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Clinical Trials/NCT02774941
NCT02774941
Completed
Not Applicable

Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient a Randomized Controlled Trial

University of Texas Southwestern Medical Center1 site in 1 country220 target enrollmentAugust 2016
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Texas Southwestern Medical Center
Enrollment
220
Locations
1
Primary Endpoint
Number of Subjects Hospitalized
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).

Detailed Description

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital admissions and decrease length of stay in CMCED when compared to the current practice of using a JN and AM or MP.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
March 8, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 2 to 18 year old (up to 19th birthday) otherwise healthy children with primary diagnosis of acute moderate to severe exacerbation of asthma presenting to Children's Medical Center Emergency Department, Dallas

Exclusion Criteria

  • Children \< 2 years old
  • Children with comorbid/complex medical conditions such as: congenital or acquired cardiovascular disease, cystic fibrosis, chronic lung disease (other than asthma), bronchopulmonary dysplasia, airway anomalies (e.g., tracheomalacia) or immunodeficiency syndromes.
  • Patients with coexisting medical condition such as pneumonia
  • Patients in impending respiratory failure as determined by treating physician
  • Patients that have had oral corticosteroids within 24hrs of CMCED admission
  • Patients that have had bronchodilator treatment within one hour of CMCED admission

Outcomes

Primary Outcomes

Number of Subjects Hospitalized

Time Frame: Within emergency department visit time frame (no more than 12 hours)

The primary outcome measure is rate of hospitalization between the two treatment groups overall

Secondary Outcomes

  • Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria(Within emergency department visit time frame (no more than 12 hours))

Study Sites (1)

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