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

Primary Purpose

Asthma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nebulizer (breath-actuated versus conventional continuous-output)
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Pediatric, Emergency department, Nebulizer

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Breath-Actuated Nebulizer

Conventional continuous-ouput nebulizer

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device

Full Information

First Posted
January 7, 2010
Last Updated
November 23, 2020
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01045174
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
change in availability of study investigators
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Pediatric, Emergency department, Nebulizer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breath-Actuated Nebulizer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional continuous-ouput nebulizer
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Nebulizer (breath-actuated versus conventional continuous-output)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Admission to Hospital for Asthma Exacerbation
Description
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)
Time Frame
24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Secondary Outcome Measure Information:
Title
Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation
Description
Length of stay in the emergency department measured in minutes; up to 400 minutes measured
Time Frame
only measures length of stay in emergency department on date of presentation
Title
Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)
Description
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.
Time Frame
within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
Title
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerri A Rose, M.D.
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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