NCT07582211 Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

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This trial targets 36 participants in total. It began in 2026-08-31 with a primary completion date of 2027-07.

Brief 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.

Eligibility Criteria

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 albuterol for over 150 minutes prior to being approached for consent. 4. If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent. Note: Blood gas values are not required for eligibility confirmation. 5. Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician. 6. Presence of a tracheostomy or a baseline requirement for noninvasive ventilation. 7. Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis). 8. Absolute or relative contraindication to BPAP, defined as any of the following: 1. Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull). 2. Uncontrollable vomiting (i.e., \> 3 episodes within approximately 1 hour prior to being approached for consent). 3. Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \< 70 + \[2 x age in years\]). 4. Glasgow Coma Score of 8 or less. 5. Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema). 9. Weight \< 20 kg. 10. Presence of an intra-abdominal mass compressing the stomach (e.g., due to tumor or large volume ascites) through EMR or medical history. 11. Known or suspected pregnancy by history or if pregnancy test completed by clinical team. 12. Any medical condition that, in the opinion of a site investigator, could 1) lead to difficulty complying with protocol procedures, 2) interfere with the safe completion of the study, or 3) affect the validity of the endpoint assessments. 13. PRAM score less than 7 or greater than 10 based on concurrent clinical assessment by a healthcare provider after completion of standard first-line therapies, which is defined as receiving all of the following prior to ED arrival or during the ED encounter for this acute asthma exacerbation: 1. Albuterol with or without ipratropium bromide, either at least 3 albuterol doses via inhalation method (e.g., metered-dose inhaler (MDI) or nebulized) or at least one hour of continuous albuterol (i.e., continuous nebulized albuterol or three consecutive intermittent nebulized albuterol treatments as bridging therapy). 2. Corticosteroids (e.g., Prednisolone, Prednisone, Dexamethasone/Decadron, or Methylprednisolone) via enteral, intravenous, or intramuscular methods. Note: Oxygen is not a required first-line therapy. 14. Do not require continuous albuterol or a second round of albuterol treatments (e.g., three back-to-back treatments or one hour of burst albuterol treatment) following completion of standard first-line therapies.

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