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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Arkansas Children's Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
S&T Medical Technologies Inc
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00632112
First received: February 29, 2008
Last updated: June 3, 2009
Last verified: June 2009
  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: Time Perspective: Prospective
Official Title: A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Resource links provided by NLM:


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 ]

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

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014