Pediatric Prehospital Airway Resuscitation Trial
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
🗓️ Study Start (Actual) 20 May 2024
🗓️ Primary Completion (Estimated) 31 August 2029
✅ Study Completion (Estimated) 30 September 2029
👥 Enrollment (Estimated) 3000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tucson, Arizona, United States
📍 Los Angeles, California, United States
📍 Sacramento, California, United States
📍 Aurora, Colorado, United States
📍 Washington, District of Columbia, United States
📍 Indianapolis, Indiana, United States
📍 Charlotte, North Carolina, United States
📍 Columbus, Ohio, United States
📍 Austin, Texas, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

  • 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.
Ages Eligible for Study: 24 Hours to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 April 2024
  • First Submitted that Met QC Criteria 11 April 2024
  • First Posted 15 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024