Recruiting

BPAP

Sponsor:

Columbia University

Code:

NCT07582211

Conditions

Pediatric Asthma

Acute Asthma

BiPAP

Non-invasive Positive Pressure Ventilation

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Bilevel positive airway pressure ventilation

Study Details

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.

Conditions

Pediatric Asthma

Acute Asthma

BiPAP

Non-invasive Positive Pressure Ventilation

Study ID

NCT07582211

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BPAP plus continuous albuterol

Participants randomized to this arm will receive BPAP plus continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. BPAP will be delivered using an appropriately sized nasal or face mask and managed by trained respiratory therapists and/or nursing staff per standard care. Continuous albuterol will be administered through the BPAP circuit per manufacturer recommendations or site-specific practice. BPAP settings may be adjusted at the discretion of the treating clinician. Participants will remain on BPAP for approximately 2 hours or until continuous albuterol is discontinued, whichever occurs first. After the intervention period, continuation of BPAP will be at the treating clinical team's discretion.

no intervention: Continuous albuterol alone

Participants randomized to this arm will receive continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. Non-invasive ventilation (including BPAP or CPAP) will not be initiated during the first approximately 2 hours after randomization unless clinically indicated; if initiated, the reason will be documented. All other aspects of care, including oxygen and adjunctive therapies, will be provided at the discretion of the treating clinical team per standard practice. After the intervention period, escalation of care, including initiation of BPAP or other respiratory support, will be determined by the treating clinician.

Interventions

Bilevel 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.

Primary outcome measure

  • Number of eligible patients who consent [ Time Frame: From screening through randomization, up to 2 hours ]
  • Proportion of participants who adhere to the BPAP protocol among all those assigned to the BPAP arm [ Time Frame: From randomization through end of 2-hour intervention ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Columbia University

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-18.