NCT04591756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

9 days

First QC Date

October 12, 2020

Last Update Submit

November 6, 2020

Conditions

Occupational Exposure

Keywords

RespiratorCardiopulmonary resusitation

Outcome Measures

Primary Outcomes (1)

  • Subject Detection of Testing Agent

    Subject reported detection of testing agent

    2 minutes

Secondary Outcomes (1)

  • Time to detection of testing agent

    2 minutes

Study Arms (2)

N95 Filtering Facepiece Respirator

ACTIVE COMPARATOR

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

Other: Qualitative Fit Testing

Elastomeric Half-Mask Respirator with P100 filters

ACTIVE COMPARATOR

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

Other: Qualitative Fit Testing

Interventions

Qualitative Fit TestingOTHER

Qualitative fit testing with denatonium benzoate

Elastomeric Half-Mask Respirator with P100 filtersN95 Filtering Facepiece Respirator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current use of respirator within last 7 days
  • Completed fit test with respirator within last 2 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVAHealth

Charlottesville, Virginia, 22908, United States

Location

Study Officials

  • Andrew Barros, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Medicine, Pulmonary and Critical Care

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 26, 2020

Primary Completion

November 4, 2020

Study Completion

November 4, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)