A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Continuous albuterol has become the standard of care for patients in status asthmaticus. We have previously performed an in-vitro study comparing 4 different brands of continuous nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we use. we hypothesize that there will be no difference between in-vivo and in-vitro results.

Study Overview

• Status: Unknown
• Conditions: Asthma

Detailed Description

There will be no intervention to the patients. Nebulizers will be used as per current policies and procedures. They will only be marked on the outside at the water level every 2 hours for the first 6 hours. Once ready to be discarded will be collected for laboratory testing Once in the laboratory, nebulizers will be weight on a precision scale without liquid, then they will be filled with normal saline to the first mark (6th hour) and re-weight. The nebulizers will be filled to next mark and re-weight until 200 mls. of total volume are achieved. Solution output will be calculated as the weight difference between the 2 hour periods.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ariel Berlinski, M.D.; Phone Number: 501-364-1006; Email: berlinskiariel@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Hospital
      • Contact: Ariel Berlinski, M.D.; Phone Number: 501-364-1006; Email: berlinskiariel@uams.edu
      • Principal Investigator: Ariel Berlinski, M.D.
      • Sub-Investigator: Randy Willis, R.R.T.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the Pediatric Intensive Care Unit due to status asthmaticus, requiring continuous albuterol nebulization.

Description

Inclusion Criteria:

• Pediatric patients admitted to Pediatric Intensive Care Unit due to status asthmaticus, requiring continuous albuterol nebulization.

Exclusion Criteria:

• Patients requiring invasive or non-invasive ventilation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nebulizer solution output	every 2 hours for first 6 hours

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: S&T Medical Technologies, Inc.
• Investigators: Principal Investigator: Ariel Berlinski, M.D., University of Arkansas

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: February 29, 2008
• First Posted (Estimate): March 10, 2008

Study Record Updates

• Last Update Posted (Estimate): June 5, 2009
• Last Update Submitted That Met QC Criteria: June 3, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: large volume nebulizer
• Other Study ID Numbers: 98551