User Experience of the OSR M-1

Covid19 Clinical Trial

Official title:

User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04733677
• Other study ID #: IRB00070715
• Status: Terminated
• Start date: March 19, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Successful Fits	Percentage of subjects that pass fit-factor testing [0%-100%]	Day 1
Primary	Quality of Fit Score	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.	Day 1
Primary	Percentage of Participants that Fit in a Small Size Mask	percentage [0%-100%]	Day 1
Primary	Percentage of Participants that fit in a Medium Size Mask	percentage [0%-100%]	Day 1
Primary	Percentage of Participants that fit in a Large Size Mask	percentage [0%-100%]	Day 1
Primary	User Acceptance Percentage	Percentage of participants that prefer the experimental device over currently used device [0-100%]	Day 10
Secondary	Percentage of Impression Change	Changes in impression of the device (pre-trial vs. post-trial) - percentage of positive or negative change [-100% - +100%]	Baseline through Day 10