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

Purpose

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.

Condition	Intervention
Asthma	Device: Nebulizer (breath-actuated versus conventional continuous-output)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Rate of admission to hospital for asthma exacerbation [ Time Frame: hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of stay in the emergency department after presenting for asthma exacerbation [ Time Frame: only measures length of stay in emergency department on date of presentation ] [ Designated as safety issue: No ]
Number of aerosolized bronchodilator treatments required during emergency department course [ Time Frame: during emergency department visit on day of presentation ] [ Designated as safety issue: No ]
patient's satisfaction with using assigned nebulizer (as assessed by brief survey) [ Time Frame: within time frame of emergency department stay ] [ Designated as safety issue: No ]
difficulty (if any) encountered by patients with using assigned nebulizer device [ Time Frame: hours (during patient's emergency department course) ] [ Designated as safety issue: No ]

Enrollment:	190
Study Start Date:	December 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	1 Year to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045174

Locations

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

Sponsors and Collaborators

University Hospitals of Cleveland

Investigators

Principal Investigator:

Jerri A Rose, M.D.

University Hospitals of Cleveland

More Information

No publications provided

Responsible Party:	Jerri A. Rose, M.D., University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT01045174 History of Changes
Other Study ID Numbers:	UH IRB # 09-08-06
Study First Received:	January 7, 2010
Last Updated:	June 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Asthma
Pediatric
Emergency department
Nebulizer

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013