stainless steel; easy to clean and sterilize in an autoclave.
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.
Facilitates endotracheal intubation.
Folded to only 20 cm, unfolds to 65 cm within seconds, ideal space solution for emergency bags.
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.
Non-disposable 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.
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.
table continues on next page
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Table 1. Endotracheal Tube Guides Name (Manufacturer)
(continued)
Description
Length, cm
VBM Introducer Single-use 15 Fr introducer with coudé tip and hollow for (VBM Medizintechnik GmbH) oxygenation. Color: orange.
65
VBM Tube Exchanger Single-use 11, 14, and 19 Fr tube exchanger that is hollow to (VBM Medizintechnik GmbH) allow oxygenation. Color: blue.
80
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 Adult and children holder. Shapes and guides ET while forwardly illumi- (ETs ≥5 mm). nating the passage. Completely reusable device con- Infant (ETs ≥3 mm). sisting of removable handle with xenon bulb.
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.
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.
Table 2A. Viewing Stylets Name (Manufacturer)
Description
Size
AincA VideoStylet (Anesthesia Associates, Inc.)
Easily malleable, video imaging stylet with built-in ET holder. Shapes and guides ET while forwardly illuminating the passage and providing color image. Completely reusable device consisting of removable VideoStylet and attached rechargeable LCD monitor.
Adult and children (ETs ≥6 mm).
air-Vu Plus Fiber-optic Stylet High-resolution, stainless steel, rigid stylet. Incorporates an (Cookgas LLC; distributed adjustable tube stop and optional oxygen port for oxygen by Mercury Medical) insufflation.
Adult (ETs ≥5.5 mm).
Bonfils Retromolar Intubation Endoscope (KARL STORZ Endoscopy)
3.5 and 5.0 mm OD. ET must be ≥0.5 mm larger to fit.
6
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 DCI to endoscopic camera system. Can be used within the C-MAC system while using the portable monitor of the C-MAC VL with C-CAM camera head.
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Clinical Applications
Special Features
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.
Clinical Applications
Special Features
Although usable for routine blind intubations or additional illumination during laryngoscopy, it is especially useful when the FOB is unavailable (eg, outside locations or ambulances), or when bronchoscopy is difficult to perform (eg, obscured airway or limited head motion allowed).
Can be used alone or with other techniques. System is completely disposable. Intended for single use. Individually packaged in boxes of 3.
Same as Aaron Surch-Lite.
Can be used alone or with other techniques. Handle-mounted xenon light source is always on and keeps stylet tip cold. Uses 2 AA batteries. System is completely reusable and sterilizable.
Although it can be used for routine intubations, it is especially useful in situations in which the FOB is unavailable (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).
Blind technique that can be used alone or with other techniques.
Ideal for difficult intubations, teaching.
Minimizes neck flexion and head hyperextension in trauma cases.
Clinical Applications
Special Features
Although usable for routine intubations or video imaging during laryngoscopy, it is especially useful when the FOB is unavailable (eg, outside locations or ambulances), or when bronchoscopy is difficult to perform (eg, obscured airway or limited head motion allowed). Low price allows for multiple units in all critical locations and reusable nature ensures economy of use.
Provides rapid learning curve due to similarity to standard ET advancement techniques, but with the added benefit of an attached, clear video image of all landmarks forward of the ET tip. Allows for one-handed use with imaging or used in conjunction with a laryngoscope, as desired for physical alignment.
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. table continues on next page
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Table 2A. Viewing Stylets
(continued)
Name (Manufacturer)
Description
Size
Brambrink Intubation Endoscope (KARL STORZ Endoscopy)
High-resolution semi-rigid 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 30000V (Clarus Medical)
Malleable (shapeable) rigid stylet scope with attached LCD screen and adjustable curve shape provides view from end of stylet; USB for recharging lithium ion battery and option to connect to notebook or monitor; red LED for transillumination. Assist with DL/VL or used as independent device. Also malleable to be used through intubating supraglottic ventilatory devices.
5 mm OD. ETs ≥5.5 mm.
Levitan GLS (Clarus Medical)
Portable high-resolution optics from end of stylet, malleable (shapeable) rigid stainless steel 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. Assist with DL/VL like regular stylet or used as independent device. Also malleable to be used through intubating supraglottic ventilatory devices. Optional adapter uses smartphones to transform optics to video.
Adult (ETs ≥5.5 mm ID).
PocketScope (Clarus Medical)
Conveniently sized, easy to clean, and cost-effective (reusable) flexible stylet that has a patented, deflected, non-directable tip. Optional adapter uses smartphones to transform optics to video. Often used to confirm placement and patency of airways.
Adult (ETs ≥4.0 mm ID).
SensaScope (Acutronic Medical Systems AG)
Hybrid S-shaped, semi-rigid 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)
Viewing stylet: High-resolution, stainless steel, malleable (shape- Adult (ETs ≥5.5 mm able) fiber-optic stylet that comes in a preformed hockey-stick ID). Pediatric (ETs shape. Has an adjustable tube stop and integral oxygen port for 2.5-5.0 mm ID). oxygen insufflation. Use to assist with DL/VL like regular stylet or used as independent device. Also malleable to be used through intubating supraglottic ventilatory devices. Optional adapter uses smartphones to transform optics to video.
Table 3. Rigid/Video Laryngoscopes Name (Manufacturer)
Description
Size
Airtraq Avant (Prodol Meditec SA; distributed by Airtraq LLC)
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) and anti-fog heater resists lens clouding. 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 (Prodol Meditec SA; distributed by Airtraq LLC)
The SP model is single-use with all the features of the Avant but fully disposable. Both Airtraq models have an optional snap-on camera, with integrated 2.8” Touch Screen that flips and rotates on 2 axes and can be attached to all Airtraq models. It records and can Wi-Fi connect to iPad/iPhone/PC.
6 color-coded sizes available: regular adult for ET 7.0-8.5 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; nonchanneled blade; and doublelumen endobronchial tubes.
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Clinical Applications
Special Features
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.
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.
Similar to flexible FOB. Can be used alone or as an adjunct to laryngoscopy and is especially useful for those unable to maintain skills with a bronchoscope.
Has the simple form of a standard stylet, plus the advantage of a fiber-optic view and maneuverability of its tip. Portable, rugged, and able to lift tissue. Light source options are light cable, Turbo LED or GreenLine laryngoscope handle with adapter.
Clinical Applications
Special Features
Intended to facilitate intubation in both routine and difficult airway situations. Useful in all cases where ET 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.
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Table 3. Rigid/Video Laryngoscopes (continued) (continued) Name (Manufacturer)
Description
Size
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 semi-rigid). 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, and S-Blade (single-use).
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. Next-generation portable VL with an acutely angled blade and C-shaped channel for a bougie. Rechargeable lithium polymer internal battery provides over 2 hours of continuous use. Built-in anti-fog mechanism. GlideScope Titanium systems are available in reusable or single-use options and feature streamlined, low-profile blade designs and durable, lightweight titanium construction. Built-in anti-fog mechanism.
Same as C-MAC.
CoPilot VL (Magaw Medical)
GlideScope Titanium Video Laryngoscope (Verathon)
Adult sizes 3 and 4.
4 blade designs available in reusable or disposable format: LoPro 3 & 4 angled blades, and Mac-style 3 & 4 blades. Compatible with full line of GlideScope AVL pediatric blades. 6 disposable blades, sizes 0-4. Reusable blades in 4 sizes: GVL 2-5.
GlideScope AVL (Advanced Video Laryngoscope; Verathon)
Portable advanced VL features a digital color monitor and digital camera for DVD clarity. Also includes integrated real-time recording and onboard video tutorial. Anti-fog feature to resist lens fogging. Reusable and single-use options available.
GlideScope Ranger and Ranger Single Use Video Laryngoscopes (Verathon)
Portable video laryngoscope designed for EMS and military Reusable Ranger offers 2 blade paramedics. Compact and rugged. Operational in seconds. sizes, 3 and 4. Ranger Single Use is offered with 6 disposable Stats sizes 0-4.
King Vision Video Laryngoscope (Ambu Inc.)
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.
McGrath MAC (Aircraft Medical Ltd; distributed by Covidien)
Portable VL designed for everyday use in the OR, ICU, and ED. Uses disposable Macintosh shaped blades as well as acutely curved X3 Blade. Durable (drop tested up to 2 m). Screen displays minute-by-minute battery life countdown.
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One size, 2 versions, correlating to size 3 laryngoscope. Channeled blade allows use of 6.0 to 8.0 mm ET and minimum mouth opening of 18 mm. Standard blade requires minimum mouth opening of 13 mm. Blade sizes 2, 3, and 4 and X3.
Clinical Applications
Special Features
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. Same as DCI. Highly portable system for use in all hospital settings.
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.
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. Same as DCI.
More VL options for routine and difficult airways— including new Mac-style blades—provide clinicians with a choice of airway tools for a wide range of patients, clinical settings, and teaching purposes.
DVD-quality airway view enables 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. Ideal for EMS (ground and air), military, ED, ICU, and crash cart settings. Offers same benefits as AVL, GVL.
Facilitates both routine and difficult intubations.
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 extreme cases.
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 semi-rigid) 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 polemounted or inserted into waterproof field bag. No special ETs or stylets needed. Can be used while battery is charging. Lightweight, handheld, and battery-operated device well suited for areas outside the OR. Waterproof.
Patent-pending Bougie Port is 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. Reusable blades and video cable, as well as the singleuse Smart Cable, can be completely immersed in the recommended cleaning solution (IPX8 compliant). Includes anti-fog capability, plus real-time recording, display, and playback features on 6.4-in digital, color GlideScope Video Monitor. 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. 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. 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.
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. table continues on next page
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Table 3. Rigid/Video Laryngoscopes
(continued)
Name (Manufacturer)
Description
Size
McGrath Series 5 Video Laryngoscope (Aircraft Medical Ltd; distributed by LMA North America, a Teleflex Company)
Portable VL 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.
The McGrath Series 5 HLDi is the new “High Level Disinfection Immersible” system that is entirely waterproof.
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. 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 VL 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/ FujiFilm/SonoSite)
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.
Table 4. Indirect Rigid Fiber-Optic Laryngoscopes Name (Manufacturer)
Description
Size
Dörges Emergency Laryngoscope Blade (KARL STORZ Endoscopy)
Developed in Europe as a universal blade that combines features of both the MAC and Miller laryngoscope blades.
One size only for patients >10 kg to adult.
Flexible tip or levering fiber-optic MAC laryngoscope blades are designed with a hinged tip controlled by a lever at the proximal end. Designed to fit standard handles.
Adult sizes 3 and 4. Pediatric size 2.
Modified MAC Blades AincA Flex-Tip Fiber-Optic Laryngoscope Blade (Anesthesia Associates, Inc.) Flipper (Teleflex Medical)
Adult sizes only.
Heine Flex Tip Fiber-Optic Laryngoscope Blade (Heine USA, Ltd.) AincA Macintosh Viewing Prisms (Anesthesia Associates, Inc.)
An optically polished viewing prism for attachment to most Macintosh laryngoscope blades (conventional OR fiberoptic). Effectively repositions the practitioner’s viewpoint to the forward portion of the MAC curve via a 30-degree refraction without inverting the image. Clips to the vertical flange of the MAC to “look around the curve of the blade.”
Sizes 2, 3, and 4 for use on Macintosh laryngoscope blades of sizes 2, 3, and 4.
Rüsch Truview EVO (Truphatek International Ltd; distributed by Teleflex Medical)
Indirect rigid laryngoscope with specially designed 42-degree blade curvature; fits onto all standard endoscopic camera heads. Provides clear, unmagnified view of the glottis. Oxygen channel for demisting, clearing secretions, and insufflation.
Adult, small adult, and infant sizes.
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Clinical Applications
Special Features
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.
Difficult intubation cases where mouth opening and neck extension are limited and stable oxygen saturation levels are critical.
Blades can be linked to STORZ HD or other endoscopic systems.
Similar to C-MAC VL.
Can be used as traditional laryngoscope and converted to video laryngoscope by attachment of monitor.
Intended to facilitate intubation in both routine and difficult airway situations.
VividTrac is inserted more like an oral airway device (or LMA) than a laryngoscope blade. The ET can be preloaded or inserted once visualization is achieved in the VividTrac tube channel.
Clinical Applications
Special Features
Blade is inserted into the oropharynx to the appropriate depth, which correlates with the patientâ&#x20AC;&#x2122;s size.
Has 10-kg and 20-kg markings on the blade.
Controlled manipulation of large or floppy epiglottis. Also useful in patients with a recessed mandible and decreased mouth opening.
A lever controls the tip angle through 70 degrees during intubation to lift the epiglottis, if necessary, to improve laryngeal visualization.
Useful in patients with a recessed mandible and decreased mouth opening.
Allows viewing of the vocal cords even in a patient with an anterior airway position. Also useful during nasal intubation (with impaired view) and for postoperative examination of the larynx.
A built-in clip on each prism allows attachment to any Macintosh-type laryngoscope blade that has a standard thickness vertical flange. Usable on both conventional and fiber-optic type MAC blades. Reusable and sterilizable.
Useful for difficult adult and infant airways, including patients with an anterior airway and limited neck extension.
Rugged, portable, easy to maintain. Depth lines on the blade to guide insertion. Can be used with all fiber-optic laryngoscope handles. Designed to provide indirect laryngoscopy with continuous oxygen insufflation. Infant size features an LED light and rechargeable battery.
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Table 5. Selected Supraglottic Ventilatory Devices Name (Manufacturer)
Description
Size
AES The Guardian CPV (AES, Inc.)
All-silicone laryngeal mask with a vented gastric tube and CPV that constantly monitors cuff pressure.
Adult sizes 3, 4, 5.
AES Ultra (AES, Inc.)
All-silicone laryngeal mask with standard cuff valve.
Adult sizes 3, 4, 5, 6.
AES Ultra Clear (AES, Inc.)
Silicone cuff and PVC tube, laryngeal mask with standard cuff valve.
Adult sizes 3, 4, 5, 6.
AES Ultra Clear CPV (AES, Inc.)
Silicone cuff and PVC tube, laryngeal mask with cuff pilot valve (CPV) that constantly monitors cuff pressures.
Pediatric to adult sizes 1, 1½, 2, 2½, 3, 4, 5, 6.
AES Ultra CPV (AES, Inc.)
All-silicone laryngeal mask with CPV that constantly monitors cuff pressures.
Pediatric to adult sizes 1, 1½, 2, 2½, 3, 4, 5, 6.
AES Ultra EX (AES, Inc.; distributed by Anesthesia Associates, Inc.)
All-silicone, multiple-use laryngeal mask (40 uses).
Pediatric to adult sizes 1, 1½, 2, 2½, 3, 4, 5, 6.
AES Ultra Flex CPV (AES, Inc.)
Wire-reinforced, silicone cuff and tube with CPV that constantly monitors pressure changes in the cuff.
Pediatric to adult sizes 1, 1½, 2, 2½, 3, 4, 5, 6.
AES Ultra Flex EX (AES, Inc.; distributed by Anesthesia Associates, Inc.)
All-silicone, wire-reinforced, multiple-use laryngeal mask (40 uses).
Pediatric to adult sizes 1, 1½, 2, 2½, 3, 4, 5, 6.
air-Q Blocker Disposable Laryngeal Mask (Cookgas LLC; distributed by Mercury Medical)
Combines the features of air-Q Disposable Laryngeal Mask, with an additional soft flexible guide tube located to the right of the breathing tube. This channel provides access to the esophagus with a nasogastric tube or Blocker tube that allows clinicians to vent, suction and further block the esophagus.
Sizes (2.5, 3.5, and 4.5) that can accommodate standard ETs up to 8.5 mm. Also available in kits with syringe and lubricant packet.
air-Q Disposable Laryngeal Mask (Cookgas LLC; distributed by Mercury Medical)
Same features as air-Q Reusable Laryngeal Mask, except disposable.
Sizes (1.0, 1.5, 2.0, 2.5, 3.5, and 4.5) that can accommodate standard ETs up to 8.5 mm.
air-Q Reusable Laryngeal Mask (Cookgas LLC; distributed by Mercury Medical)
Hypercurved intubating laryngeal airway that resists kinking, and removable airway connector. Anterior portion of mask is recessed; a larger mask cavity allows intubation using standard ETs. Air-Q removal after intubation is accomplished by using air-Q reusable removal stylet.
Sizes (2.0, 2.5, 3.5, and 4.5) that can accommodate standard ETs 5.5-8.5 mm.
air-Q SP (Cookgas LLC; distributed by Mercury Medical)
Combines the features of the air-Q disposable and reusable laryngeal masks with the added advantage of a self-pressurizing mask. No inflation line or pilot balloon is needed.
Sizes (1.0, 1.5, 2.0, 2.5, 3.5, 4.5) that can accommodate standard ET tubes up to 8.5 mm.
Ambu AuraFlex (Ambu Inc.)
Disposable wire-reinforced flexible LMA.
Adult and pediatric sizes 2-6.
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Clinical Applications
Special Features
Similar to LMA Supreme, but with built-in CPV to minimize postoperative sore throat. Color indicator bands provide instant feedback regarding pressure changes.
The CPV detects changes caused by temperature, nitrous oxide levels, and movement within the airway, enabling clinician to maintain a recommended cuff pressure of 60 cm H2O. Single use.
Standard all-silicone SGA.
All silicone. Single use.
Combines all-silicone cuff with PVC tube for cost savings.
All-silicone cuff with PVC tube. Single use.
Similar to AES Ultra CPV.
Similar to AES Ultra CPV.
Similar to LMA Classic, but with built-in CPV to minimize postoperative sore throat. Color indicator bands provide instant feedback regarding pressure changes.
The CPV detects changes caused by temperature, nitrous oxide levels, and movement within the airway, enabling clinician to maintain a recommended cuff pressure of 60 cm H2O. Single use.
Reusable, standard SGA.
40 uses.
Wire-reinforced SGA that accommodates repositioning of the head and neck. Color indicator bands provide instant feedback regarding pressure changes.
Single use. The cuff pressure indicator detects changes caused by temperature, nitrous oxide levels, and movement within the airway. The CPV enables the clinician to maintain a recommended cuff pressure of 60 cm H2O.
Reusable, wire-reinforced SGA, designed to accommodate repositioning of the head and neck during surgery.
40 uses.
Enhanced version of the standard air-Q. It is indicated as a primary airway device when an oral endotracheal tube is not necessary or as an aid to intubation in difficult situations.
The soft guide tube allows access to the posterior pharynx and esophagus by supporting and directing medical instruments beneath the air-Q mask and into the pharynx and esophagus. Medical instruments especially suited are suction catheters, nasogastric tubes up to size 18.0 Fr, and the newly designed air-Q Blocker tubes. The Blocker tubes are designed to suction the pharynx, or suction, vent and block the upper esophagus during use of the air-Q Blocker airway. Removable color-coded connector allows intubation with standard ETs up to 8.5 mm.
Same as air-Q Reusable Laryngeal Mask.
Removable color-coded connector allows intubation with standard ETs up to 8.5 mm.
Similar to both LMA Classic and LMA Fastrach. Allows easy access for flexible fiber-optic devices. Use as routine masked laryngeal airway. Removable connector allows intubation with standard ETs up to 8.5 mm.
Designed to minimize folding of the cuff tip on insertion. Same use and benefits as LMA Classic and LMA Fastrach. Integrated bite block reinforces the tube while diminishing the need for a separate bite block. Color-coded removable connectors are tethered to the airway tube, avoiding episodes of misplaced connectors.
Same as regular air-Q but eliminates the need for mask inflation.
PPV self-pressurizes the mask cuff. On exhalation, mask cuff decompresses to the level of PEEP. Removable connector allows intubation with standard ETs.
Designed for use in ENT, ophthalmic, dental, and torso surgeries.
Integrated pilot tube, and high flexibility enables positioning away from the surgical field, without a loss of seal. Single use. EasyGlide texture and extra-soft cuff ease insertion and removal. Convenient depth marks for monitoring correct position of the mask. table continues on next page
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Table 5. Selected Supraglottic Ventilatory Devices
(continued) (continued)
Name (Manufacturer)
Description
Size
Ambu Aura-i (Ambu Inc.)
Laryngeal mask with built-in curve and bite blocker designed as a conduit for optical endotracheal intubation.
Adult and pediatric sizes 1-6.
Ambu AuraOnce (Ambu Inc.)
A laryngeal mask with a special built-in curve that replicates natural human anatomy. It is molded in 1 piece with an integrated inflation line and no epiglottic bars on the anterior surface of the cuff.
Adult and pediatric sizes 1-6.
Ambu AuraStraight (Ambu Inc.)
Similar to the LMA Unique but without epiglottic bars on the anterior surface of the cuff.
Adult and pediatric sizes 1-6.
Ambu Aura40 (Ambu Inc.)
Same design as the Ambu AuraOnce, but reusable.
Adult and pediatric sizes 1-6.
Ambu Aura40 Straight (Ambu Inc.)
Similar to the LMA Classic. No epiglottic bars on the anterior surface of the cuff.
Adult and pediatric sizes 1-6.
CobraPLA (Pulmodyne)
Large ID laryngeal tube, which is soft and flexible with a tapered, striated tip. Now has an improved distal curve, softer tube, and softer head. It has a highvolume, low-pressure oropharyngeal cuff.
Adult and pediatric sizes ½-6.
CobraPLUS (Pulmodyne)
Similar to the CobraPLA. Includes temperature monitor and distal gas sampling in all sizes.
Adult and pediatric sizes ½-6.
Esophageal Tracheal Combitube (Covidien)
A disposable DLT that combines the features of a conventional ET with those of an esophageal obturator airway. Has a large proximal latex oropharyngeal balloon and a distal esophageal low-pressure cuff with 8 ventilatory holes in between.
Two adult sizes. 41 Fr: height >5 ft. 37 Fr: height 4-6 ft.
i-gel (Intersurgical Inc.)
SGA with a noninflating cuff, designed to mirror the anatomy over the laryngeal inlet, with an integral bite block, buccal cavity stabilizer and a gastric channel. It also incorporates a wide-bore airway channel that can be used as a conduit for intubation with fiberoptic guidance (sizes 3, 4, and 5).
Adult sizes 3-5 and pediatric sizes 1-2.5. Adult sizes accommodate ET sizes 6.0-8.0 mm.
i-gel O2 Resus Pack (Intersurgical Inc.)
SGA with a supplementary oxygen port, an integral Adult sizes 3-5. color-coded hook ring for securing of the airway sup- Adult sizes accommodate ET port strap and identification of size and is designed sizes 6.0–8.0 mm. to facilitate ventilation. It also includes a non-inflating cuff to mirror the anatomy, with an integral bite block, buccal cavity stabilizer and a gastric channel. The pack contains an i-gel O2 second-generation SGA, a sachet of lubricant and an airway support strap.
KING LT (Ambu Inc.)
Multiuse, latex-free, single-lumen silicone tube with oropharyngeal and esophageal low-pressure cuffs, 2 ventilation outlets, insertion marks, and a blind distal tip (almost like a single-lumen, shortened Combitube). Color-coded connectors for each size.
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Sizes 0-5.
Clinical Applications
Special Features
Combines everyday routine use of SGA with direct intubation capability in case of difficult airway situations.
Anatomically correct curve designed as Ambu AuraOnce and Ambu Aura40 but specially designed as a conduit for intubation. Compatible with standard ETs.
Allows easy access for flexible fiber-optic devices. For use in both anesthesia and emergency medicine.
Anatomically correct curve facilitates placement. One-piece mold. EasyGlide texture for ease of insertion. Convenient depth marks for monitoring correct position of the mask. MRI safe. Extra-soft cuff. If intubation becomes necessary or desired, recommend intubation over Aintree AEC. -Single use.
For use in both anesthesia and emergency medicine.
Single-use, one-piece mold. EasyGlide texture for ease of insertion. Convenient depth marks for monitoring correct position of the mask. MRI safe. Extra-soft cuff.
Same as LMA Classic.
Same as LMA Classic, but reusable.
Same as LMA Classic.
Reusable. Available only in the United States.
Same as LMA Classic.
Disposable. If intubation becomes necessary or desired, will accommodate ET up to 8.0 mm. Single use.
Same as LMA Classic. An added benefit is the ability to measure core temperature. In addition, distal CO2 can be monitored in pediatric patients.
Similar to CobraPLA, but CobraPLUS allows monitoring of the patientâ&#x20AC;&#x2122;s core temperature. In neonatal and infant patients, CobraPLUS has the ability to increase the accuracy of end-tidal CO2 and volatile gas analysis. If intubation becomes necessary or desired, will accommodate ET up to 8.0 mm. Single use.
Same as LMA Classic but not contraindicated in nonfasting patients. Appropriate for prehospital, intraoperative, and emergency use. Especially useful for patients in whom direct visualization of the vocal cords is not possible, patients with massive airway bleeding or regurgitation, limited access to the airway, and patients in whom neck movement is contraindicated.
Ventilation is possible with either tracheal or esophageal intubation. Distal cuff seals off the esophagus to prevent aspiration of gastric contents. Allows passage of an orogastric tube when placed in the esophagus. Single use.
Indicated for use in routine and emergency anesthesia and resuscitation in adult patients. i-gel is not indicated for use in resuscitation in children. Can be used as a conduit for intubation with fiber-optic guidance (sizes 3, 4, and 5). Gastric channel provides an early warning of regurgitation, allows for the passing of a nasogastric tube to empty the stomach contents and can facilitate venting of gas from the stomach (except size 1).
The non-inflating cuff allows easy and rapid insertion, provides high seal pressures and minimizes the risk for tissue compression. Gastric channel provides an early warning of regurgitation. Buccal cavity stabilizer reduces the risk for rotation or displacement and the integral bite block prevents occlusion of the airway channel. The wide-bore airway channel also allows for use as a conduit for intubation with fiber-optic guidance (sizes 3, 4, and 5).
Indicated for use in routine and emergency anesthesia and resuscitation in adult patients. Can be used as a conduit for intubation with fiber-optic guidance. i-gel O2 can also be used for providing supplementary oxygen during postoperative care or patient transfer. Gastric channel provides an early warning of regurgitation, allows for the passing of a nasogastric tube to empty the stomach contents and can facilitate venting of gas from the stomach.
The non-inflating cuff allows easy and rapid insertion, provides high seal pressure and minimizes the risk for tissue compression. The supplementary oxygen port allows for the administration of passive oxygenation as a component of cardio-cerebral resuscitation. Gastric channel provides an early warning of regurgitation. Buccal cavity stabilizer reduces the risk for rotation or displacement and the integral bite block prevents occlusion of the airway channel. The wide-bore airway channel also allows for use as a conduit for intubation with fiber-optic guidance.
Same as LMA Classic, but with ventilatory seal characteristics like those of LMA ProSeal.
Easily inserted, possible aspiration protection, and allows both PPV and spontaneous breathing. Reusable (up to 50 times).
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Table 5. Selected Supraglottic Ventilatory Devices
(continued) (continued)
Name (Manufacturer)
Description
Size
KING LT-D (Ambu Inc.)
Same design as the KING LT, except disposable.
Adult sizes 3-5 and pediatric sizes 2, 2.5.
KING LTS (Ambu Inc.)
Double-lumen laryngeal tube that incorporates a second (esophageal) lumen posterior to the ventilation lumen.
Adult sizes 3-5 and pediatric sizes 0, 1, 2, 2.5.
KING LTS-D (Ambu Inc.)
Same as KING LTS, except disposable.
Adult sizes 3-5.
LMA Classic (LMA North America, a Teleflex Company)
Supraglottic ventilatory device that consists of an oval inflatable silicone cuff in continuity with a widebore tube that can be connected to an Ambu bag or anesthesia circuit. Designed to fit the pharynx of patients of various weights.
Adult and pediatric sizes 1-6, accommodating ET 3.5-7.0 mm.
LMA Classic Excel (LMA North America, a Teleflex Company)
The Classic Excel has the benefits of LMA Classic and an improved design to facilitate intubation.
Adult and pediatric sizes 3-5.
LMA Fastrach (LMA North America, a Teleflex Company)
Consists of a mask attached to a rigid stainless steel tube curved to align the barrel aperture to the glottic vestibule. The set includes an LMA with a stainless steel shaft covered with silicone (reusable version) and a single movable epiglottic elevating bar, ET stabilizer, and silicone wire-reinforced ET. The single-use Fastrach is made of PVC and includes a disposable wire-reinforced ET.
Adult sizes 3-5 that can accommodate special ETs 6.0-8.0 mm.
LMA Flexible (LMA North America, a Teleflex Company)
Original LMA cuff design attached to smaller diameter, flexible armored tube that allows repositioning of the tube without cuff displacement. New single-use version is easier to insert.
Adult and pediatric sizes 2-6.
LMA ProSeal (LMA North America, a Teleflex Company)
Designed with a modified cuff and dual tubes to separate the respiratory and alimentary tracts. Has a built-in bite block.
Adult and pediatric sizes 1-5.
LMA Supreme (LMA North America, a Teleflex Company)
Has a gastric drain tube designed to suction the stomach, channel gases and fluids away from the airway, and confirm placement of the tip of mask at upper esophageal sphincter. The airway tube has a gentle curve and oblong shape to allow easier insertion and more stable placement.
Adult and pediatric sizes 1-5.
LMA Unique (LMA North America, a Teleflex Company)
Original, disposable LMA design. Sterile, latex-free, available with or without syringe and lubricant. Soft cuff and airway tube allow for conformity to patients’ natural anatomy.
Adult and pediatric sizes 1-5.
Rüsch Easy Tube (Teleflex Medical)
Disposable LT that combines the features of a conventional ET with those of an esophageal obturator airway similar in design to the Combitube.
Small 28 Fr; large 41 Fr.
Soft-Seal Laryngeal Mask (Smiths Medical)
Similar in shape to the LMA Unique, but differs in its 1-piece design, in which the cuff is softer and there is no “step” between the tube and the cuff, an integrated inflation line, no epiglottic bars on the anterior surface of the cuff, and a wider ventilation orifice.
Adult and pediatric sizes 1-5.
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Clinical Applications
Special Features
Same as KING LT.
Also available in a kit. Single use.
Same as KING LT, except that it has a second lumen for gastric access, similar to LMA ProSeal.
Allows easy passage of a gastric tube to evacuate stomach contents. Distal tip reduced in size to facilitate insertion. Reusable.
Same as KING LTS.
Allows passage of 18 Fr gastric tube. Also available in a kit.
Although originally developed for airway management of routine cases with spontaneous ventilation, it is now listed in the ASA Difficult Airway Algorithm as an airway ventilatory device or a conduit for endotracheal intubation. Can be used in both pediatric and adult patients in whom ventilation with a face mask or intubation is difficult or impossible. Can also be used as a bridge to extubation and with pressure support or PPV.
Reusable.
Same as LMA Classic.
Removable connector and epiglottic elevating bar to facilitate intubation. Works with ET up to 7.5 mm. Reusable up to 60 times.
Useful for ventilation and intubation. Designed for blind orotracheal intubation but can be used with lighted stylets, FOB, or Flexible Airway Scope Tool. FOB recommended when using PVC ET.
Both reusable and disposable versions now available. Can be utilized as a blind or visually guided technique. Benefits include ability to intubate with larger ET and remove the device easily over the ET.
Particularly useful in ENT/head and neck procedures.
Both reusable and disposable versions now available. Airway tube resists kinking and cuff dislodgment, and thus may be positioned away from the surgical field without loss of seal.
Same as LMA Classic except drain tube also allows for evacuation of stomach contents.
Second cuff allows tighter seal for PPV. Reusable.
Same as LMA ProSeal.
A single-use LMA with a redesigned mask that achieves a 50% higher seal pressure than the Classic or Unique. Similar to all LMAs, the Supreme is designed to protect the airway from epiglottic obstructionâ&#x20AC;&#x201D;in this model with molded fins in the bowl of the mask.
Same as LMA Classic. Included in AHA 2000 Guidelines for CPR and Emergency Medicine Cardiovascular Care.
Single use.
Same as Esophageal Tracheal Combitube.
Similar to Combitube with following differences: single lumen at distal tip, soft latex-free cuff, open proximal second lumen allows use of fiber-optic device or passage of a suction catheter or tube exchanger. Single use.
Same as LMA Classic. Allows easy access for flexible fiber-optic devices.
If intubation becomes necessary or desired, will accommodate ET up to 7.5 mm. Single use.
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Table 5. Selected Supraglottic Ventilatory Devices
(continued)
Name (Manufacturer)
Description
Size
Solus Satin Laryngeal Mask Airway (Intersurgical Inc.)
A range of single-use, latex-free laryngeal mask airways with a softer airway tube to provide more flexibility.
Adult sizes 3-5.
Solus Standard Laryngeal Mask Airway (Intersurgical Inc.)
A range of single-use, latex-free laryngeal mask airways.
Adult sizes 3-5 and pediatric sizes 1-2.5.
Table 6. Devices for Special Airway Techniques Name (Manufacturer)
Description
Size
Awake Intubation DeVilbiss Model 15 Medical Atomizer (DeVilbiss Healthcare)
Metal atomizer; includes glass receptacle (for liquid), Length: 10.5 in. pair of metal outlet tubes extending from metal atomizing nozzle, and adjustable tip for directing spray to inaccessible areas of the throat. Can be used with or without RhinoGuard tip cover.
Enk Fiberoptic Atomizer Set (Cook Medical)
Device for atomizing small doses of local anesthetics. Atomizer set consists of a pressure-resistant oxygen tube and a connecting tube attached by a 3-way sidearm fitting with a small flow control opening. The set also contains an introducer catheter and 2 syringes (1-mL).
EZ-Spray (Alcove Medical)
Disposable atomizer device which comprises a plastic receptacle, atomizer nozzle, and gas inlet tube. Tubing is connected from an air or oxygen flowmeter nipple to the gas inlet tube on the device.
LMA MADdy Pediatric Mucosal Atomization Device (LMA North America, a Teleflex Company)
Pediatric Mucosal Atomization Device delivers intranasal/intraoral medications in a fine mist that enhances absorption and improves bioavailability for fast and effective drug delivery.
LMA MADgicWand Mucosal Atomization Device (LMA North America, a Teleflex Company)
Combines atomized topical anesthesia and oxygen Typical particle size: delivery in a fiber-optic oral airway. Packaged in a box 30-100 microns. of 20. System dead space: 0.25 mL.
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Typical particle size: 30 microns. System dead space: 0.12 mL (with syringe), 0.07 mL (device only). Tip diameter: 0.19 in (4.8 mm). Applicator length: 4.5 in (11.4 cm).
Clinical Applications
Special Features
Indicated for use in anesthesia and emergency medicine. Single-use laryngeal mask airway, provided sterile and ready for use.
Classic cuff shape for optimum anatomic conformance with a firm, smooth-surfaced back plate to aid ease of insertion. The Satin Solus has a softer airway tube to provide more flexibility. Clear, pliable airway tube allows for early detection of rising fluids. Cuff size indicators are accurately aligned and prominently displayed at top of tube and on pilot balloon. Essential user information on exposed section of airway tube for quick visual reference.
Indicated for use in anesthesia and emergency medicine. Single-use laryngeal mask airway, provided sterile and ready for use.
Classic cuff shape for optimum anatomic conformance with a firm, smooth-surfaced back plate to aid ease of insertion. Clear, pliable airway tube allows for early detection of rising fluids. Cuff size indicators are accurately aligned and prominently displayed at top of tube and on pilot balloon. Essential user information on exposed section of airway tube for quick visual reference.
Clinical Applications
Special Features
Intended for the application of topical anesthetics to the nose, oropharynx, and upper airway of patients, at the direction/discretion of a clinician.
Includes glass receptacle for dispensing the liquid; adjustable swivel top and vented nasal guard attached to a hand bulb. Can be used with all types of oil or water solutions that are compatible with rhodium metal plating. The allmetal top can be autoclaved. Reusable.
To apply topical anesthetics to laryngotracheal area through the working channel of a bronchoscope using oxygen flow. Designed and intended to be used by those trained and experienced in techniques of flexible fiber-optic intubation.
Device is an accessory to a bronchoscope. Delivery form is a fine spray mist using oxygen flow through the working channel bronchoscope. Sterile. Single use.
Application of topical anesthetic to the nose, oropharynx, and upper airway of patients, at the direction/discretion of a clinician.
Trigger-valve system provides controlled release of compressed gas to an atomizing nozzle, creating a liquid spray. Gas flow is adjusted to the desired setting. Use with either oil- or water-based solutions. Nonsterile. Single use.
Application of topical anesthetics to oropharynx and upper airway region. Fits through vocal cords, down LMA, or into nasal cavity.
Child-friendly and no sharps (bright colors in a toy-like presentation make the procedure less scary for young patients). Flexible (internal stylet provides support, malleability and memory). Disposable (single patient use, eliminates risk for cross-contamination). Practitioner-controlled (patient needs targeted specially by medication, concentration, position, and location).
Allows retraction of soft tissue while applying topical anesthesia in a fine, gentle mist. Used to apply topical anesthetic to the airway before awake intubation.
Device blade positioned along floor of the mouth can be directed immediately in front of laryngeal inlet to generate a fine mist by a piston syringe. Nonsterile. Single use.
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Table 6. Devices for Special Airway Techniques
(continued) (continued)
Name (Manufacturer)
Description
Size
LMA MADgic Laryngo-Tracheal Atomizer (LMA North America, a Teleflex Company)
Mucosal atomization device that incorporates a small flexible, malleable tube with an internal stiffening stylet that connects to a 3-mL syringe.
Typical particle size: 30-100 microns. System dead space: 0.25 and 0.13 mL. Tip diameter: 0.18 in (4.6 mm). Applicator length: 8.5 in (21.6 cm) and 4.5 in (11.4 cm).
LMA MAD Nasal-Intranasal Mucosal Atomization Device (LMA North America, a Teleflex Company)
Disposable, compact atomizer for delivery of medications to the nose and throat in a fine, gentle mist.
Typical particle size: 30-100 microns. System dead space: 0.13 and 0.07 mL. Tip diameter: 0.17 in (4.3 mm). Applicator length: 1.65 in (4.2 cm).
Available as a complete set in 6.0, 11.0, or 14.0 F. 14 F version includes Airway Exchange Catheter with RapiFit adapters to allow for delivery of oxygen.
6.0 F=50 cm; 14.0 F=60 cm, extra stiff floppy tipped guide wire = 110 cm.
Open CPAP with an integral pressure-relief system. The CPAP device has 2 ports: a green one with integral oxygen connecting tube, and a colorless port for controlling pressure, monitoring CO2, and adding oxygen.
Small, small adult, medium adult, and large adult.
Retrograde Cook Retrograde Intubation Set (Cook Medical)
Face Mask Ventilation Boussignac CPAP System (LMA North America, a Teleflex Company)
Endoscopy Mask Face mask with diaphragm to allow simultaneous ven- Newborn, infant, child, and (VBM Medizintechnik GmbH) tilation and endoscopy. adult.
Transtracheal Jet Ventilation AincA Manual Jet Ventilator (Anesthesia Associates, Inc.)
Portable jet ventilation device with thumb depression mechanism that initiates a controlled burst of oxygen flow. Customizable assembly includes DISS inlet connection, 5 ft of inlet tubing, flow control knob, on/off thumb control, internal filter, back pressure gauge, and 2 ft of outlet hose ending in a Luer-Lok male fitting. Connects to any tool or port that has a LuerLok female connection (ie, malleable stylets, various adapters, etc).
Jet ventilation catheters of malleable copper with Luer fittings accommodate adults, children, and infants. Adapters allow direct connection to bronchoscope or ET.
AincA MRI Conditional 3.0 Tesla Manual Jet Ventilator (Anesthesia Associates, Inc.)
Similar to AincA Manual Jet Ventilator but certified MRI Conditional窶田ompatible for use in units up to 3.0 Tesla strength.
Jet ventilation catheters of malleable copper with Luer fittings accommodate adults, children, and infants. MRI Conditional 3.0 Tesla.
Enk Oxygen Flow Modulator Set (Cook Medical)
Complete set including 15-gauge needle with reinforced fluorinated ethylene propylene catheter, syringe (5 cc), connecting tubing, and Enk oxygen flow modulator with tracheal catheter connector.
7.5 cm (2.0 mm ID).
Manual Jet Ventilator (Instrumentation Industries)
Complete set includes an on/off valve, 6 ft of highpressure tubing, and 4 ft of small-bore tubing.
Jet ventilation catheter size 13G can accommodate adults, and 14G children.
Manujet III Complete set including 13 ft high-pressure hose (VBM Medizintechnik GmbH) assembly with oxygen DISS fittings, 40-degree small bore tube assembly (with luer lock fitting) and 3 jet ventilation catheters (13G, 14G, and 16G).
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Jet ventilation catheters can accommodate adults, children, and infants.
Clinical Applications
Special Features
Application of topical anesthetics to oropharynx and upper airway region. Fits through vocal cords, down LMA, or into nasal cavity.
Malleable applicator retains memory to adapt to individual patient’s anatomy. Delivery of a fine spray mist is generated by a piston syringe. Luer connection adapts to any luer lock syringe. Nonsterile. Single use.
Intranasal medication delivery offers a rapidly effective method to deliver selected medications to a patient without the need for a painful shot and without the delays in onset seen with oral medications.
Rapidly effective (atomized nasal medications absorb directly into blood stream, avoiding first-pass metabolism; atomized nasal medications absorb directly into the brain and cerebrospinal fluid via olfactory mucosa to nose–brain pathway, achieves medication levels comparable to injections). Controlled administration (exact dosing, exact volume, titratable to effect [repeat if needed], atomizes in any position, atomized particles are optimal size for deposition across broad area of mucosa).
Technique used for securing a difficult airway, either alone or with other alternative airway techniques. Especially useful in patients with limited neck mobility or patients who have suffered airway trauma. 6.0 Fr places tubes ≥2.5 mm ID; 14.0 Fr places tubes ≥5.0 mm ID.
Packaged as a complete kit with everything needed to perform a retrograde intubation. The recently added Arndt Airway Exchange Catheter allows for patient oxygenation and facilitates placement of an ET. Disposable.
Provides respiratory assistance to patients breathing spontaneously. Effective postoperatively in obese patients with sleep apnea.
Compatible with all face masks, ETs, and tracheostomy tubes. Mask head harness is designed for patient comfort.
• Fiber-optic intubation • Airway endoscopy • Gastroenterology • Transesophageal echocardiography
Available in different sizes and with different sizes of diaphragms for a perfect seal during endoscopy. Special Bronchoscope Airway available to protect equipment and aid endoscopy.
Manual Jet Ventilation for oxygen saturation maintenance and usable for emergency direct TTJV and for laser throat surgery (elimination of plastic ET in laser path).
Easy factory customization available for hose lengths and oxygen source connection type (DISS vs various quickdisconnect types) as well as optional pressure regulator (with gauge) and standard or custom regulator-to-source connection hoses. Adapters, fittings, and connectors available. Completely reusable and sterilizable.
Similar to the AincA Manual Jet Ventilator, but fully certified for use in MRI suites with coil strength to 3.0 Tesla. Allows emergency oxygen saturation maintenance while determining how to solve airway issues.
Easy factory customization available for hose lengths and oxygen source connection type (DISS vs various quickdisconnect types). Adapters, fittings, and connectors available. Completely reusable and sterilizable.
Similar to the AincA Manual Jet Ventilator. RecomPackaged as a complete set with everything needed to permended for use when jet ventilation is appropriate but a form TTJV. Disposable. jet ventilator is unavailable. Same as Manujet III. Can also be used in unobstructed difficult airway management.
Offered with and without an adjustable pressure regulator. Partially reusable outlet tube is disposable. NOTE: Outlet tube is single-use.
Well-accepted method for securing ventilation in rigid and interventional bronchoscopy. Because airflow is generally unidirectional, it is important that air has a route to escape (unobstructed airway).
Packaged as a complete kit with jet ventilation catheters to perform TTJV. Includes gauge and regulator.
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Table 7. Positioning Devices Name (Manufacturer)
Description
Chin-UP (Dupaco Inc.; distributed by Mercury Medical)
Hands-free airway support device used to lift up the patientâ&#x20AC;&#x2122;s chin and hold it in position to keep the airway open.
Face-Cradle (Mercury Medical)
Fully adjustable cushion set accommodates most adult head sizes.
JED Jaw Elevation Device (Hypnoz Therapeutic Devices; distributed by LMA North America, Inc., a Teleflex Company)
Hands-free, noninvasive device that helps clinicians maintain an open airway during any procedure in which a patient is sedated and the airway may be compromised.
RAMP Rapid Airway Management Positioner (Airpal Patient Transfer Systems, Inc.)
Air-assisted medical device that can be inflated to transfer and position patients for various procedures.
Troop Elevation Pillow (Mercury Medical)
Foam positioning device that quickly achieves the headelevated laryngoscopy position (HELP). Includes many accessories (head cradle, arm board pads, additional pillow).
Table 8. Cricothyrotomy Devices Name (Manufacturer)
Description
Size
Needle Cricothyrotomy Emergency Transtracheal Air- 6 Fr reinforced fluorinated ethylene propylene way Catheter (Cook Medical) catheter.
5.0 and 7.5 cm.
Percutaneous Cricothyrotomy Melker Emergency Cricothyrotomy Catheter Set (Cook Medical)
Complete set including syringe (10 cc), 2- to 18-gauge introducer needles with TFE catheter (short and long), 0.038-in diameter Amplatz extra-stiff guidewire with flexible tip, scalpel, curved dilator with radiopaque stripe, and PVC airway catheter. Also available in a Special Operations kit, which includes all of the above in a slip peel-pouch and 2 airway catheters.
Standard kit: 3.8 cm (3.5 mm ID), 4.2 cm (4.0 mm ID), and 7.5 cm (6.0 mm ID). Special kit: 4.2 and 7.5 cm.
Pertrach Emergency Cricothyrotomy Kit (Pulmodyne)
Contents include 2 splitting needles, cuffed or uncuffed Trach tube, dilator with flexible leader, twill tape, syringe, extension tube, and scalpel (optional).
Adult: 6.8 cm (5.6 mm ID). Child: 3.9 cm (3.0 mm ID), 4.0 cm (3.5 mm ID), 4.1 cm (4.0 mm ID), and 4.4 cm (5.0 mm ID).
Quicktrach Emergency Complete kit includes airway catheter, stopper, needle, Cricothyrotomy Device and syringes that come preassembled. (VBM Medizintechnik GmbH)
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Adult (4.0 mm ID) and child (2.0 mm ID).
Clinical Applications
Special Features
Aids during monitored anesthesia care and total intravenous anesthesia sedation procedures.
Disposable polyurethane foam cushions.
For use in prone-position surgeries. OR procedures, MRI, recovery, FOB intubation, and interventional radiology, oral surgery, and endoscopy procedures.
Assists provider in maintaining an open airway in sedated or anesthetized patients without the need for additional instrumentation. Frees medical personnel from the need to hold the jaw manually in sedated patients. When left in place after a procedure, reduces postoperative airway complications. Noninvasive and easy to use. Reusable device with disposable pads.
Allows for the positioning of a patient for direct laryngoscopy, extubation, and central venous access. Enhances the safe apnea period, bag valve mask ventilation, and chest wall excursion.
Base of the RAMP is integrated with an Airpal platform (air-assisted lateral patient transfer and positioning device). Inflates and deflates, thus can remain in place during surgery and reinflate for extubation. Reusable.
Aids airway management for obese patients by aligning upper airway axes, and facilitating mask ventilation, laryngoscopy, direct laryngoscopy, and central venous access. Allows patients to breathe more comfortably during preoxygenation and regional anesthesia.
Available in disposable and reusable formats. Troop Elevation Pillow may be added for super morbidly obese patients.
Clinical Applications
Special Features
A lifesaving procedure that is the final option for “cannotventilate, cannot-intubate” patients in all airway algorithms.
Designed to be kink-resistant specifically for the purpose of needle cricothyrotomy.
Same as Emergency Transtracheal Airway Catheter. Intended to be used with the Seldinger technique via the cricothyroid membrane; however, it has the capability to be used as a surgical cricothyrotomy.
Packaged as a complete kit with everything needed to perform a percutaneous cricothyrotomy. The Special Operations kit comes in a slip peel-pouch for easy transport to offsite locations. Also can be used in the OR. It comes with 2 differently sized airway catheters to reduce the number of kits needed in the field. Disposable.
Use in failed orotracheal or nasotracheal intubation and/ or fiber-optic bronchoscopy. Immediate airway control in patients with maxillofacial, cervical spine, head, neck, and multiple trauma. Also used when endotracheal intubation is impossible and/or contraindicated. Immediate relief of upper airway block.
Serves as an emergency cricothyrotomy or tracheostomy device that uses a patented splitting needle and dilator to perform a rapid and simple procedure.
Same as Melker Emergency Cricothyrotomy Catheter Set.
Packaged as a complete kit with everything needed to perform a percutaneous cricothyrotomy—even the neck tape and connecting tube. The removable stopper is used to prevent a “too-deep” insertion and avoid the possibility of perforating the rear tracheal wall. The conical needle tip allows for the smallest necessary stoma and reduces the risk for bleeding. Easily transported to offsite locations. Disposable. table continues on next page
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Table 8. Cricothyrotomy Devices Name (Manufacturer)
(continued)
Description
Size
Melker Surgical Cricothyrotomy Set (Cook Medical)
Cuffed cricothyrotomy tube, scalpel, tracheal hook Trousseau dilator, and blunt curved dilator in compact package for convenient storage.
9.0 cm (5 mm ID).
Melker Universal Emergency Cricothyrotomy Catheter Set (Cook Medical)
Same as Melker Cuffed Emergency Cricothyrotomy Catheter Set for percutaneous technique. Also includes for surgical technique: tracheal hook, safety scalpel, Trousseau dilator, and blunt curved dilator.
9.0 cm (5.0 mm ID).
Surgical Cricothyrotomy
Surgicric 1 Surgical cricothyrotomy. (VBM Medizintechnik GmbH)
7.0 mm ID.
Table 9. Tracheostomy Devices Name (Manufacturer)
Description
Size
Percutaneous Dilatational Tracheostomy Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer (Cook Medical)
Complete kit with size-specific Blue Dolphin balloon dilator. Available with or without Shiley 6 or 8 PERC tracheostomy tubes. A tray version is available that includes lidocaine/epinephrine, 15-mm swivel connector, chlorhexidine skin prep, drape, and suture.
21, 24, 26, 27, 28, 30 Fr introducers.
Ciaglia Blue Rhino Percutaneous Introducer Set (Cook Medical)
Complete kit includes 24.0, 26.0, and 28.0 Fr loading dilators and Shiley 6 or 8 PERC disposable dual-cannula tracheostomy tube. A tray version is available that includes lidocaine/ epinephrine, connector, chlorhexidine skin prep, drape, needle driver, and suture.
74 mm (6.4 mm ID); 79 mm (7.6 mm ID).
Portex Ultraperc Percutaneous Dilatational Tracheostomy Kit (Smiths Medical)
Complete set with or without a tracheostomy tube.
70.0 mm (7.0 mm ID); 5.5 mm (8.0 mm ID); 81.0 mm (9.0 mm ID).
Weinmann Tracheostomy Exchange Set (Cook Medical)
Includes Cook Airway Exchange Catheter, Tracheostomy loading dilators, and a Blue Rhino dilator for re-dilation if necessary.
For use with tracheostomy tubes as follows: 74 mm (6.4 mm ID); 79 mm (7.6 mm ID).
Shiley TracheoSoft XLT Extended-Length Tracheostomy Tubes (Covidien)
Available in 4 ISO sizes (5.0, 6.0, 7.0, and 8.0 mm ID). Each size offers the choice of cuffed or uncuffed stylets, and proximal or distal extensions. Disposable inner cannula; replacements sold in packages of 10.
90 mm (5.0 mm ID); 95 mm (6.0 mm ID); 100 mm (7.0 mm ID); 105 mm (8.0 mm ID).
Surgical Tracheostomy Surgical tracheostomies are performed by making a curvilinear skin incision along relaxed skin tension lines between sternal notch and cricoid cartilage. A midline vertical incision is then made dividing strap muscles, and division of thyroid isthmus between ligatures is performed. Next, a cricoid hook is used to elevate the cricoid. An inferior-based flap or Bjork flap (through second and third tracheal rings) is commonly used. The flap is then sutured to the inferior skin margin. Alternatives include a vertical tracheal incision (pediatric) or excision of an ellipse of anterior tracheal wall. Finally, the tracheostomy tube is inserted, the cuff is inflated, and it is secured with tape around the neck or stay sutures.
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Clinical Applications
Special Features
This set provides the tools that clinicians can use if they prefer a surgical approach to performing emergency cricothyrotomy.
Complete and convenient packaging.
Same as Melker Emergency Cricothyrotomy Catheter Set.
One-half of the tray is the same as Melker Cuffed Emergency Cricothyrotomy Catheter Set for the percutaneous technique. The other half of the tray includes all items needed to perform a surgical emergency cricothyrotomy.
Surgical cricothyrotomy according to the Rapid Four-Step Technique. A lifesaving procedure that is the final option for “cannot-ventilate, cannot-intubate” situations.
Complete kit including scalpel, tracheal hook, dilator, cuffed tracheal tube, fixation and extension tubing.
Clinical Applications
Special Features
One-step dilation and tracheal tube insertion. Establishes transcutaneous access to the trachea below the level of the cricoid cartilage by Seldinger technique.
Unique balloon-tipped design dilatation and tracheal tube insertion in one step. Packaged as a complete kit with everything needed to perform a percutaneous dilatational tracheostomy.
Same as Portex Ultraperc Percutaneous Dilatational Tracheostomy Kit.
Packaged as a complete kit with everything needed to perform a percutaneous dilatational tracheostomy. The single dilator with a hydrophilic coating and flexible tip results in a simpler, less traumatic insertion. The wire guide has a SafeT-J tip to reduce trauma. Disposable.
Establishes transcutaneous access to the trachea below the level of cricoid cartilage. Allows for smooth insertion of the tracheostomy tube over a Seldinger wire.
Packaged as a complete kit with everything needed to perform a percutaneous dilatational tracheostomy. The dilator is single-staged and prelubricated with an ergonomic handle to facilitate insertion. Disposable.
This set is used to facilitate exchange of adult tracheostomy tubes allowing for stomal redilation if required.
This is the only device available that provides an airway exchange catheter to maintain stomal access and that also allows redilation of stoma if resistance is met.
Flexible dual cannula tube for patients with unusual anatomy. Proximal length extension for thick necks; distal length extension for long necks, tracheal stenosis, or malacia.
The only fixed-flange extended-length tube with disposable inner cannula. Flexible inner cannula conforms to the shape of the outer cannula. Sixteen configurations to fit a wide variety of patients. Disposable.
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Recommended Reading 1.
American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2003;98(5):1269-1277.
2. Miller CG. Management of the difficult intubation in closed malpractice claims. ASA Newsletter. 2000;64(6):13-19. 3. Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000;90(3):745-756. 4. Frass M, Kofler J, Thalhammer F, et al. Clinical evaluation of a new visualized endotracheal tube (VETT). Anesthesiology. 1997;87(5):1262-1263. 5. Tuckey JP, Cook TM, Render CA. Forum. An evaluation of the levering laryngoscope. Anaesthesia. 1996;51(1):71-73. 6. Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anesth. 2003;50(6):611-613. 7. Agro F, Barzoi G, Montecchia F. Tracheal intubation using a Macintosh laryngoscope or a GlideScope in 15 patients with cervical spine immobilization (letter). Br J Anaesth. 2003;90(5):705-706. 8. Gorback MS. Management of the challenging airway with the Bullard laryngoscope. J Clin Anesth. 1991;3(6):473-477. 9. Bjoraker DG. The Bullard intubating laryngoscopes. Anesthesiol Rev. 1990;17(5):64-70. 10. Wu TL, Chou HC. A new laryngoscope: the combination intubating device. Anesthesiology. 1994;81(4):1085-1087. 11. Verghese C. Airway management. Curr Opin Anaesthesiol. 1999;12(6):667-674. 12. Benumof JL. Laryngeal mask airway and the ASA difficult airway algorithm. Anesthesiology. 1996;84(3):686-699. 13. Patel P, Verghese C. Delayed extubation facilitated with the use of a laryngeal mask airway in the intensive care unit. Anaesthesia. 2000;55(4):396. 14. Brimacombe J, Keller C, Hörmann C. Pressure support ventilation versus continuous positive airway pressure with the laryngeal
mask airway: a randomised, crossover study of anesthetized adult patients. Anesthesiology. 2000;92(6):1621-1623. 15. Dörges V, Ocker H, Wenzel V, Schmucker P. The laryngeal tube: a new simple airway device. Anesth Analg. 2000;90(5):1220-1222. 16. Gaitini LA, Vaida SJ, Somri M, Tome R, Yanovski B. A comparison of the Cobra, Perilaryngeal Airway, and Laryngeal Mask Airway Unique in spontaneously breathing adult patients. Anesthesiology. 2004;101:A518. 17. Gupta B, McDonald JS, Brooks JH, Mendenhall J. Oral fiberoptic intubation over a retrograde guidewire. Anesth Analg. 1989;68(4):517-519. 18. Sivarajan M, Stoler E, Kil HK, Bishop MJ. Jet ventilation using fiberoptic bronchoscopes. Anesth Analg. 1995;80(2):384-387. 19. Audenaert SM, Montgomery CL, Stone B, Akins RE, Lock RL. Retrograde-assisted fiberoptic tracheal intubation in children with difficult airways. Anesth Analg. 1991;73(5):660-664. 20. Klain M, Smith RB. High-frequency percutaneous transtracheal jet ventilation. Crit Care Med. 1977;5(6):280-287. 21. Enk D, Busse H, Meissner A, Van Aken H. A new device for oxygenation and drug administration by transtracheal jet ventilation. Anesth Analg. 1998;86:S203. 22. Safar P, Penninckx J. Cricothyroid membrane puncture with special cannula. Anesthesiology. 1967;28(5):943-948. 23. Safar P, Bircher NG. Cardiopulmonary Cerebral Resuscitation. 3rd ed. London, England: WB Saunders; 1988. 24. Wong EK, Bradrick JP. Surgical approaches to airway management for anesthesia practitioners. In: Hagberg CA, ed. Handbook of Difficult Airway Management. Philadelphia, PA: Churchill Livingstone; 2000:209-210. 25. Gibbs M, Walls R. Surgical airway. In: Hagberg CA, ed. Benumof’s Airway Management. 2nd ed. Philadelphia, PA: Mosby Elsevier; 2007:678-696. 26. Sarpellon M, Marson F, Nani R, Chiarini L, Bradariolo S, Fonzari C. Translaryngeal tracheostomy (TLT): a variant technique for use in hypoxemic conditions and in the difficult airway [in Italian]. Minerva Anestesiol. 1998;64(9):393-397.
Abbreviation Key AEC airway exchange catheter AHA American Heart Association ASA American Society of Anesthesiologists CCD charge-coupled device CMOS complementary metal oxide semiconductor CPAP continuous positive airway pressure CPR cardiopulmonary resuscitation DCI direct coupled interface DISS diameter index safety system DL direct laryngoscopy DLT double-lumen tube ED emergency department EF extra firm EMS emergency medical services ENT ear nose and throat ET endotracheal tube FOB fiber-optic bronchoscope Fr French ICU intensive care unit ID internal diameter ILMA intubating laryngeal mask airway
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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
ISO LCD LED LMA LT LTA MAC NICU NTSC OD OR PEEP PPV PVC PVP SGA Stat TFE TTJV USB VL
International Organization for Standardization liquid crystal display light-emitting diode laryngeal mask airway laryngeal tube laryngeal tracheal anesthesia Macintosh neonatal intensive care unit National Television System Committee outer diameter operating room positive end-expiratory pressure positive pressure ventilation polyvinyl chloride polyvinylpyrrolidone supraglottic airway sterile single-use blade tetrafluoroethylene transtracheal jet ventilation universal serial bus video laryngoscopy