Critical Illness Clinical Trial
— Pedi-PARTOfficial title:
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].
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | September 30, 2029 |
Est. primary completion date | August 31, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Hours to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | National Heart, Lung, and Blood Institute (NHLBI), University of Utah |
Bosson N, Hansen M, Gausche-Hill M, Lewis RJ, Wendelberger B, Shah MI, VanBuren JM, Wang HE. Design of a novel clinical trial of prehospital pediatric airway management. Clin Trials. 2022 Feb;19(1):62-70. doi: 10.1177/17407745211059855. Epub 2021 Dec 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day ICU-free survival | The number of days in the first 30 days after the treatment event where: 1) the patient was not known to have died; and 2) the patient was not hospitalized in the intensive care unit. ICU admission/discharge criteria will not be standardized. | 30 days | |
Secondary | Neurologic outcome upon hospital discharge | Outcome will be measured with Pediatric Cerebral Performance Category score (PCPC - 1 = normal, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, 6 = dead). | Identified through end of study but no later than 30 days after final enrollment. |
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