Evaluation of the Relability and Validity of Device for the Screening of Early Pressure Ulcer in Hospitalization High-risk Patient, the Sub Epidermal Moisture During a Monocebtric Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Evaluation of the validity of the SEM Scanner on at risk population
研究概览
简要总结
The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician
详细描述
The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician.
The study "RELIASEM" will study hospitalized patients with high risk of Pressure Injurieswith the next conditions:
For each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. This set of measure will be realized 2 timesby 4 different evaluator. To will have been trained in the use of the SEM Scanner where as the other will be novice.
The main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the SEM Scanner
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18
- •Taken the full-hospital care in physical and rehabilitation Medicine
- •Patient affiliated with a social security scheme
- •In the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator
- •In the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree),
排除标准
- •Patient who objected his opposition during the exam
- •Patient who have one or more presure ulcer on at list one of the measuring area
- •Patient who has had a lower limb amputation
- •Pregnant, post natal period or breastfeeding women,
- •Person deprived of liberty by judicial or administrative decision
结局指标
主要结局
Evaluation of the validity of the SEM Scanner on at risk population
时间窗: During the evaluation 1 day assessed
The Norton scale will be used by the study :Norton ≥ 18 low or without risk, 14\< Norton \<18 medium risk, 12≤ Norton ≤14 high risk, Norton \< 12 very high risk
Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)
时间窗: immediately after the intervention
We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced)
次要结局
- valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated(immediately after the intervention)
- Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)(immediately after the intervention)