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.
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.
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.
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Philip J Brown, PhD, Principal Investigator
Wake Forest University Health Sciences