BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

Not Applicable

Recruiting

• Conditions: Asthma in Children
• Interventions: Device: Bi-level Positive Airway Pressure; Device: Sham Bi-level Positive Airway Pressure

• Registration Number: NCT05848115
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-08
• Study Start: 2023-06-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiPAP	Bi-level Positive Airway Pressure	Patients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician.
Control	Sham Bi-level Positive Airway Pressure	Patients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician.

Primary Outcome Measures

Name	Time	Method
Duration of Continuous Beta-Agonist Therapy	Through study completion, an average of 24 hours	Number of hours until discontinuation of continuous beta-agonist therapy

Secondary Outcome Measures

Name	Time	Method
Hospital Readmissions	7 days from hospital discharge date	Rate of hospital readmission within 7 days
Duration of Bilevel Positive Airway Pressure (BiPAP)	Through entire hospitalization, an average of 72 hours	Duration in hours of BiPAP administration
Change in Pulse Oxygen Saturation	At 2 hour and 4 hours after starting the intervention	Change in pulse oxygen saturation (range from 0 to 100%) from baseline to two and four hours
Change in Pediatric Respiratory Assessment Measure (PRAM)	At two and four hours after starting the intervention	Change in Pediatric Respiratory Assessment Measure (PRAM) from baseline to two and four hours, minimum score of 0 and maximum score of 12, the higher the score the more severe the disease
Total Length of Stay in Hospital	Through entire hospitalization, an average of 72 hours	Total length of stay in hours in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), and hospital floor
Change in Heart Rate	At 2 hour and 4 hours after starting the intervention	Change in heart rate in beats per minute from baseline to two and four hours
Change in Respiratory Rate	At two and four hours after starting the intervention	Change in respiratory rate in breaths per minute from baseline to two and four hours
Invasive Mechanical Ventilation	Four-hour study intervention	Rate of participants requiring endotracheal intubation for invasive mechanical ventilation
Admission to Pediatric Intensive Care Unit (PICU)	Through entire hospitalization, an average of 72 hours	Rate of admissions to the Pediatric Intensive Care Unit (PICU)
Adverse Events	Four-hour study intervention	Pneumothorax, pneumomediastinum, sub-cutaneous emphysema, hypotension, vomiting, aspiration, skin breakdown

Trial Locations

Locations (1)

Childrens Hospital Colorado; 🇺🇸 Denver, Colorado, United States