Verification of Alternative Do-it-yourself Equipment Respirators
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluation of airtightness (Fit test)
研究概览
简要总结
The COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. As alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. The purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type FFP2.
详细描述
The ongoing 2020 COVID-19 pandemic challenges healthcare providers (HCP) worldwide with a rapid consumption and shortage of personal protection equipment (PPE), especially high-level filtration respirator masks. Respirators used by HCPs are mainly single use face filtering pieces with at least level P2 protection for single shift use following European EN 149 standards defining protection level against hazardous particles.
In response to the risk of shortage we propose a novel reusable do-it-yourself (DIY) respirator assembled with already widely available components in hospital stocks: a standard breathing filter plugged in an anaesthesia facial mask held in place with a hook ring strapped to a silicone head harness. As reports of a modified full-face snorkelling (MFS) mask used for non-invasive ventilation in infected patients emerged in Italy, we reckon that it could also be used as PPE with a modified valve and breathing filter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult volunteers working in a first line healthcare service with basic knowledge of donning PPE including respirators
- •5 females and 5 males
排除标准
- •smoking or unhealthy participants with respiratory affections to avoid breathing difficulties during testing
- •any known allergy towards medical silicone or any other material of each component and ingredients used for disinfection of the test area and material between participants
结局指标
主要结局
Evaluation of airtightness (Fit test)
时间窗: Up to 1 week
Non inferiority claim over FFP2
次要结局
- User Comfort(Up to 1 week)
- Breathing easiness(Up to 1 week)
- Ease of use(Up to 1 week)
- Field of view quality(Up to 1 week)