Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance
研究概览
简要总结
The current outbreak of Covid-19 requires the wearing of FFP2 respiratory protective devices by healthcare personnel to limit their contamination.
However, there is currently a shortage of masks in France due to insufficient national stocks while the disease is spreading.
There is an urgent need to save FFP2 masks to enable healthcare personnel to continue to provide care in complete safety. Contamination of staff due to insufficient masks would have consequences by limiting access to care for infected patients and putting caregivers at potential risk of death. Caregiver protection is also intended to contain the risk of nosocomial epidemics. We propose the use of ARFC masks by Covid-19+ units. These ARFC masks provide optimal security against the risk of aerosolization of contaminated biological liquids. They are masks modified to be usable by civilians, resulting from the technology of combat masks, specially designed for use in NRBC (Nuclear, Radiological, Biological and Chemical) atmosphere.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at the hospital of Saint Etienne.
- •Subjects affiliated to or entitled to a social security scheme
- •Subject who received informed information about the study and agreed to participate in the study
排除标准
- •Allergy to ARCF mask material: polyurethane
- •Impossibility of supporting a tight mask on the face
- •Potential contraindication to wearing a mask, such as the existence of claustrophobia
- •Beard and moustache wearer
- •Suspicion of COVID-19 infection
- •Refusal to participate.
结局指标
主要结局
Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance
时间窗: Hour: 48
Tolerance will be assessed by the nursing staff by means of a visual analogue scale from 0: no tolerance to 10: perfect tolerance. It will be evaluated 48 hours after the inclusion.
Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.
时间窗: Hour: 48
Compatibility will be assessed by the number of catheter insertion and blood sampling failures in relation to the total number of catheter insertions and blood sampling indicated at 48 hours after the inclusion.
次要结局
- Assess the acceptability of the wearing of an ARFC mask by nursing staff(Hours: 0, 48)
- To assess the minor complications of wearing the ARFC mask .(Hour: 48)