Pediatric Prehospital Airway Resuscitation Trial
Ohio State University
3,000 participants
May 20, 2024
INTERVENTIONAL
Conditions
Summary
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. \[Winner of Stage I\].
Eligibility
Inclusion Criteria4
- At least 24 hours old and \<18 years old
- Cardiopulmonary arrest, major trauma or respiratory failure
- Life-saving care initiated or continued by Pedi-PART EMS personnel as part of an emergency "9-1-1" response
- Requiring active airway management (BVM or higher level of respiratory support
Exclusion Criteria7
- Prisoners
- Pre-existing tracheostomy
- Pre-existing do-not-resuscitate/do-not-intubate status
- Visibly or known to be pregnant
- Initial advanced airway attempt by an EMS agency not affiliated with the study
- Interfacility transports
- EMS personnel will use bystander reports or follow local protocols to establish patient age and pregnancy status.
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Interventions
Bag-Valve-Mask Ventilation
Supraglottic Airway
Endotracheal Intubation
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06364280