About this trial
The goal of this clinical trial is to assess the feasibility of early initiation of bilevel positive airway pressure (BPAP) in the emergency department (ED) for children with severe asthma exacerbations. It will also collect preliminary data on the safety and potential effectiveness of this approach.
The main questions it aims to answer are:
1. Can eligible patients be successfully enrolled and complete study procedures across multiple sites? 2. What safety events occur with early BPAP use in this population? 3. How do clinical outcomes (such as symptom improvement and need for intensive care) compare between early BPAP and standard care?
Researchers will compare early initiation of BPAP plus standard asthma therapy to standard asthma therapy alone to determine whether early BPAP is a feasible and potentially beneficial treatment strategy.
Participants will 1) receive standard asthma therapy with or without early BPAP in the ED, 2) be monitored closely during the ED visit and hospitalization, and 3) have clinical data collected from routine care, including asthma severity scores, treatments, and outcomes.
The study will enroll approximately 36 participants (about 12 per site) across three sites over one year to inform a future multicenter randomized controlled trial.
Eligibility criteria
Qualifiers
5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.
Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above).
Disqualifiers
Prior participation in the study.
Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization.
Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.
If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.
Trial design
Treatments tested in this trial
- Bilevel positive airway pressure ventilation
Treatment groups
Sponsors and collaborators
Columbia University
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Nationwide Children's Hospital
Collaborator
University of Utah
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator