Clinical trial NCT01045174: Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Pediatric
Emergency department
Nebulizer
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of Admission to Hospital for Asthma Exacerbation
timeFrame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Secondary outcomes:
measure: Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation
timeFrame: only measures length of stay in emergency department on date of presentation
measure: Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)
timeFrame: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
measure: Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
timeFrame: 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.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jerri A Rose, M.D.
role: PRINCIPAL_INVESTIGATOR
References: