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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01045174
• Other study ID #: UH IRB # 09-08-06
• Status: Terminated
• Phase: N/A
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2020
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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.