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

A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Device: USCOM; Device: NIPPV (PALMtop PTV); Device: Volumetric CO2 (NM3)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: 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.; 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.
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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every 30 minutes while the subject is enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric end tidal CO2 trend	Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors	Continuous while the subject is enrolled
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).	Continuous while the subject is enrolled
Cardiac output	Changes in cardiac parameters as measured by the USCOM	Continuous while the subject is enrolled
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.	Continuous observation
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.	Retrospectively upon completion of study

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Abby M Williams, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2013
• Primary Completion (Actual): November 19, 2013
• Study Completion (Actual): November 19, 2013

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 22, 2011

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Asthma; Pediatrics; BiPAP; Noninvasive Positive Pressure Ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Emergencies; Asthma
• Other Study ID Numbers: 111491

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No