Expired Study
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Austin, Texas 78723


Purpose:

This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.


Study summary:

The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.


Criteria:

Inclusion Criteria: - Age ≥ 6 years and < 18 years - History of physician diagnosed asthma - Presenting to ED with breathing difficulty or cough - Initial FEV1 25%-70% predicted - Parent or guardian speaks English or Spanish. Exclusion Criteria: - Pediatric Asthma Score of 0 - Pregnancy or breast-feeding - Immediate resuscitation required - Chronic lung disease (other than asthma) - Congenital heart disease - Neuromuscular disease - Suspected intrathoracic foreign body - Allergy or other contraindication to study medication


NCT ID:

NCT02566902


Primary Contact:

Principal Investigator
Matthew Wilkinson, MD
Seton Healthcare Family


Backup Contact:

N/A


Location Contact:

Austin, Texas 78723
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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