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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients

NCT01045174

Asthma

TERMINATED NA

Salbutamol in the Pediatric Emergencies: Nebulization Estimated Via AerogeN or Jet

NCT03042065

Asthma

UNKNOWN NA

Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

NCT01497691

Asthma

WITHDRAWN NA

Comparison of Nebulizers in ED in Pediatric Asthma Patients

NCT01951378

Asthma

TERMINATED PHASE4

BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

NCT05848115

Asthma in Children

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type ACTIVE_COMPARATOR

Jet Nebulizer

Intervention Type DEVICE

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

Study

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

Group Type EXPERIMENTAL

Vibrating Mesh Nebulizer

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Jet Nebulizer

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

Intervention Type DEVICE

Vibrating Mesh Nebulizer

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes