Clinical trial NCT02566902: Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Official title: Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2015-10-02
Enrollment: 118
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in FEV1 (% Predicted)
timeFrame: 10 minutes
Secondary outcomes:
measure: Change in PAS Score (Points on a Scale)
timeFrame: 10 minutes
measure: Change in PASS Score (Points on a Scale)
timeFrame: 10 minutes
measure: Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)
timeFrame: Up to 24 hours
measure: Emergency Department Length of Stay (Minutes)
timeFrame: Up to 24 hours
measure: Percentage of Patients Experiencing Medication Side Effects (%)
timeFrame: 10 minutes
measure: Total Quantity of Albuterol Given in the Emergency Department (mg)
timeFrame: up to 24 hours
measure: Change Respiratory Rate (Breaths Per Minute)
timeFrame: 10 minutes
measure: Change in Heart Rate (Beats Per Minute)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center, Emergency Department
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Matthew Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
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