Pediatric Prehospital Airway Resuscitation Trial
Paused · Not applicable
Conditions studied: Heart Arrest, Out-Of-Hospital, Wounds and Injuries, Respiratory Insufficiency in Children, Child, Only, Critical Illness
In brief
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\].
Key facts
- Study ID
- NCT06364280
- Run by
- Ohio State University
- People needed
- 3000
- Starts
- 2024-05-20
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2026-04-07
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Airzona — Tucson, Arizona, United States
- Harbor-University of California Los Angeles Medical Center — Los Angeles, California, United States
- University of California Davis — Sacramento, California, United States
- University of Colordao — Aurora, Colorado, United States
- Children's National Hospital — Washington D.C., District of Columbia, United States
- Indiana University — Indianapolis, Indiana, United States
- Mecklenburg County Emergency Medical Services — Charlotte, North Carolina, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Dell Medical School, University of Texas at Austin — Austin, Texas, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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