Clinical trial NCT04733677: User Experience of the OSR M-1
Official title: User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: COVID
coronavirus
respirator
mask
N99
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical staff who are issued and routinely wear N95 FFR may be screened.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Successful Fits
timeFrame: Day 1
measure: Quality of Fit Score
timeFrame: Day 1
measure: Percentage of Participants that Fit in a Small Size Mask
timeFrame: Day 1
measure: Percentage of Participants that fit in a Medium Size Mask
timeFrame: Day 1
measure: Percentage of Participants that fit in a Large Size Mask
timeFrame: Day 1
measure: User Acceptance Percentage
timeFrame: Day 10
Secondary outcomes:
measure: Percentage of Impression Change
timeFrame: Baseline through Day 10
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Philip J Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: