BPAP in Pediatric Asthma Pilot Study
Study Details
Study Description
Brief Summary
The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations. The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Standard Therapy (Control) Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
Other: Standard Therapy
Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
|
| Experimental: Standard Therapy plus BPAP Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
Device: Philips Respironics V60 Non-invasive ventilator, BPAP
Continuous albuterol will be administered through the BPAP circuit.
Other Names:
Other: Standard Therapy
Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
|
Outcome Measures
Primary Outcome Measures
- Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year. [One year]
Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department.
Secondary Outcome Measures
- Difference in PRAM Score [At 2 and 4 hour time points]
Difference in PRAM scores at 2 and 4 hours. PRAM scores range from 0 to 12 with a score of 4 or greater indicating moderate to severe disease. Decreasing scores reflect clinical improvement in response to therapy.
- Difference in Respiratory Rate [At 2 and 4 hour time points]
Difference in respiratory rate measured in breaths per minute (bpm).
- Difference in Oxygen Saturation [At 2 and 4 hour time points]
Difference in percent oxygen saturation.
- Difference in Heart Rate [At 2 and 4 hour time points]
Difference in heart rate measured in beats per minute (bpm).
- Difference in Systolic and Diastolic Blood Pressure [At 2 and 4 hour time points]
Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
- Difference in Duration of continuous beta-agonist therapy [Until therapy is completed, approximately 24 hours]
Difference in duration of continuous beta-agonist therapy measured in hours.
- Rate of PICU Admission [Until hospital discharge, approximately 2 days]
Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor
- Length of Stay [Until hospital discharge, approximately 2 days]
Length of stay, measured in days, in the ED, PICU, or hospital
Other Outcome Measures
- Cumulative Number of Adverse Events [Until hospital discharge, approximately 2 days]
The total number of adverse events per arm will be reported. Adverse events include air leak syndrome, aspiration pneumonia, skin break down, hypotension, intubation, death or other adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation
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Prior clinician diagnosis of asthma
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PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen
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Need for continuous nebulized albuterol therapy
Exclusion Criteria:
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Hypercapneic respiratory failure (partial pressure of carbon dioxide > 60 mmHg)
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Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen > 0.35)
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Presence of a tracheostomy or baseline noninvasive ventilation requirement
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Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis)
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Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight < 20kg)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Patrick T Wilson, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAS8758