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

NCT01045174 | Terminated Results

• 1 other identifier: UH IRB # 09-08-06
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Pediatric; Emergency department; Nebulizer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation

  only measures length of stay in emergency department on date of presentation

• 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)

• 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.

Study Arms (2)

Breath-Actuated Nebulizer

ACTIVE COMPARATOR

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)

Conventional continuous-ouput nebulizer

ACTIVE COMPARATOR

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)

Interventions

Nebulizer (breath-actuated versus conventional continuous-output) DEVICE

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.

Breath-Actuated Nebulizer; Conventional continuous-ouput nebulizer

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Asthma; Emergencies

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Dr. Jerri Rose
• Organization: University Hospitals Cleveland Medical Center

jerri.rose@uhhospitals.org

216-844-7147

Study Officials

• Jerri A Rose, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 25, 2020
• Results First Posted: November 25, 2020

Record last verified: 2020-11

Locations

US (1)