Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Number of Subjects Hospitalized
Study Overview
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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria(Within emergency department visit time frame (no more than 12 hours))