RecruitingNot ApplicableNCT06364280

Pediatric Prehospital Airway Resuscitation Trial


Sponsor

Ohio State University

Enrollment

3,000 participants

Start Date

May 20, 2024

Study Type

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

Min Age: 24 HoursMax Age: 17 Years

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

DEVICEBVM

Bag-Valve-Mask Ventilation

DEVICESGA

Supraglottic Airway

DEVICEETI

Endotracheal Intubation


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT06364280


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