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

NCT02539420 | Withdrawn DMC

• 1 other identifier: 14-245
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Clinical Asthma Scores

  Both PRAM and CCMC clinical asthma scores

  3 hours after enrollment

Secondary Outcomes (6)

• Dyspnea Scores

  0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment

• BiPAP Tolerance

  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

Study Arms (3)

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.

Device: BiPAP treatment

Early BiPAP treatment

EXPERIMENTAL

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

Device: BiPAP treatment

Interventions

BiPAP treatment DEVICE

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

Early BiPAP treatment; Late BiPAP treatment

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Feinstein Institute for Medical Research: collaborator

MeSH Terms

Conditions

Status Asthmaticus

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sandeep Gangadharan, MD

  Cohen Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 3, 2015
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04