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

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04591756
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Days): 9
• Patients Per Site Per Month: 338.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Occupational Exposure	Other: Qualitative Fit Testing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study
• Actual Study Start Date: Oct 26, 2020
• Actual Primary Completion Date: Nov 4, 2020
• Actual Study Completion Date: Nov 4, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Subject Detection of Testing Agent [2 minutes]

   Subject reported detection of testing agent

Secondary Outcome Measures

1. Time to detection of testing agent [2 minutes]

   Time to subject reported detection of testing agent

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UVAHealth	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrew Barros, Assistant Professor, Department of Medicine, Pulmonary and Critical Care, University of Virginia
• ClinicalTrials.gov Identifier: NCT04591756
• Other Study ID Numbers: HSR200209
• First Posted: Oct 19, 2020
• Last Update Posted: Nov 9, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrew Barros, Assistant Professor, Department of Medicine, Pulmonary and Critical Care, University of Virginia: Respirator; Cardiopulmonary resusitation

Study Results

No Results Posted as of Nov 9, 2020