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.
Study Type
OBSERVATIONAL
Enrollment
21
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Percentage of Successful Fits
Percentage of subjects that pass fit-factor testing \[0%-100%\]
Time frame: Day 1
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.
Time frame: Day 1
Percentage of Participants that Fit in a Small Size Mask
percentage \[0%-100%\]
Time frame: Day 1
Percentage of Participants that fit in a Medium Size Mask
percentage \[0%-100%\]
Time frame: Day 1
Percentage of Participants that fit in a Large Size Mask
percentage \[0%-100%\]
Time frame: Day 1
User Acceptance Percentage
Percentage of participants that prefer the experimental device over currently used device \[0-100%\]
Time frame: Day 10
Percentage of Impression Change
Changes in impression of the device (pre-trial vs. post-trial) - percentage of positive or negative change \[-100% - +100%\]
Time frame: Baseline through Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.