User Experience of the OSR M-1

Terminated

• Conditions: Covid19

• Registration Number: NCT04733677
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this observational study is to verify the user acceptance of the Open Standard Respirator-Model 1 (OSR-M1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. This study will help to guide further design modifications and clarify quantities of employee populations that may benefit from elastomeric respirator use for the deployment of OSR M1 Air Purifying Respirators (APRs) in the Wake Health network.

Detailed Description

The study team hypothesizes that the OSR M-1 APR with National Institute for Occupational Safety and Health classification 99% Airborne Particle Filtration (N99) will have increased fit and seal as well as user comfort and acceptance over disposable National Institute for Occupational Safety and Health classification 95% Airborne Particle Filtration (N95) filter facepiece respirators (FFR). The study team is proposing to assess the acceptance and functional usability of the OSR-M1 in Wake Forest Baptist Health System as a N95 disposable FFR alternative for improved protection and economy.

1. Assess the effectiveness and causation of successful/unsuccessful fit testing of the OSR M1 APR by measuring anthropometry of facial features and performing quantitative fit testing of clinicians.

2. Determine usability, initial and long-term acceptance of the OSR M1 APR relative to standard issue disposable FFRs through user survey and assessment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-02
• Study Start: 2021-03-19
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.

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Exclusion Criteria

• Participants unable to pass the fit testing will be excluded from the study.
• Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying medical conditions) will be excluded from the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Successful Fits	Day 1	Percentage of subjects that pass fit-factor testing \[0%-100%\]
Percentage of Participants that fit in a Medium Size Mask	Day 1	percentage \[0%-100%\]
Percentage of Participants that fit in a Large Size Mask	Day 1	percentage \[0%-100%\]
User Acceptance Percentage	Day 10	Percentage of participants that prefer the experimental device over currently used device \[0-100%\]
Percentage of Participants that Fit in a Small Size Mask	Day 1	percentage \[0%-100%\]
Quality of Fit Score	Day 1	Scores can range from 0 to 10000 with a higher score denoting a better fit. A score of 100 qualifies as a successful OSHA half-mask respirator fit test.

Secondary Outcome Measures

Name	Time	Method
Percentage of Impression Change	Baseline through Day 10	Changes in impression of the device (pre-trial vs. post-trial) - percentage of positive or negative change \[-100% - +100%\]

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States