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. \[Winner of Stage I\].
Heart Arrest, Out-Of-Hospital, Wounds and Injuries, Respiratory Insufficiency in Children, Child, Only, Critical Illness
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. \[Winner of Stage I\].
Pediatric Prehospital Airway Resuscitation Trial
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University of Airzona, Tucson, Arizona, United States, 85721
Harbor-University of California Los Angeles Medical Center, Los Angeles, California, United States, 90509
University of California Davis, Sacramento, California, United States, 95817
University of Colordao, Aurora, Colorado, United States, 80045
Children's National Hospital, Washington, District of Columbia, United States, 20010
Indiana University, Indianapolis, Indiana, United States, 46202
Mecklenburg County Emergency Medical Services, Charlotte, North Carolina, United States, 28208
Nationwide Children's Hospital, Columbus, Ohio, United States, 43205
Dell Medical School, University of Texas at Austin, Austin, Texas, United States, 78712
Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226
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.
For general information about clinical research, read Learn About Studies.
24 Hours to 17 Years
ALL
No
Ohio State University,
Henry E Wang, MD, MS, PRINCIPAL_INVESTIGATOR, Ohio State University
2029-09-30