An observational study in Covid19, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Wake Forest University Health Sciences · Observational
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 21 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical staff who are issued and routinely wear N95 FFR may be screened.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All subjects will be fitted with an OSR M1 N95 mask
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
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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