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

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

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Device: Nebulizer (breath-actuated versus conventional continuous-output)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breath-Actuated Nebulizer; 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); 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.
Active Comparator: Conventional continuous-ouput nebulizer; 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); 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Jerri A Rose, M.D., University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 8, 2010

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; Pediatric; Emergency department; Nebulizer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: UH IRB # 09-08-06