BPAP in Pediatric Asthma Pilot Study

Study Overview
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Brief Summary
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The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.

Detailed Description
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Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP). 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.

Official Title
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Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study

Conditions
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Asthma in Children, Status Asthmaticus

Intervention / Treatment
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* Device: Philips Respironics V60 Non-invasive ventilator, BPAP
* Other: Standard Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation Prior clinician diagnosis of asthma PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen Need for continuous nebulized albuterol therapy Exclusion Criteria: Hypercapneic respiratory failure (partial pressure of carbon dioxide > 60 mmHg) Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen > 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) 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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Therapy (Control)<br>Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. | Other: Standard Therapy<br>* Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.<br>|
| Experimental: Standard Therapy plus BPAP<br>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<br>* Continuous albuterol will be administered through the BPAP circuit.<br>* Other names: Philips Respironics V60 Non-invasive ventilator;Other: Standard Therapy<br>* Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year. | Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in PRAM Score | 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. | At 2 and 4 hour time points | 
| Difference in Respiratory Rate | Difference in respiratory rate measured in breaths per minute (bpm). | At 2 and 4 hour time points | 
| Difference in Oxygen Saturation | Difference in percent oxygen saturation. | At 2 and 4 hour time points | 
| Difference in Heart Rate | Difference in heart rate measured in beats per minute (bpm). | At 2 and 4 hour time points | 
| Difference in Systolic and Diastolic Blood Pressure | Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg). | At 2 and 4 hour time points | 
| Difference in Duration of continuous beta-agonist therapy | Difference in duration of continuous beta-agonist therapy measured in hours. | Until therapy is completed, approximately 24 hours | 
| Rate of PICU Admission | Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor | Until hospital discharge, approximately 2 days | 
| Length of Stay | Length of stay, measured in days, in the ED, PICU, or hospital | Until hospital discharge, approximately 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive ventilation, BPAP, continous albuterol, pediatrics