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

Northwell Health

Status: Withdrawn

Conditions: Status Asthmaticus

Treatments: Device: BiPAP treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02539420

14-245

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.

Treatment:

Device: BiPAP treatment

Early BiPAP treatment

Experimental group

Description:

Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.

Treatment:

Device: BiPAP treatment