Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: Jet Nebulizer; Device: Vibrating Mesh Nebulizer

• Registration Number: NCT02774941
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-17
• Study Start: 2016-08
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Status Verified: 2020-01
• Results First Submitted: 2020-01-13
• Results First Submitted QC: 2020-01-21
• Last Update Submitted: 2020-01-21
• Results First Posted: 2020-01-31
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Jet Nebulizer	Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)
Study	Vibrating Mesh Nebulizer	Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Hospitalized	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 Outcome Measures

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

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States