Clinical trial NCT06364280: Pediatric Prehospital Airway Resuscitation Trial
Official title: Pediatric Prehospital Airway Resuscitation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Utah
First posted: 2024-04-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 24
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day ICU-free survival
timeFrame: 30 days
Secondary outcomes:
measure: Neurologic outcome upon hospital discharge
timeFrame: Identified through end of study but no later than 30 days after final enrollment.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Airzona
state: Arizona
city: Los Angeles
country: United States
facility: Harbor-University of California Los Angeles Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Aurora
country: United States
facility: University of Colordao
state: Colorado
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Charlotte
country: United States
facility: Mecklenburg County Emergency Medical Services
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Austin
country: United States
facility: Dell Medical School, University of Texas at Austin
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Ohio State University
name: Henry E Wang, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.