User Experience of the OSR M-1

Wake Forest University (WFU)

Status: Terminated

Conditions: Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04733677

IRB00070715

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

OSR M-1 N95

Description:

All subjects will be fitted with an OSR M1 N95 mask