A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus

Study Overview
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Brief Summary
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Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.

Official Title
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A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus

Conditions
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Status Asthmaticus

Intervention / Treatment
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* Device: BiPAP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of asthma exacerbation Admitted to Cohen Children's Medical Center (CCMC) PICU CCMC respiratory severity score of 6 or higher at the time of enrollment Prior history of asthma or reactive airway disease Exclusion Criteria: No prior history of asthma or reactive airway disease Facial or airway anomalies precluding BiPAP mask use Tracheostomy Lack of airway protective reflexes Neurologic or musculoskeletal abnormalities affecting respiration Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| No Intervention: Control<br>Patients assigned to the control group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation. | |
| Experimental: Late BiPAP treatment<br>Patients assigned to the late treatment group will be started on BiPAP greater than 6 hours after randomization. | Device: BiPAP treatment<br>* Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus<br>|
| Experimental: Early BiPAP treatment<br>Patients assigned to the early treatment group will be started on BiPAP as soon as possible after randomization. | Device: BiPAP treatment<br>* Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Asthma Scores | Both PRAM and CCMC clinical asthma scores | 3 hours after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea Scores | Modified Borg Scale and Wong Baker Faces Scale | 0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment | 
| BiPAP Tolerance | Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period. | Hospitalization | 
| Length of stay in intensive care unit (ICU) |  | ICU stay -- Expected to be approximately 3 days on average | 
| Length of stay in hospital |  | Hospital length of stay -- Expected to be approximately 5 days on average | 
| Side effects or adverse events |  | Hospitalization | 
| Clinical Asthma Scores |  | 0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment |