Clinical trial NCT05848115: BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial
Official title: Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Pediatric Asthma
Asthma
Bi-level Positive Airway Pressure
BiPAP
Beta-Agonist
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-08
Enrollment: 126
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Duration of Continuous Beta-Agonist Therapy
timeFrame: Through study completion, an average of 24 hours
Secondary outcomes:
measure: Change in Pediatric Respiratory Assessment Measure (PRAM)
timeFrame: At two and four hours after starting the intervention
measure: Change in Respiratory Rate
timeFrame: At two and four hours after starting the intervention
measure: Invasive Mechanical Ventilation
timeFrame: Four-hour study intervention
measure: Admission to Pediatric Intensive Care Unit (PICU)
timeFrame: Through entire hospitalization, an average of 72 hours
measure: Total Length of Stay in Hospital
timeFrame: Through entire hospitalization, an average of 72 hours
measure: Hospital Readmissions
timeFrame: 7 days from hospital discharge date
measure: Duration of Bilevel Positive Airway Pressure (BiPAP)
timeFrame: Through entire hospitalization, an average of 72 hours
measure: Adverse Events
timeFrame: Four-hour study intervention
measure: Change in Pulse Oxygen Saturation
timeFrame: At 2 hour and 4 hours after starting the intervention
measure: Change in Heart Rate
timeFrame: At 2 hour and 4 hours after starting the intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Patrick T Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: