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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Withdrawn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
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Asthmaticus

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 26, 2015
    Last Updated
    April 25, 2016
    Sponsor
    Northwell Health
    Collaborators
    Feinstein Institute for Medical Research
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    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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