A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus
Primary Purpose
Status Asthmaticus
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BiPAP treatment
Sponsored by
About this trial
This is an interventional treatment trial for Status Asthmaticus
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Late BiPAP treatment
Early BiPAP treatment
Arm Description
Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation.
Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.
Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.
Outcomes
Primary Outcome Measures
Clinical Asthma Scores
Both PRAM and CCMC clinical asthma scores
Secondary Outcome Measures
Dyspnea Scores
Modified Borg Scale and Wong Baker Faces Scale
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.
Length of stay in intensive care unit (ICU)
Length of stay in hospital
Side effects or adverse events
Clinical Asthma Scores
Full Information
NCT ID
NCT02539420
First Posted
August 26, 2015
Last Updated
April 25, 2016
Sponsor
Northwell Health
Collaborators
Feinstein Institute for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT02539420
Brief Title
A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus
Official Title
A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Feinstein Institute for Medical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Asthmaticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients assigned to the "control" group will receive any treatment for status asthmaticus that does not entail use of positive pressure ventilation.
Arm Title
Late BiPAP treatment
Arm Type
Experimental
Arm Description
Patients assigned to the "late treatment" group will be started on BiPAP greater than 6 hours after randomization.
Arm Title
Early BiPAP treatment
Arm Type
Experimental
Arm Description
Patients assigned to the "early treatment" group will be started on BiPAP as soon as possible after randomization.
Intervention Type
Device
Intervention Name(s)
BiPAP treatment
Intervention Description
Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus
Primary Outcome Measure Information:
Title
Clinical Asthma Scores
Description
Both PRAM and CCMC clinical asthma scores
Time Frame
3 hours after enrollment
Secondary Outcome Measure Information:
Title
Dyspnea Scores
Description
Modified Borg Scale and Wong Baker Faces Scale
Time Frame
0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
Title
BiPAP Tolerance
Description
Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period.
Time Frame
Hospitalization
Title
Length of stay in intensive care unit (ICU)
Time Frame
ICU stay -- Expected to be approximately 3 days on average
Title
Length of stay in hospital
Time Frame
Hospital length of stay -- Expected to be approximately 5 days on average
Title
Side effects or adverse events
Time Frame
Hospitalization
Title
Clinical Asthma Scores
Time Frame
0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Gangadharan, MD
Organizational Affiliation
Cohen Children's Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus
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