Bilevel Positive Airway Pressure (BPAP) for Severe Asthma Exacerbations: A Randomized Controlled Trial
Columbia University
Summary
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.
Description
Severe asthma exacerbations are a common reason for pediatric emergency department (ED) visits, hospital admissions, and pediatric intensive care unit (PICU) use. Although first-line therapies such as inhaled beta-agonists, anticholinergics, and systemic corticosteroids are well established, the optimal second-line treatment for children who remain in moderate to severe respiratory distress is unclear. Bilevel positive airway pressure (BPAP) is a form of non-invasive positive pressure ventilation that may improve airway patency, reduce work of breathing, improve ventilation-perfusion matching…
Eligibility
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation. 2. 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). Exclusion Criteria: 1. Prior participation in the study. 2. 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. 3. Receipt of continuous albutero…
Interventions
- DeviceBilevel positive airway pressure ventilation
This study involves non-invasive positive pressure ventilation (NIPPV) delivered as bilevel positive airway pressure (BPAP) in children aged 5-17 years presenting to the pediatric emergency department with severe asthma exacerbations. BPAP will be administered using FDA-cleared devices according to their intended use and standard clinical practice. Therapy will be delivered via an appropriately fitted nasal or face mask and managed by trained clinical staff. Ventilator settings will be adjusted at the discretion of the treating clinician, and continuous bronchodilator therapy may be delivered through the BPAP circuit per manufacturer recommendations or site practice.
Locations (3)
- Columbia University Irving Medical CenterNew York, New York
- Nationwide Children's HospitalColumbus, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania