RECRUITING

Pediatric Prehospital Airway Resuscitation Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. \[Winner of Stage I\].

Official Title

Pediatric Prehospital Airway Resuscitation Trial

Quick Facts

Study Start:2024-05-20
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06364280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Hours to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Henry E Wang, MD, MS
CONTACT
614-293-8305
henry.wang@osumc.edu
Jennifer Frey, PhD
CONTACT
614-293-8305
jennifer.frey2@osumc.edu

Principal Investigator

Henry E Wang, MD, MS
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

University of Airzona
Tucson, Arizona, 85721
United States
Harbor-University of California Los Angeles Medical Center
Los Angeles, California, 90509
United States
University of California Davis
Sacramento, California, 95817
United States
University of Colordao
Aurora, Colorado, 80045
United States
Children's National Hospital
Washington, District of Columbia, 20010
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Mecklenburg County Emergency Medical Services
Charlotte, North Carolina, 28208
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Ohio State University

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

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

Study Start Date2024-05-20
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

  • airway management
  • intubation, intratracheal
  • emergency medical services
  • children
  • heart arrest
  • injuries
  • respiratory insufficiency

Additional Relevant MeSH Terms

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