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

A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus

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.

Study Overview

• Status: Withdrawn
• Conditions: Status Asthmaticus
• Intervention / Treatment: Device: BiPAP treatment

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation.
Experimental: Late BiPAP treatment; Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.	Device: BiPAP treatment; Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus
Experimental: Early BiPAP treatment; Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.	Device: BiPAP treatment; Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Asthma Scores	Both PRAM and CCMC clinical asthma scores	3 hours after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea Scores	Modified Borg Scale and Wong Baker Faces Scale	0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
BiPAP Tolerance	Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period.	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
Clinical Asthma Scores		0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Feinstein Institute for Medical Research
• Investigators: Principal Investigator: Sandeep Gangadharan, MD, Cohen Children's Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Status Asthmaticus
• Other Study ID Numbers: 14-245