BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

Last updated: October 2, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

Bi-level Positive Airway Pressure

Sham Bi-level Positive Airway Pressure

Clinical Study ID

NCT05848115
22-2338
1R61HL158814-01A1
  • Ages 5-17
  • All Genders

Study Summary

The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are:

  1. Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy.

  2. Whether early BiPAP changes how the lungs function in children with asthma attacks.

  3. Whether children receiving early BiPAP experience more issues or side effects than those children who do not.

All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team.

Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.

Eligibility Criteria

Inclusion

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 forcontinuous beta-agonist therapy after first-line therapy

Exclusion

Exclusion Criteria:

  • Prior participation in the study

  • Hypercapnic (PaCO2 > 60 mmHg) respiratory failure or need for invasive mechanicalventilation as determined by the treating physician

  • Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen inspiredoxygen 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, uncontrollablevomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness orconfusion, known or clinical suspicion for pneumothorax, pneumomediastinum, orsubcutaneous emphysema, pregnancy

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Bi-level Positive Airway Pressure
Phase:
Study Start date:
June 23, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Childrens Hospital Colorado

    Denver, Colorado 80238
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.