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

Not Applicable

Withdrawn

• Conditions: Status Asthmaticus
• Interventions: Device: BiPAP treatment

• Registration Number: NCT02539420
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Status Verified: 2016-04
• Study Start: 2016-04
• Primary Completion: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early BiPAP treatment	BiPAP treatment	Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.
Late BiPAP treatment	BiPAP treatment	Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.

Primary Outcome Measures

Name	Time	Method
Clinical Asthma Scores	3 hours after enrollment	Both PRAM and CCMC clinical asthma scores

Secondary Outcome Measures

Name	Time	Method
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
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
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