Status:
WITHDRAWN
Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Asthma
Eligibility:
All Genders
2-18 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01497691
Start Date
January 1 2013
End Date
November 19 2013
Last Update
August 24 2017
Active Locations (1)
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1
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232