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

Not Applicable

Terminated

Interventions: Device: Nebulizer (breath-actuated versus conventional continuous-output)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Conventional continuous-ouput nebulizer	Nebulizer (breath-actuated versus conventional continuous-output)	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
Breath-Actuated Nebulizer	Nebulizer (breath-actuated versus conventional continuous-output)	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.

Primary Outcome Measures

Name	Time	Method
Rate of Admission to Hospital for Asthma Exacerbation	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 Outcome Measures

Name	Time	Method
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	Length of stay in the emergency department measured in minutes; up to 400 minutes measured
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)	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.

Locations (1): Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department
🇺🇸
Cleveland, Ohio, United States