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

University of Texas Southwestern Medical Center220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Asthma

Interventions

Jet NebulizerDEVICE

Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)

Vibrating Mesh NebulizerDEVICE

Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Number of Subjects Hospitalized

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

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

Secondary Outcomes

Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria

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

Data from ClinicalTrials.gov

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