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

January 21, 2020 updated by: University of Texas Southwestern Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within emergency department visit time frame (no more than 12 hours)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

March 8, 2019

Study Completion (ACTUAL)

March 8, 2019

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (ESTIMATE)

May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 112015-091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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