Pediatric Prehospital Airway Resuscitation Trial

Not Applicable

Recruiting

• Conditions: Respiratory Insufficiency in Children; Heart Arrest, Out-Of-Hospital; Child, Only; Critical Illness; Wounds and Injuries
• Interventions: Device: BVM; Device: SGA; Device: ETI

• Registration Number: NCT06364280
• Lead Sponsor: Ohio State University

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. \[Winner of Stage I\].

Detailed Description

Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize the delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide resuscitation care for critically ill children, prehospital EMS personnel are often the first to perform life-saving airway management.

The most common prehospital airway management techniques (bag-valve-mask ventilation \[BVM\], endotracheal intubation \[ETI\], and supraglottic airway insertion \[SGA\]) have important trade-offs between risks and benefits. Despite the challenges of ETI and national recommendations favoring BVM, many EMS personnel favor ETI over BVM. Newer SGA devices such as the laryngeal tube (LT), laryngeal mask airway (LMA), and i-gel® have not been compared with other techniques in children. National organizations, including the Agency for Healthcare Research and Quality, have declared the need for new, rigorous trials of all techniques to determine the best strategies for prehospital airway management in children. Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway.

The Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) will determine the best strategies for prehospital airway management in critically ill children. The trial aims are Aim I-Primary Objective (Effectiveness)-Stage I: Determine if \[BVM-only\] or \[BVM followed by SGA\] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if \[winner of Stage I\] or \[BVM followed by ETI\] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions. Aim 2- Secondary Objective (Safety)-Stage I: Determine if \[BVM followed by SGA\] results in fewer prehospital and hospital safety events compared with \[BVM-only\] in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if the winner of Stage I results in fewer safety events compared with \[BVM followed by ETI\].

The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial (BASiC-PT) design and will be executed in two sequential stages. Stage I: Determine if \[BVM-only\] or \[BVM followed by SGA\] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if \[winner of Stage I\] or \[BVM followed by ETI\] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions.

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-15
• Study Start: 2024-05-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2029-08-31
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVM followed by SGA [BVM+SGA]	SGA	Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).
BVM followed by ETI [BVM+ETI]	BVM	Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).
BVM followed by ETI [BVM+ETI]	ETI	Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).
BVM-only	BVM	Initial strategy of airway management using Bag-Valve-Mask (BVM) only.
BVM followed by SGA [BVM+SGA]	BVM	Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).

Primary Outcome Measures

Name	Time	Method
30-day ICU-free survival	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Neurologic outcome upon hospital discharge	Identified through end of study but no later than 30 days after final enrollment.	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).

Trial Locations

Locations (10)

Harbor-University of California Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

University of Airzona; 🇺🇸 Tucson, Arizona, United States

Mecklenburg County Emergency Medical Services; 🇺🇸 Charlotte, North Carolina, United States

Dell Medical School, University of Texas at Austin; 🇺🇸 Austin, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Colordao; 🇺🇸 Aurora, Colorado, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States