MedTrace Logo

Pediatric Prehospital Airway Resuscitation Trial

NCT06364280 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-04-07

No results posted yet for this study

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. \[Winner of Stage I\].

Conditions

  • Heart Arrest, Out-Of-Hospital
  • Wounds and Injuries
  • Respiratory Insufficiency in Children
  • Child, Only
  • Critical Illness

Interventions

DEVICE

BVM

Bag-Valve-Mask Ventilation

DEVICE

SGA

Supraglottic Airway

DEVICE

ETI

Endotracheal Intubation

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Utah

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Henry E Wang, MD, MS · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2029-08-31
Completion
2029-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06364280 on ClinicalTrials.gov