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

This study is currently recruiting participants.
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Abby Williams, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01497691
First received: December 16, 2011
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Device: NIPPV (PALMtop PTV)
Device: Volumetric CO2 (NM3)
Device: USCOM
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in Pediatric Asthma Score [ Time Frame: Every 30 minutes while the subject is enrolled ] [ Designated as safety issue: No ]
    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 [ Time Frame: Continuous while the subject is enrolled ] [ Designated as safety issue: No ]
    Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors

  • Respiratory parameters [ Time Frame: Continuous while the subject is enrolled ] [ Designated as safety issue: No ]
    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 [ Time Frame: Continuous while the subject is enrolled ] [ Designated as safety issue: No ]
    Changes in cardiac parameters as measured by the USCOM

  • Intubation and complication rates [ Time Frame: Continuous observation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Retrospectively upon completion of study ] [ Designated as safety issue: No ]
    Decrease length of hospital stay if placed on NIPPV. This will include looking at the disposition of the subject from the pediatric emergency department.


Estimated Enrollment: 441
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol.
 Device: USCOM
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.
Sham Comparator: Sham NIPPV
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.
 Device: NIPPV (PALMtop PTV)
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).
Device: Volumetric CO2 (NM3)
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.
Device: USCOM
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.
Active Comparator: BiPAP
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.
 Device: NIPPV (PALMtop PTV)
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).
Device: Volumetric CO2 (NM3)
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.
Device: USCOM
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497691

Contacts
Contact: Abby M Williams, MD 615-936-3898 abby.m.williams@vanderbilt.edu
Contact: Thomas J Abramo, MD 615-936-3898 thomas.j.abramo@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Children's Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Abby M Williams, MD         abby.m.williams@vanderbilt.edu    
Principal Investigator: Abby M Williams, MD            
Sub-Investigator: Thomas J Abramo, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Abby M Williams, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Abby Williams, Clinical Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01497691     History of Changes
Other Study ID Numbers: 111491
Study First Received: December 16, 2011
Last Updated: January 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Asthma
Pediatrics
BiPAP
Noninvasive Positive Pressure Ventilation

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013