BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

Asthma in Children Clinical Trial

Official title:

Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848115
• Other study ID #: 22-2338
• Secondary ID: 1R61HL158814-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: January 2027

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: Patrick T Wilson, MD, MPH
• Phone: 4109632019
• Email: patrick.t.wilson[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: January 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• Bi-level Positive Airway Pressure
An appropriately sized vented BiPAP face mask with a good seal will be applied and monitored by trained respiratory therapists. Patients will be started on an inspiratory peak airway pressure (IPAP) of 10 cm of water and expiratory positive airway pressure (EPAP) of 5 cm of water per Children's Hospital Colorado (CHCO) clinical pathway. BiPAP pressures will be titrated to effect per the treating physician, using assessment of physical examination, vitals, and asthma score per institutional clinical pathway. Study participants will remain on BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the ongoing use of BiPAP or not.
• Sham Bi-level Positive Airway Pressure
The sham BiPAP will have pressure attenuated using an orifice restrictor as described in previous double blinded studies using sham non-invasive ventilation. With this set-up pressures no greater than 2 cm of water have been documented at the location of the face mask. This will ensure that the patient is not receiving positive pressure with any effectiveness or deleterious effects. Study participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the use of BiPAP or not.

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Continuous Beta-Agonist Therapy	Number of hours until discontinuation of continuous beta-agonist therapy	Through study completion, an average of 24 hours
Secondary	Change in Pediatric Respiratory Assessment Measure (PRAM)	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	At two and four hours after starting the intervention
Secondary	Change in Respiratory Rate	Change in respiratory rate in breaths per minute from baseline to two and four hours	At two and four hours after starting the intervention
Secondary	Invasive Mechanical Ventilation	Rate of participants requiring endotracheal intubation for invasive mechanical ventilation	Four-hour study intervention
Secondary	Admission to Pediatric Intensive Care Unit (PICU)	Rate of admissions to the Pediatric Intensive Care Unit (PICU)	Through entire hospitalization, an average of 72 hours
Secondary	Total Length of Stay in Hospital	Total length of stay in hours in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), and hospital floor	Through entire hospitalization, an average of 72 hours
Secondary	Hospital Readmissions	Rate of hospital readmission within 7 days	7 days from hospital discharge date
Secondary	Duration of Bilevel Positive Airway Pressure (BiPAP)	Duration in hours of BiPAP administration	Through entire hospitalization, an average of 72 hours
Secondary	Adverse Events	Pneumothorax, pneumomediastinum, sub-cutaneous emphysema, hypotension, vomiting, aspiration, skin breakdown	Four-hour study intervention
Secondary	Change in Pulse Oxygen Saturation	Change in pulse oxygen saturation (range from 0 to 100%) from baseline to two and four hours	At 2 hour and 4 hours after starting the intervention
Secondary	Change in Heart Rate	Change in heart rate in beats per minute from baseline to two and four hours	At 2 hour and 4 hours after starting the intervention