Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorColumbia University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Bilevel positive airway pressure ventilation
DeviceThis 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: BPAP plus continuous albuterolExperimental treatment 1 intervention
Group B: Continuous albuterol aloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of eligible patients who consent
Proportion of approached, eligible patients who provide consent.
Time frame
From screening through randomization, up to 2 hours2
Proportion of participants who adhere to the BPAP protocol among all those assigned to the BPAP arm
Proportion of participants in the intervention arm who receive \> 1 hour \& 45 minutes of BPAP during the planned 2-hour intervention period without unplanned interruption (\> 15 consecutive minutes), unless weaned off continuous albuterol.
Time frame
From randomization through end of 2-hour interventionSecondary outcomes
1
Potential efficacy outcome: Change in Pediatric Respiratory Assessment Measure (PRAM) score
Change in Pediatric Respiratory Assessment Measure (PRAM) score from the pre-intervention to post-intervention assessment. The PRAM score ranges from 0 to 12, with higher scores indicating greater acute asthma exacerbation severity. Scores are categorized as mild (0-3), moderate (4-7), and severe (8-12).
Time frame
Pre-intervention to end of intervention, approximately 3 hours total2
Potential efficacy outcome: Duration of continuous albuterol use
Duration of continuous albuterol therapy
Time frame
From randomization through hospital discharge beyond the intervention period, up to 120 hours.3
Potential efficacy outcome: Duration of BPAP use
Duration of BPAP use
Time frame
From randomization through hospital discharge beyond the intervention period, up to 120 hours4
Potential efficacy outcome: PICU admission
Proportion of participants requiring admissions to the pediatric intensive care unit during the index ED visit
Time frame
Disposition determined 2 hours after completion of the intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov