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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00632112
• Other study ID #: 98551
• Status: Unknown status
• Phase: N/A
• First received: February 29, 2008
• Last updated: June 3, 2009
• Start date: March 2008

Study information

• Verified date: June 2009
• Source: Arkansas Children's Hospital Research Institute
• Contact: Ariel Berlinski, M.D.
• Phone: 501-364-1006
• Email: berlinskiariel[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	S&T Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nebulizer solution output		every 2 hours for first 6 hours