title: Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART).
abstract: Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-h survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include (1) initial airway management with ETI and (2) initial airway management with LT. The primary and secondary trial outcomes are 72-h survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA.
authors: Department of Emergency Medicine, University of Alabama School of Medicine, Birmingham, AL, United States. Electronic address: hwang@uabmc.edu.
authors: Henry E
authors: HE
authors: Wang
authors: Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, United States. Electronic address: dprince@uw.edu.
authors: David K
authors: DK
authors: Prince
authors: Department of Emergency Medicine, University of Alabama School of Medicine, Birmingham, AL, United States. Electronic address: swstephens@uabmc.edu.
authors: Shannon W
authors: SW
authors: Stephens
authors: Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, United States. Electronic address: hherren@uw.edu.
authors: Heather
authors: H
authors: Herren
authors: Department of Emergency Medicine, Oregon Health and Science University, Portland, OR, United States. Electronic address: dayam@ohsu.edu.
authors: Mohamud
authors: M
authors: Daya
authors: MedStar, Inc., Fort Worth, TX, United States. Electronic address: nrichmond@medstar911.org.
authors: Neal
authors: N
authors: Richmond
authors: St Vincent's Medical Center, Erie, PA, United States; Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: jcarlson@svhs.org.
authors: Jestin
authors: J
authors: Carlson
authors: Department of Emergency Medicine, Oregon Health and Science University, Portland, OR, United States. Electronic address: wardenc@ohsu.edu.
authors: Craig
authors: C
authors: Warden
authors: Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, United States. Electronic address: colella@mcw.edu.
authors: M Riccardo
authors: MR
authors: Colella
authors: Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: brienzaam@upmc.edu.
authors: Ashley
authors: A
authors: Brienza
authors: Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, United States. Electronic address: taufderh@mcw.edu.
authors: Tom P
authors: TP
authors: Aufderheide
authors: Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States. Electronic address: aidris@sbcglobal.net.
authors: Ahamed H
authors: AH
authors: Idris
authors: Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, United States. Electronic address: rschmick@uw.edu.
authors: Robert
authors: R
authors: Schmicker
authors: Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, United States. Electronic address: sjmay@uw.edu.
authors: Susanne
authors: S
authors: May
authors: Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, United States. Electronic address: nichol@uw.edu.
authors: Graham
authors: G
authors: Nichol
mesh_terms: D058109:Airway Management; D018592:Cross-Over Studies; D006801:Humans; D007442:Intubation, Intratracheal; D017214:Laryngeal Masks; D058687:Out-of-Hospital Cardiac Arrest / Q000628:therapy*; D012107:Research Design; D016896:Treatment Outcome
keywords: Airway management; Cardiopulmonary arrest; Clinical trials; Emergency medical services; Intubation (intratracheal); Resuscitation