Using BiPAP for Children with Moderate to Severe Asthma Attacks
Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial
This study tests if using BiPAP along with regular asthma treatment can help children aged 5 to 17 with moderate to severe asthma attacks breathe better and need less medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05848115 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of bi-level positive airway pressure (BiPAP) in children aged 5 to 17 who are experiencing moderate to severe asthma attacks in the emergency department. The study aims to determine if starting BiPAP alongside continuous beta-agonist therapy can reduce the duration of beta-agonist treatment and improve lung function. Participants will receive standard asthma treatment and, if symptoms persist, will be enrolled to use BiPAP while continuing their medication. The trial will also assess any potential side effects associated with BiPAP use compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 17 with a prior asthma diagnosis who present with moderate to severe asthma exacerbations.
Not a fit: Patients with non-asthma causes of wheezing or those requiring invasive mechanical ventilation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to quicker recovery times and improved management of asthma attacks in children.
How similar studies have performed: While the use of BiPAP in asthma management is being explored, this specific approach in pediatric patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation * Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids) * PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy Exclusion Criteria: * Prior participation in the study * Hypercapnic (PaCO2 \> 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician * Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) \> 0.35) * Presence of a tracheostomy or baseline noninvasive ventilation requirement * Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis * Absolute or relative contraindication to BiPAP: facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy
Where this trial is running
Denver, Colorado
- Childrens Hospital Colorado — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Patrick T Wilson, MD — University of Colorado, Denver
- Study coordinator: Patrick T Wilson, MD, MPH
- Email: patrick.t.wilson@cuanschutz.edu
- Phone: 4109632019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.