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Completed

NCT Number: NCT02774941

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

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).

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Medical Center

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jet Nebulizer

Device

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

Vibrating Mesh Nebulizer

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 17, 2016
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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