Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733677
Status:
TERMINATED
Last Update Posted:
2023-03-30
First Post:
2021-01-27
Brief Title:
User Experience of the OSR M-1
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NIOSH certification became impossible so decision was made to terminate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 Assess the effectiveness and causation of successfulunsuccessful 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
1 Assess the effectiveness and causation of successfulunsuccessful 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None