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NCT04591756 Clinical Trial

Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study

Occupational Exposure Clinical Trial

Official title:
Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04591756
Other study ID # HSR200209
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date November 4, 2020

Study information
Verified date November 2020
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing. To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 4, 2020
Est. primary completion date November 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Current use of respirator within last 7 days - Completed fit test with respirator within last 2 years Exclusion Criteria: - Previous adverse reaction to fit testing or testing agent - Development of any health problem that precludes use of a respirator since last occupational health evaluation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Qualitative Fit Testing
Qualitative fit testing with denatonium benzoate

Locations
Country Name City State
United States UVAHealth Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subject Detection of Testing Agent Subject reported detection of testing agent 2 minutes
Secondary Time to detection of testing agent Time to subject reported detection of testing agent 2 minutes
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