Pediatric Prehospital Airway Resuscitation Trial

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
University of Airzona
RECRUITING
Tucson
California
Harbor-University of California Los Angeles Medical Center
RECRUITING
Los Angeles
University of California Davis
RECRUITING
Sacramento
Colorado
University of Colordao
RECRUITING
Aurora
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Indiana
Indiana University
RECRUITING
Indianapolis
North Carolina
Mecklenburg County Emergency Medical Services
RECRUITING
Charlotte
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Texas
Dell Medical School, University of Texas at Austin
RECRUITING
Austin
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Henry E Wang, MD, MS
henry.wang@osumc.edu
614-293-8305
Backup
Jennifer Frey, PhD
jennifer.frey2@osumc.edu
614-293-8305
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 3000
Treatments
Active_comparator: BVM-only
Initial strategy of airway management using Bag-Valve-Mask (BVM) only.
Active_comparator: BVM followed by SGA [BVM+SGA]
Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).
Active_comparator: BVM followed by ETI [BVM+ETI]
Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).
Related Therapeutic Areas
Sponsors
Collaborators: University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Ohio State University

This content was sourced from clinicaltrials.gov