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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Device: Nebulizer (breath-actuated versus conventional continuous-output)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breath-Actuated Nebulizer<br>Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. | Device: Nebulizer (breath-actuated versus conventional continuous-output)<br>* Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.<br>|
| Active Comparator: Conventional continuous-ouput nebulizer<br>Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer | Device: Nebulizer (breath-actuated versus conventional continuous-output)<br>* Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Admission to Hospital for Asthma Exacerbation | 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) | 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation | Length of stay in the emergency department measured in minutes; up to 400 minutes measured | only measures length of stay in emergency department on date of presentation | 
| Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey) | Percentage of patients (or caregivers of younger children) who agreed or strongly agreed on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree. | within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED) | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nebulizer, Asthma, Pediatric, Emergency department