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Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations (RCT BiPAP)

Primary Purpose

Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIPPV (PALMtop PTV)
Volumetric CO2 (NM3)
USCOM
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Pediatrics, BiPAP, Noninvasive Positive Pressure Ventilation

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 2-18 years old
  • For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
  • For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
  • Acute asthma exacerbation
  • Pediatric Asthma Score (PAS) ≥ 8
  • Parents willing and able to sign consent
  • Children over the age of 6 willing to provide assent

Exclusion Criteria:

  • History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
  • History of sickle cell disease
  • Recently diagnosed pneumonia
  • Current tracheostomy, on home ventilator or home oxygen requirement
  • Recent diabetic ketoacidosis
  • Requiring immediate intubation
  • Weight less than 5 kilograms
  • Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway
  • A history of prematurity of ≤ 30 weeks gestation

Sites / Locations

  • Vanderbilt Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Sham Comparator

Active Comparator

Arm Label

Control

Sham NIPPV

BiPAP

Arm Description

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol.

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.

This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.

Outcomes

Primary Outcome Measures

Change in Pediatric Asthma Score
The primary outcome indicator will be a decrease in PAS to ≤ to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 ≤ in BiPAP group is 5 hours; median expected time to PAS ≤ 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.

Secondary Outcome Measures

Volumetric end tidal CO2 trend
Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors
Respiratory parameters
Analysis of flow loops captured by the NIPPV device, the delta pediatric asthma scores at each time point and changes in individual pulmonary parameters (respiratory rate, oxygen requirement, oxygen saturation).
Cardiac output
Changes in cardiac parameters as measured by the USCOM
Intubation and complication rates
Documentation of intubation rate and possible complications including but not limited to hypotension, vomiting, agitation, skin irritation, pneumothorax, barotrauma effects and death.
Length of hospital stay
Decrease length of hospital stay if placed on NIPPV. This will include looking at the disposition of the subject from the pediatric emergency department.

Full Information

First Posted
December 16, 2011
Last Updated
August 22, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01497691
Brief Title
Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
Acronym
RCT BiPAP
Official Title
A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
unable to recruit participants
Study Start Date
January 2013 (Anticipated)
Primary Completion Date
November 19, 2013 (Actual)
Study Completion Date
November 19, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Pediatrics, BiPAP, Noninvasive Positive Pressure Ventilation

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
Other
Arm Description
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol.
Arm Title
Sham NIPPV
Arm Type
Sham Comparator
Arm Description
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. The pressure settings will be fixed at a positive end-expiratory pressure (PEEP) of 5-8 cm H2O.
Arm Title
BiPAP
Arm Type
Active Comparator
Arm Description
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine. Settings will be adjusted based on the age and clinical presentation of the child.
Intervention Type
Device
Intervention Name(s)
NIPPV (PALMtop PTV)
Intervention Description
PALMtop PTV Models 8/10 aka CareFusion EnVe The primary study device is the PALMtop PTV. It is the NIPPV/BiPAP device used in this study. It is FDA approved for use in children who weigh 5 kilograms or greater (#K070594).
Intervention Type
Device
Intervention Name(s)
Volumetric CO2 (NM3)
Intervention Description
The NM3 is FDA approved (#K091459) for spirometric and carbon dioxide monitoring as well as continuous, non-invasive monitoring of arterial oxygen saturations and pulse rates in neonatal and pediatric patients in the emergency department.
Intervention Type
Device
Intervention Name(s)
USCOM
Intervention Description
The USCOM a non-invasive ultrasonic device that is FDA approved for monitor beat-to-beat cardiac hemodynamics in adult and pediatric patients (#K043139). It will be used in an attempt to better understand the underlying physiology of NIPPV use.
Primary Outcome Measure Information:
Title
Change in Pediatric Asthma Score
Description
The primary outcome indicator will be a decrease in PAS to ≤ to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 ≤ in BiPAP group is 5 hours; median expected time to PAS ≤ 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.
Time Frame
Every 30 minutes while the subject is enrolled
Secondary Outcome Measure Information:
Title
Volumetric end tidal CO2 trend
Description
Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors
Time Frame
Continuous while the subject is enrolled
Title
Respiratory parameters
Description
Analysis of flow loops captured by the NIPPV device, the delta pediatric asthma scores at each time point and changes in individual pulmonary parameters (respiratory rate, oxygen requirement, oxygen saturation).
Time Frame
Continuous while the subject is enrolled
Title
Cardiac output
Description
Changes in cardiac parameters as measured by the USCOM
Time Frame
Continuous while the subject is enrolled
Title
Intubation and complication rates
Description
Documentation of intubation rate and possible complications including but not limited to hypotension, vomiting, agitation, skin irritation, pneumothorax, barotrauma effects and death.
Time Frame
Continuous observation
Title
Length of hospital stay
Description
Decrease length of hospital stay if placed on NIPPV. This will include looking at the disposition of the subject from the pediatric emergency department.
Time Frame
Retrospectively upon completion of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 2-18 years old For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens Acute asthma exacerbation Pediatric Asthma Score (PAS) ≥ 8 Parents willing and able to sign consent Children over the age of 6 willing to provide assent Exclusion Criteria: History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma History of sickle cell disease Recently diagnosed pneumonia Current tracheostomy, on home ventilator or home oxygen requirement Recent diabetic ketoacidosis Requiring immediate intubation Weight less than 5 kilograms Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway A history of prematurity of ≤ 30 weeks gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby M Williams, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

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