User Experience of the OSR M-1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
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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.
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Determine usability, initial and long-term acceptance of the OSR M1 APR relative to standard issue disposable FFRs through user survey and assessment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OSR M-1 N95 All subjects will be fitted with an OSR M1 N95 mask |
Outcome Measures
Primary Outcome Measures
- Percentage of Successful Fits [Day 1]
Percentage of subjects that pass fit-factor testing [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.
- Percentage of Participants that Fit in a Small Size Mask [Day 1]
percentage [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%]
Secondary Outcome Measures
- 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%]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.
Exclusion Criteria:
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Participants unable to pass the fit testing will be excluded from the study.
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Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying medical conditions) will be excluded from the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Philip J Brown, PhD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00070715