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

This study is currently recruiting participants.

Verified by Arkansas Children's Hospital Research Institute, June 2009

First Received: February 29, 2008 Last Updated: June 3, 2009 History of Changes

Sponsors and Collaborators:	Arkansas Children's Hospital Research Institute S&T Medical Technologies Inc
Information provided by:	Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00632112

Purpose

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.

Condition
Asthma

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:

Nebulizer solution output [ Time Frame: every 2 hours for first 6 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632112

Contacts

Contact: Ariel Berlinski, M.D.

501-364-1006

berlinskiariel@uams.edu

Locations

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

Sponsors and Collaborators

Arkansas Children's Hospital Research Institute

S&T Medical Technologies Inc

Investigators

Principal Investigator:

Ariel Berlinski, M.D.

University of Arkansas

More Information

No publications provided

Responsible Party:	University of Arkansas for Medical Sciences ( Ariel Berlinski )
Study ID Numbers:	98551
Study First Received:	February 29, 2008
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00632112 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:

large volume nebulizer

Study placed in the following topic categories:

Asthma

ClinicalTrials.gov processed this record on September 10, 2009