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

NCT ID: NCT04591756

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-26

Study Completion Date

2020-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Occupational Exposure

Keywords

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Respirator Cardiopulmonary resusitation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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N95 Filtering Facepiece Respirator

Subjects will wear the model of filtering facepiece respirator that they are currently approved to wear

Group Type ACTIVE_COMPARATOR

Qualitative Fit Testing

Intervention Type OTHER

Qualitative fit testing with denatonium benzoate

Elastomeric Half-Mask Respirator with P100 filters

Subjects will wear the model of elastomeric half mask respirator that they are currently approved to wear.

Group Type ACTIVE_COMPARATOR

Qualitative Fit Testing

Intervention Type OTHER

Qualitative fit testing with denatonium benzoate

Interventions

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Qualitative Fit Testing

Qualitative fit testing with denatonium benzoate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Andrew Barros

Assistant Professor, Department of Medicine, Pulmonary and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Barros, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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UVAHealth

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HSR200209

Identifier Type: -

Identifier Source: org_study_id