Clinical trial NCT01497691: Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Pediatrics
BiPAP
Noninvasive Positive Pressure Ventilation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Pediatric Asthma Score
timeFrame: Every 30 minutes while the subject is enrolled
Secondary outcomes:
measure: Volumetric end tidal CO2 trend
timeFrame: Continuous while the subject is enrolled
measure: Respiratory parameters
timeFrame: Continuous while the subject is enrolled
measure: Cardiac output
timeFrame: Continuous while the subject is enrolled
measure: Intubation and complication rates
timeFrame: Continuous observation
measure: Length of hospital stay
timeFrame: Retrospectively upon completion of study
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Abby M Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: