Design of a novel clinical trial of prehospital pediatric airway management

1. Fink, EL, Prince, DK, Kaltman, JR, et al. Unchanged pediatric out-of-hospital cardiac arrest incidence and survival rates with regional variation in North America. Resuscitation 2016; 107: 121–128.
Google Scholar | Crossref | Medline2. Donoghue, AJ, Nadkarni, V, Berg, RA, et al. Out-of-hospital pediatric cardiac arrest: an epidemiologic review and assessment of current knowledge. Ann Emerg Med 2005; 46: 512–522.
Google Scholar | Crossref | Medline | ISI3. Atkins, DL, Everson-Stewart, S, Sears, GK, et al. Epidemiology and outcomes from out-of-hospital cardiac arrest in children: the resuscitation outcomes consortium epistry-cardiac arrest. Circulation 2009; 119: 1484–1491.
Google Scholar | Crossref | Medline | ISI4. Young, KD, Gausche-Hill, M, McClung, CD, et al. A prospective, population-based study of the epidemiology and outcome of out-of-hospital pediatric cardiopulmonary arrest. Pediatrics 2004; 114: 157–164.
Google Scholar | Crossref | Medline | ISI5. Lee, J, Yang, WC, Lee, EP, et al. Clinical survey and predictors of outcomes of pediatric out-of-hospital cardiac arrest admitted to the emergency department. Sci Rep 2019; 9: 7032.
Google Scholar | Crossref | Medline6. Centers for Disease Control and Prevention . National Center for Health Statistics, https://wonder.cdc.gov/controller/datarequest/D76;jsessionid=AF43C3212D521E1A2834FC768FD4 (accessed 27 January 2021).
Google Scholar7. Saikia, D, Mahanta, B. Cardiovascular and respiratory physiology in children. Indian J Anaesth 2019; 63(9): 690–697.
Google Scholar | Crossref | Medline8. Lammers, RL, Byrwa, MJ, Fales, WD, et al. Simulation-based assessment of paramedic pediatric resuscitation skills. Prehosp Emerg Care 2009; 13(3): 345–356.
Google Scholar | Crossref | Medline9. Brownstein, D, Shugerman, R, Cummings, P, et al. Prehospital endotracheal intubation of children by paramedics. Ann Emerg Med 1996; 28(1): 34–39.
Google Scholar | Crossref | Medline10. Aufderheide, TP, Lurie, KG. Death by hyperventilation: a common and life-threatening problem during cardiopulmonary resuscitation. Crit Care Med 2004; 32(Suppl. 9): S345–S351.
Google Scholar | Crossref | Medline11. Wang, HE, Simeone, SJ, Weaver, MD, et al. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med 2009; 54(5): 645.e1–652.e1.
Google Scholar | Crossref12. Wang, HE, Kupas, DF, Paris, PM, et al. Preliminary experience with a prospective, multi-centered evaluation of out-of-hospital endotracheal intubation. Resuscitation 2003; 58(1): 49–58.
Google Scholar | Crossref | Medline13. Youngquist, ST, Henderson, DP, Gausche-Hill, M, et al. Paramedic self-efficacy and skill retention in pediatric airway management. Acad Emerg Med 2008; 15(12): 1295–1303.
Google Scholar | Crossref | Medline14. Babl, FE, Vinci, RJ, Bauchner, H, et al. Pediatric pre-hospital advanced life support care in an urban setting. Pediatr Emerg Care 2001; 17(1): 5–9.
Google Scholar | Crossref | Medline15. Hansen, ML, Lin, A, Eriksson, C, et al. A comparison of pediatric airway management techniques during out-of-hospital cardiac arrest using the CARES database. Resuscitation 2017; 120: 51–56.
Google Scholar | Crossref | Medline16. Gausche, M, Lewis, RJ, Stratton, SJ, et al. Effect of out-of-hospital pediatric endotracheal intubation on survival and neurological outcome: a controlled clinical trial. JAMA 2000; 283: 783–790.
Google Scholar | Crossref | Medline | ISI17. Wang, HE, Schmicker, RH, Daya, MR, et al. Effect of a strategy of initial laryngeal tube insertion vs endotracheal intubation on 72-hour survival in adults with out-of-hospital cardiac arrest: a randomized clinical trial. JAMA 2018; 320: 769–778.
Google Scholar | Crossref | Medline18. Benger, JR, Kirby, K, Black, S, et al. Effect of a strategy of a supraglottic airway device vs tracheal intubation during out-of-hospital cardiac arrest on functional outcome: the AIRWAYS-2 randomized clinical trial. JAMA 2018; 320: 779–791.
Google Scholar | Crossref | Medline19. Hansen, M, Wang, H, Le, N, et al. Prospective evaluation of airway management in pediatric out-of-hospital cardiac arrest. Resuscitation 2020; 156: 53–60.
Google Scholar | Crossref | Medline20. Ostermayer, DG, Camp, EA, Langabeer, JR, et al. Impact of an extraglottic device on pediatric airway management in an urban prehospital system. West J Emerg Med 2019; 20: 962–969.
Google Scholar | Crossref | Medline21. Panchal, AR, Bartos, JA, Cabanas, JG, et al. Part 3: adult basic and advanced life support: 2020 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2020; 142: S366–S468.
Google Scholar | Crossref | Medline22. Mitchell, MS, Lee White, M, King, WD, et al. Paramedic King Laryngeal Tube airway insertion versus endotracheal intubation in simulated pediatric respiratory arrest. Prehosp Emerg Care 2012; 16(2): 284–288.
Google Scholar | Crossref | Medline23. Ritter, SC, Guyette, FX. Prehospital pediatric King LT-D use: a pilot study. Prehosp Emerg Care 2011; 15(3): 401–404.
Google Scholar | Crossref | Medline24. Chen, L, Hsiao, AL. Randomized trial of endotracheal tube versus laryngeal mask airway in simulated prehospital pediatric arrest. Pediatrics 2008; 122(2): e294–e297.
Google Scholar | Crossref | Medline25. Guyette, FX, Roth, KR, LaCovey, DC, et al. Feasibility of laryngeal mask airway use by prehospital personnel in simulated pediatric respiratory arrest. Prehosp Emerg Care 2007; 11(2): 245–249.
Google Scholar | Crossref | Medline26. Driver, BE, Prekker, ME, Klein, LR, et al. Effect of use of a bougie vs endotracheal tube and stylet on first-attempt intubation success among patients with difficult airways undergoing emergency intubation: a randomized clinical trial. JAMA 2018; 319: 2179–2189.
Google Scholar | Crossref | Medline27. Bonnette, AJ, Aufderheide, TP, Jarvis, JL, et al. Bougie-assisted endotracheal intubation in the pragmatic airway resuscitation trial. Resuscitation 2021; 158: 215–219.
Google Scholar | Crossref | Medline28. Rhode, MG, Vandborg, MP, Bladt, V, et al. Video laryngoscopy in pre—hospital critical care—a quality improvement study. Scand J Trauma Resusc Emerg Med 2016; 24: 84.
Google Scholar | Crossref | Medline29. Trimmel, H, Kreutziger, J, Fitzka, R, et al. Use of the glidescope ranger video laryngoscope for emergency intubation in the prehospital setting: a randomized control trial. Crit Care Med 2016; 44(7): e470–e476.
Google Scholar | Crossref | Medline30. Wayne, MA, McDonnell, M. Comparison of traditional versus video laryngoscopy in out-of-hospital tracheal intubation. Prehosp Emerg Care 2010; 14(2): 278–282.
Google Scholar | Crossref | Medline31. Nwanne, T, Jarvis, J, Barton, D, et al. Advanced airway management success rates in a national cohort of emergency medical services agencies. Resuscitation 2020; 146: 43–49.
Google Scholar | Crossref | Medline32. Jabre, P, Penaloza, A, Pinero, D, et al. Effect of bag-mask ventilation vs endotracheal intubation during cardiopulmonary resuscitation on neurological outcome after out-of-hospital cardiorespiratory arrest: a randomized clinical trial. JAMA 2018; 319: 779–787.
Google Scholar | Crossref | Medline33. Hansen, M, Lambert, W, Guise, JM, et al. Out-of-hospital pediatric airway management in the United States. Resuscitation 2015; 90: 104–110.
Google Scholar | Crossref | Medline34. Nichol, G, Brown, SP, Perkins, GD, et al. What change in outcomes after cardiac arrest is necessary to change practice? Results of an international survey. Resuscitation 2016; 107: 115–120.
Google Scholar | Crossref | Medline35. Quintana, M, Viele, K, Lewis, RJ. Bayesian analysis: using prior information to interpret the results of clinical trials. JAMA 2017; 318: 1605–1606.
Google Scholar | Crossref | Medline36. Lewis, RJ, Angus, DC. Time for clinicians to embrace their inner Bayesian? Reanalysis of results of a clinical trial of extracorporeal membrane oxygenation. JAMA 2018; 320: 2208–2210.
Google Scholar | Crossref | Medline37. Ryan, EG, Bruce, J, Metcalfe, AJ, et al. Using Bayesian adaptive designs to improve phase III trials: a respiratory care example. BMC Med Res Methodol 2019; 19: 99.
Google Scholar | Crossref | Medline38. U.S. Food and Drug Administration. Guidance for industry: adaptive design clinical trials for drugs and biologics. Rockville, MD: U.S. Food and Drug Administration, 2010, https://www.emwa.org/Documents/Freelancer/adaptivestudydesign/FDA%20adaptive%20design_Aug%202010.pdf (accessed 18 February 2021).
Google Scholar39. Pallmann, P, Bedding, AW, Choodari-Oskooei, B, et al. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med 2018; 16: 29.
Google Scholar | Crossref | Medline40. Berry, SM, Connor, JT, Lewis, RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA 2015; 313: 1619–1620.
Google Scholar | Crossref | Medline | ISI41. Hansen, M, Bosson, N, Gausche-Hill, M, et al. Critical factors in planning a pediatric prehospital airway trial. Prehosp Emerg Care. Epub ahead of print 1 June 2021. DOI: 10.1080/10903127.2021.1918808.
Google Scholar | Crossref | Medline42. Gausche-Hill, M, Lewis, RJ, Gunter, CS, et al. Design and implementation of a controlled trial of pediatric endotracheal intubation in the out-of-hospital setting. Ann Emerg Med 2000; 36(4): 356–365.
Google Scholar | Crossref | Medline43. Cho, H, Wendelberger, B, Gausche-Hill, M, et al. ICU-free days as a more sensitive primary outcome for clinical trials in critically ill pediatric patients. J Am Coll Emerg Physicians Open 2021; 2(4): e12479.
Google Scholar | Medline44. McGlothlin, AE, Viele, K. Bayesian hierarchical models. JAMA 2018; 320: 2365–2366.
Google Scholar | Crossref | Medline45. Nichol, G, Leroux, B, Wang, H, et al. Trial of continuous or interrupted chest compressions during CPR. N Engl J Med 2015; 373: 2203–2214.
Google Scholar | Crossref | Medline46. Wang, HE, Benger, JR. Endotracheal intubation during out-of-hospital cardiac arrest: new insights from recent clinical trials. J Am Coll Emerg Physicians Open 2020; 1(1): 24–29.
Google Scholar | Crossref | Medline

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