Status Asthmaticus
Conditions
Brief summary
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.
Interventions
DEVICEBiPAP treatment
Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus
Sponsors
Feinstein Institute for Medical Research
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Asthma Scores | 3 hours after enrollment | Both PRAM and CCMC clinical asthma scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BiPAP Tolerance | Hospitalization | Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period. |
| Length of stay in intensive care unit (ICU) | ICU stay -- Expected to be approximately 3 days on average | — |
| Dyspnea Scores | 0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment | Modified Borg Scale and Wong Baker Faces Scale |
| Side effects or adverse events | Hospitalization | — |
| Clinical Asthma Scores | 0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment | — |
| Length of stay in hospital | Hospital length of stay -- Expected to be approximately 5 days on average | — |
Outcome results
None listed