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• W3048993728 abstract "See Article, p 664 In the spring of 2020, the rapid, global spread of the highly contagious and novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus triggered a worldwide pandemic. Much remains unknown about coronavirus disease 2019 (COVID-19), the disease caused by SARS-CoV-2 infection, and no vaccine or definitive treatment has yet emerged. As a result, clinicians who care for infected patients have raced to develop solutions to technical challenges posed by a highly transmissible, potentially lethal virus that enters via the respiratory tract. For anesthesiologists in particular, strategies to reduce viral transmission during airway management have led to novel technical strategies, including aerosol boxes and manual ventilation techniques. While innovation has always been part of medical care, a larger question is how best to evaluate and disseminate these inventions. “Word of mouth,” private business ventures, and, more recently, the Internet have been traditional routes by which the news of innovative solutions has spread. The role of peer-reviewed publications, however, is less clear. Academic journals normally focus on exploring fundamental scientific principles or evaluating diagnostic and therapeutic techniques. But does this mission also include the vetting of devices invented to solve a specific technical challenge? And if so, what vetting thresholds should a device meet? In this issue of Anesthesia & Analgesia, Seger et al1 describe the development of a flexible aerosol box and demonstrate its efficacy in preventing droplet spread during simulated airway management. Although the basis of Seger’s invention can be found in pre-World War II glove boxes that were developed to work with radioactive materials,2 the translation to airway management in COVID-19 patients introduces several new challenges. Unlike radioactivity, droplet spread cannot be readily monitored, so users of the glove box may unknowingly contaminate themselves or others. Manipulating radioactive material in a glove box probably does not require as much freedom of motion as may be needed for airway management. All of the equipment that might be needed to manipulate radioactive materials can be placed into a glove box before starting, whereas airway management may require that additional equipment be introduced rapidly and with little or no warning. Finally, encountering a problem while manipulating radioactive materials inside a glove box does not normally require that the glove box be quickly dismantled, but managing an unanticipated difficult airway may require rapid, unfettered access to the patient. Seger et al1 begin by describing previous attempts to develop an intubation “box” and identifying the limitations of currently available devices. They then explain how their device overcomes these limitations, in part by being flexible, disposable, and capable of negative pressure to reduce droplet spread. They report the results of a simulation study that used dye to model the spread of droplets during intubation. Finally, they describe the rescue procedures that would be required if the “box” had to be removed quickly. Taken together, they make a reasonable case for a device that may help to reduce droplet spread during intubation in patients with COVID-19, even without real-world testing. But does their device and validation process meet the threshold for publication? The use of an aerosol box to prevent the spread of infection has been previously reported elsewhere3–6 and even in this journal.7 The concept itself is not novel, and its potential limitations can easily be imagined by any clinician who has managed an airway. In the setting of prior publications that describe a similar device with an identical purpose, how should reviewers decide when a gadget becomes a paper? One metric might be if the gadget solves a problem that is widely considered to be difficult. Oral airways that prevent upper airway collapse existed long before the invention of the supraglottic airway (SGA), but they did not facilitate both ventilation and intubation. Of the many applications of the SGA, its ability to provide an intubating channel while simultaneously allowing the patient to be ventilated has clearly saved lives.8 Another metric might be dramatically improved usability. Pulmonary artery catheterization had been performed routinely before Swan famously described his catheter in 1970.9 Swan’s insight was to develop a device that could be used without fluoroscopy at the bedside and could remain in place for prolonged periods of time. Finally, a device might alter clinical risk assessment. Although studies have generally not proven that pulse oximetry improves perioperative outcomes,10 it does reduce malpractice premiums11 and is recommended in major society guidelines for procedural sedation.12 We do not yet know if Seger’s device meets these criteria. The true efficacy of an intubation box would be its ability to reduce the risk of health care worker infection. This question remains unanswered not only with Seger’s device but with every intubation box that has been described so far because the true risk of coronavirus infection associated with airway management is not known. Likewise, comparing the ease of use of Seger’s device to similar intubation boxes suffers from familiarity bias. Moreover, the unintended consequences of intubation boxes may limit any real-world utility. In a 2020 simulation study, Begley et al5 found that >1 minute was required for 58% of attempts at endotracheal intubation if an aerosol box was used. Inability to rapidly remove the box if full access to the airway is urgently required may ultimately worsen airway management outcomes and also increase the risk of health care worker infection. Lastly, although concerns raised by cleaning and sterilizing aerosol boxes may be allayed by making the box disposable, the global introduction of yet another disposable plastic device raises sustainability concerns.13 An article describing a device that was developed in response to the current pandemic but does not by itself advance medical practice raises a larger question: Does news of its development merit publication in a scientific journal? It is difficult to derive generalizable knowledge from these reports and to understand how they advance the science of medicine. While not addressing the above points directly, Seger et al1 make a good-faith effort. Using a dye technique, they demonstrate that their box caused less contamination of hands and arms. They show that their device was able to contain smoke (which was used as a visible substitute for aerosol) better than rigid boxes, even without the use of suction. Finally, they demonstrate that their device can be dismantled and removed quickly and easily during a simulated airway emergency. They also discuss the limitations of their device and suggest areas for future research. That Seger et al1 have considered the potential adverse consequences of their airway box differentiates this article from other publications on this topic. The current SARS-CoV-2 pandemic has led many clinicians to develop novel solutions to an unprecedented disease about which little is known. Supplying genuinely new information that can improve patient care in a timely fashion is crucial to the resolution of this crisis. However, publication in medical journals should ideally be reserved for manuscripts that offer new scientific knowledge. Many institutions have taken steps to minimize the spread of COVID-19 via aerosols that are generated during airway management, including the development of intubation boxes that are based on traditional glove boxes and include some kind of evacuation mechanism. We have previously discussed the potential risks of using homemade devices for patient care.14 Caveats such as unintended consequences, workarounds, and medicolegal jeopardy also apply to intubation boxes, along with an additional concern that a faulty design may in this case place the clinician at risk. Seger et al1 have developed a new aerosol box that addresses many of the limitations of their predecessors and have been unusually thoughtful in their analysis of its safety and efficacy in a laboratory setting. Although the true value of their airway box is not yet known, Seger et al1 have carefully evaluated their device to the best of their ability while being mindful of the potential for harm. The completeness of their approach offers a possible blueprint for future publications of this type. DISCLOSURES Name: Keith J. Ruskin, MD. Contribution: This author participated in the conception and writing of this editorial. Conflicts of Interest: K. J. Ruskin is partially supported by Federal Aviation Administration Cooperative Research Agreement 692M151940006: Air Traffic Organization Alarm Management. This funding did not support any of the work involved in the preparation of this manuscript. Name: Avery Tung, MD. Contribution: This author participated in the conception and writing of this editorial. Conflicts of Interest: A. Tung receives a salary as Executive Editor for Critical Care for Anesthesia & Analgesia. This manuscript was handled by: Narasimhan Jagannathan, MD, MBA." @default.
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• W3048993728 title "When Does a Gadget Become a Paper?" @default.
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