Pediatric Prehospital Airway Resuscitation Trial

NCT06364280 | Recruiting DMC FDA Device

• 5 other identifiers: 2023X0135UG3HL165019U24HL165014UH3HL165019R01HL181356
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 10

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neurologic outcome upon hospital discharge

  Identified through end of study but no later than 30 days after final enrollment.

Study Arms (3)

BVM-only

ACTIVE COMPARATOR

Initial strategy of airway management using Bag-Valve-Mask (BVM) only.

Device: BVM

BVM followed by SGA [BVM+SGA]

ACTIVE COMPARATOR

Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).

Device: BVM; Device: SGA

BVM followed by ETI [BVM+ETI]

ACTIVE COMPARATOR

Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).

Device: BVM; Device: ETI

Interventions

BVM DEVICE

Bag-Valve-Mask Ventilation

BVM followed by ETI [BVM+ETI]; BVM followed by SGA [BVM+SGA]; BVM-only

SGA DEVICE

Supraglottic Airway

BVM followed by SGA [BVM+SGA]

ETI DEVICE

Endotracheal Intubation

BVM followed by ETI [BVM+ETI]

Eligibility Criteria

• Age: 24 Hours - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Utah: collaborator

Study Sites (10)

University of Airzona

Tucson, Arizona, 85721, United States

RECRUITING

Harbor-University of California Los Angeles Medical Center

Los Angeles, California, 90509, United States

RECRUITING

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

University of Colordao

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Mecklenburg County Emergency Medical Services

Charlotte, North Carolina, 28208, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Dell Medical School, University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34875893 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Wounds and Injuries; Critical Illness; Heart Arrest; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Henry E Wang, MD, MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry E Wang, MD, MS

CONTACT

614-293-8305; henry.wang@osumc.edu

Jennifer Frey, PhD

CONTACT

614-293-8305; pedi-part@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)