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

NCT ID: NCT02539420

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30

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.

Conditions

Status Asthmaticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Late BiPAP treatment

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

Group Type: EXPERIMENTAL

BiPAP treatment

Intervention Type: DEVICE

Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus

Early BiPAP treatment

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

Group Type: EXPERIMENTAL

BiPAP treatment

Intervention Type: DEVICE

Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus

Interventions

BiPAP treatment

Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Feinstein Institute for Medical Research

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Gangadharan

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandeep Gangadharan, MD

Role: PRINCIPAL_INVESTIGATOR

Cohen Children's Medical Center

Other Identifiers

14-245

Identifier Type: -

Identifier Source: org_study_id