Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma Exacerbations: A Randomized Controlled Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests early BPAP, a machine that helps breathing through a face mask, for children ages 5–17 with severe asthma attacks in the emergency department. It compares BPAP plus usual asthma care with usual care alone. Researchers will check whether this approach is practical, safe, and may help children recover.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 5–17 and visiting the emergency department for an asthma attack.
- Have a moderate to severe asthma attack at the first check, based on the hospital’s asthma score or a PRAM breathing score of at least 6.
Who can't join
- Have already joined this study, or used BPAP for this attack within about 12 hours before being assigned a study treatment.
- Have received nonstop albuterol, a medicine that opens the airways, for more than 150 minutes before being asked to join. Also excluded if the latest blood gas test shows carbon dioxide above 60 mmHg; this test is not required.
- The doctor expects a need for a breathing tube or breathing machine within about an hour after the first treatments; have a breathing opening in the neck called a tracheostomy; or normally need breathing support through a mask.
- Have wheezing caused by something other than asthma, or another health condition that could make the study unsafe, hard to complete, or affect the results.
- Have an injury where the BPAP mask fits, more than 3 vomiting episodes in about an hour before being asked to join, very low blood pressure for age, a score of 8 or less on a test of alertness, or a known or suspected air leak outside the lungs.
- Weigh less than 20 kg (about 44 pounds), have a mass or fluid buildup in the belly pressing on the stomach, or are known or suspected to be pregnant.
- Have a PRAM breathing score below 7 or above 10 after the first usual treatments. These treatments include at least 3 inhaled albuterol doses or at least 1 hour of nonstop albuterol, plus steroid medicine to reduce swelling.
- Do not need nonstop albuterol or a second round of albuterol treatments after the first usual treatments.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (3)
NY
- Columbia University Irving Medical Center · New York, NY 10032Maria Kwok, MD, MPH · Study contact · 917-375-2647 · myk2102@cumc.columbia.eduMore trials in New York
OH
- Nationwide Children's Hospital · Columbus, OH 43205Adjoa Andoh, MD · Study contact · 614-355-3713 · adjoa.andoh@nationwidechildrens.orgMore trials in Columbus
PA
- Children's Hospital of Philadelphia · Philadelphia, PA 19104Joe Zorc, MD, MSCE · Study contact · 215-590-5237 · zorc@chop.eduMore trials in Philadelphia