User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percentage of Successful Fits
研究概览
简要总结
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.
详细描述
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.
- 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.
- Determine usability, initial and long-term acceptance of the OSR M1 APR relative to standard issue disposable FFRs through user survey and assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.
排除标准
- •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.
结局指标
主要结局
Percentage of Successful Fits
时间窗: Day 1
Percentage of subjects that pass fit-factor testing \[0%-100%\]
Percentage of Participants that fit in a Medium Size Mask
时间窗: Day 1
percentage \[0%-100%\]
Percentage of Participants that fit in a Large Size Mask
时间窗: Day 1
percentage \[0%-100%\]
User Acceptance Percentage
时间窗: Day 10
Percentage of participants that prefer the experimental device over currently used device \[0-100%\]
Percentage of Participants that Fit in a Small Size Mask
时间窗: Day 1
percentage \[0%-100%\]
Quality of Fit Score
时间窗: Day 1
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.
次要结局
- Percentage of Impression Change(Baseline through Day 10)