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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774941
• Other study ID #: STU 112015-091
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 8, 2019

Study information

• Verified date: January 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Hospitalized	The primary outcome measure is rate of hospitalization between the two treatment groups overall	Within emergency department visit time frame (no more than 12 hours)
Secondary	Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria		Within emergency department visit time frame (no more than 12 hours)