Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
Overview
- Phase
- Not Applicable
- Intervention
- T-Piece Nebulizer
- Conditions
- Asthma
- Sponsor
- Seton Healthcare Family
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change in FEV1 (% Predicted)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
Detailed Description
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 6 years and \< 18 years
- •History of physician diagnosed asthma
- •Presenting to ED with breathing difficulty or cough
- •Initial FEV1 25%-70% predicted
- •Parent or guardian speaks English or Spanish.
Exclusion Criteria
- •Pediatric Asthma Score of 0
- •Pregnancy or breast-feeding
- •Immediate resuscitation required
- •Chronic lung disease (other than asthma)
- •Congenital heart disease
- •Neuromuscular disease
- •Suspected intrathoracic foreign body
- •Allergy or other contraindication to study medication
Arms & Interventions
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: T-Piece Nebulizer
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Albuterol
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Pre-Treatment Spirometry Measurement
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Post-Treatment Spirometry Measurement
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Breath-Enhanced Nebulizer
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Albuterol
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Pre-Treatment Spirometry Measurement
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
Intervention: Post-Treatment Spirometry Measurement
Outcomes
Primary Outcomes
Change in FEV1 (% Predicted)
Time Frame: 10 minutes
Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1
Secondary Outcomes
- Emergency Department Length of Stay (Minutes)(Up to 24 hours)
- Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)(Up to 24 hours)
- Change in PASS Score (Points on a Scale)(10 minutes)
- Change Respiratory Rate (Breaths Per Minute)(10 minutes)
- Change in PAS Score (Points on a Scale)(10 minutes)
- Percentage of Patients Experiencing Medication Side Effects (%)(10 minutes)
- Change in Heart Rate (Beats Per Minute)(10 minutes)
- Total Quantity of Albuterol Given in the Emergency Department (mg)(up to 24 hours)