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

NCT01497691 | Withdrawn DMC

• 1 other identifier: 111491
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Pediatrics; BiPAP; Noninvasive Positive Pressure Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Volumetric end tidal CO2 trend

  Continuous while the subject is enrolled

• Respiratory parameters

  Continuous while the subject is enrolled

• Cardiac output

  Continuous while the subject is enrolled

• Intubation and complication rates

  Continuous observation

• Length of hospital stay

  Retrospectively upon completion of study

Study Arms (3)

Control

OTHER

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

Device: USCOM

Sham NIPPV

SHAM COMPARATOR

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); Device: Volumetric CO2 (NM3); Device: USCOM

BiPAP

ACTIVE COMPARATOR

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); Device: Volumetric CO2 (NM3); Device: USCOM

Interventions

NIPPV (PALMtop PTV) DEVICE

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).

BiPAP; Sham NIPPV

Volumetric CO2 (NM3) DEVICE

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.

BiPAP; Sham NIPPV

USCOM DEVICE

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.

BiPAP; Control; Sham NIPPV

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Abby M Williams, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 22, 2011
• Study Start: January 1, 2013
• Primary Completion: November 19, 2013
• Study Completion: November 19, 2013
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)