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Search / Trial NCT06364280

Pediatric Prehospital Airway Resuscitation Trial

Launched by OHIO STATE UNIVERSITY · Apr 11, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Airway Management Intubation, Intratracheal Emergency Medical Services Children Heart Arrest Injuries Respiratory Insufficiency

ClinConnect Summary

The Pediatric Prehospital Airway Resuscitation Trial is a clinical study aimed at finding the best ways to manage airways in critically ill children who experience life-threatening situations like heart arrest or severe injuries. The trial involves different strategies that emergency medical teams can use, such as providing breathing support with a bag-mask (BVM) alone, using a bag-mask followed by a supraglottic airway (SGA), or a bag-mask followed by endotracheal intubation (ETI). The main goal of the study is to see which method helps children survive without needing intensive care for 30 days.

To participate in this trial, children must be aged between 24 hours and 17 years old and require emergency treatment for conditions like cardiac arrest, major trauma, or breathing difficulties. Unfortunately, children who have a tracheostomy, those who are pregnant, or those whose airway management is already being handled by a non-study EMS agency cannot take part. If eligible, participants will receive one of the airway management strategies during an emergency call, and the trial is designed to gather data to determine the most effective approach. This study aims to improve emergency care for children in critical situations and is currently recruiting participants.

Gender

ALL

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.

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Milwaukee, Wisconsin, United States

Sacramento, California, United States

Indianapolis, Indiana, United States

Washington, District Of Columbia, United States

Columbus, Ohio, United States

Tucson, Arizona, United States

Los Angeles, California, United States

Aurora, Colorado, United States

Charlotte, North Carolina, United States

Austin, Texas, United States

Patients applied

0 patients applied

Trial Officials

Henry E Wang, MD, MS

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported