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| Name | Class |
|---|---|
| Feinstein Institute for Medical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation. | |
| Late BiPAP treatment | Experimental | Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization. |
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| Early BiPAP treatment | Experimental | Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP treatment | Device | Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Asthma Scores | Both PRAM and CCMC clinical asthma scores | 3 hours after enrollment |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Gangadharan, MD | Cohen Children's Medical Center | Principal Investigator |
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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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| 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 |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |