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

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.

Study Overview

• Status: Completed
• Conditions: Occupational Exposure
• Intervention / Treatment: Other: Qualitative Fit Testing

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • UVAHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: N95 Filtering Facepiece Respirator; Subjects will wear the model of filtering facepiece respirator that they are currently approved to wear	Other: Qualitative Fit Testing; Qualitative fit testing with denatonium benzoate
ACTIVE_COMPARATOR: Elastomeric Half-Mask Respirator with P100 filters; Subjects will wear the model of elastomeric half mask respirator that they are currently approved to wear.	Other: Qualitative Fit Testing; Qualitative fit testing with denatonium benzoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Detection of Testing Agent	Subject reported detection of testing agent	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to detection of testing agent	Time to subject reported detection of testing agent	2 minutes

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Andrew Barros, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2020
• Primary Completion (ACTUAL): November 4, 2020
• Study Completion (ACTUAL): November 4, 2020

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Respirator; Cardiopulmonary resusitation
• Other Study ID Numbers: HSR200209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No