A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Rate of Admission to Hospital for Asthma Exacerbation
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.
Investigators
Jerri A. Rose
M.D.
University Hospitals Cleveland Medical Center
Eligibility Criteria
Inclusion Criteria
- •children 1-17 years old with known history of asthma
- •children must be presenting to the emergency department for treatment of acute asthma
- •children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm
Exclusion Criteria
- •concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
- •no prior history of asthma
- •pregnancy
- •reported history of drug allergy to albuterol or ipratropium bromide
- •previous participation in the study within the preceding three weeks
- •vital sign instability/need for immediate emergency intervention to prevent clinical deterioration
Outcomes
Primary Outcomes
Rate of Admission to Hospital for Asthma Exacerbation
Time Frame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)
Secondary Outcomes
- Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device(number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.)
- Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation(only measures length of stay in emergency department on date of presentation)
- Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)(within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED))