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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Withdrawn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

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

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

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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