protocolSection identificationModule nctId: NCT06364280, orgStudyIdInfo id: 2023X0135, secondaryIdInfos id: UG3HL165019, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165019, secondaryIdInfos id: U24HL165014, type: NIH, link: https://reporter.nih.gov/quickSearch/U24HL165014, briefTitle: Pediatric Prehospital Airway Resuscitation Trial, acronym: Pedi-PART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-08-31, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: University of Utah, descriptionModule briefSummary: 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. \[Winner of Stage I\]., conditionsModule conditions: Heart Arrest, Out-Of-Hospital, conditions: Wounds and Injuries, conditions: Respiratory Insufficiency in Children, conditions: Child, Only, conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework.The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\].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. \[Winner of Stage I\].The interventions will be quasi-randomized using alternate day assignment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: BVM, interventions name: SGA, interventions name: ETI, outcomesModule primaryOutcomes measure: 30-day ICU-free survival, secondaryOutcomes measure: Neurologic outcome upon hospital discharge, eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False