Testing airway management techniques for critically ill children in emergencies
Pediatric Prehospital Airway Resuscitation Trial
This study tests different ways to help critically ill children breathe during emergencies to see which method works best for their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 24 Hours to 17 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 10 sites (Tucson, Arizona and 9 other locations) |
| Trial ID | NCT06364280 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of various prehospital airway management strategies for critically ill children experiencing cardiac arrest, respiratory failure, or major trauma. Emergency Medical Services (EMS) personnel will implement different interventions, including bag-valve-mask ventilation (BVM), supraglottic airway (SGA) insertion, and endotracheal intubation (ETI), to determine which method leads to the best outcomes. The study is structured in two stages, with the first stage comparing BVM-only and BVM followed by SGA, and the second stage comparing the winner of the first stage against BVM followed by ETI. The primary goal is to assess 30-day ICU-free survival rates among participants.
Who should consider this trial
Good fit: Ideal candidates are children aged 24 hours to under 18 years who are experiencing cardiac arrest, major trauma, or respiratory failure requiring active airway management.
Not a fit: Patients with pre-existing tracheostomy, do-not-resuscitate status, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve airway management techniques in emergency situations, leading to better survival rates for critically ill children.
How similar studies have performed: Previous studies have highlighted the need for rigorous trials in pediatric airway management, indicating that this approach is both necessary and timely.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tucson, Arizona and 9 other locations
- University of Airzona — Tucson, Arizona, United States (Recruiting)
- Harbor-University of California Los Angeles Medical Center — Los Angeles, California, United States (Recruiting)
- University of California Davis — Sacramento, California, United States (Recruiting)
- University of Colordao — Aurora, Colorado, United States (Not_yet_recruiting)
- Children's National Hospital — Washington, District of Columbia, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Mecklenburg County Emergency Medical Services — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Dell Medical School, University of Texas at Austin — Austin, Texas, United States (Not_yet_recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Henry E Wang, MD, MS — Ohio State University
- Study coordinator: Henry E Wang, MD, MS
- Email: henry.wang@osumc.edu
- Phone: 614-293-8305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.