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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy (Control) | Other | Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
|
| Standard Therapy plus BPAP | Experimental | Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips Respironics V60 Non-invasive ventilator, BPAP | Device | Continuous albuterol will be administered through the BPAP circuit. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of Adverse Events | 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. | Until hospital discharge, approximately 2 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick T Wilson, MD | Columbia University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356050 | Derived | Korang SK, Baker M, Feinberg J, Newth CJ, Khemani RG, Jakobsen JC. Non-invasive positive pressure ventilation for acute asthma in children. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD012067. doi: 10.1002/14651858.CD012067.pub3. |
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| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Therapy | Other | Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
|
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 |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |