Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 10
- 主要终点
- Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
研究概览
简要总结
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.
Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.
详细描述
The proposed study is a prospective, multicenter, interventional and non-comparative research.
This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.
This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.
The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at least 18 years old
- •Patient having a medical prescription for SÉCURIDRAP® SELFIA®
- •Patient in phase or state of disorientation
- •Patient with nocturnal behavior disordre
- •Patient with major cognitive impairment
- •Patient at risk of falling into bed
- •Patient subject to guardianship or curatorship
- •Patient beneficiary or affiliated to a social security scheme
- •Patient who has given their participation agreement aand informed consent
排除标准
- •Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
- •Patient in psychiatry
- •Patient with severe agitation
- •Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
- •Patient with intolerance to the medical device
- •Patient able to extract himself from SÉCURIDRAP® SELFIA®
- •Patient able to unlock the bed rails by himself
- •Patient without social coverage or not benefiting from it through a third party
- •Patient minor, pregnant woman, persons deprived of their liberty
- •Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
结局指标
主要结局
Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
时间窗: [15 days]
quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used
次要结局
- Rate of patients remaining bedridden each night for the duration of the sudy([15 days])
- The learning curve for using SECURIDRAP® SELFIA® by healthcare team([15 days])
- Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient([15 days])
- Rate of occurrence of user errors that could endanger patient safety([15 days])