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

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ClinicalTrials.gov Identifier: NCT00632112
Recruitment Status : Unknown
Verified June 2009 by Arkansas Children's Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : March 10, 2008
Last Update Posted : June 5, 2009
Sponsor:
Collaborator:
S&T Medical Technologies, Inc.
Information provided by:
Arkansas Children's Hospital Research Institute

Brief Summary:
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 or disease
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
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: A Real Life Evaluation of the Performance of a Large Volume Nebulizer
Study Start Date : March 2008
Estimated Primary Completion Date : July 2009



Primary Outcome Measures :
  1. Nebulizer solution output [ Time Frame: every 2 hours for first 6 hours ]


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ariel Berlinski, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00632112     History of Changes
Other Study ID Numbers: 98551
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009

Keywords provided by Arkansas Children's Hospital Research Institute:
large volume nebulizer