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Recruiting NCT06364280

Pediatric Prehospital Airway Resuscitation Trial

Trial Parameters

Condition Heart Arrest, Out-Of-Hospital
Sponsor Ohio State University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3,000
Sex ALL
Min Age 24 Hours
Max Age 17 Years
Start Date 2024-05-20
Completion 2029-08-31
Interventions
BVMSGAETI

Brief 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 Criteria

Inclusion criteria are: * 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 criteria are: * 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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