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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774941
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Asthma Device: Jet Nebulizer Device: Vibrating Mesh Nebulizer Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient a Randomized Controlled Trial
Study Start Date : August 2016
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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)


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

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774941


Locations
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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] February 15, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02774941    
Other Study ID Numbers: STU 112015-091
First Posted: May 17, 2016    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases