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Pediatric Prehospital Airway Resuscitation Trial

RECRUITINGN/ASponsored by Ohio State University
Actively Recruiting
PhaseN/A
SponsorOhio State University
Started2024-05-20
Est. completion2029-08-31
Eligibility
Age24 Hours – 17 Years
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →

NCT06364280

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

Age: 24 Hours – 17 YearsHealthy volunteers accepted
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.

Conditions6

Child, OnlyCritical IllnessHeart Arrest, Out-Of-HospitalHeart DiseaseRespiratory Insufficiency in ChildrenWounds and Injuries

Locations10 sites

University of Airzona
Tucson, Arizona, 85721
Joshua Gaither, MD
Harbor-University of California Los Angeles Medical Center
Los Angeles, California, 90509
Marianne Gausche-Hill, MD
University of California Davis
Sacramento, California, 95817
Daniel Nishijima, MD
University of Colordao
Aurora, Colorado, 80045
Kathleen Adelgais, MD
Children's National Hospital
Washington D.C., District of Columbia, 20010
Kathleen Brown, MD

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