NCT01965444已完成不适用
An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.
Bruin Biometrics, LLC1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Descriptive statistic measurements
研究概览
简要总结
The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Subjects are 18 years of age or older.
- •Subject or health care proxy is willing and able to provide informed consent for enrollment.
- •Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
- •Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
- •Subject is not Comfort Measures Only (CMO).
- •Subject is anticipated to be bedridden for ore than 6 hours per day.
- •All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible).
排除标准
- •Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
- •Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
- •Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
- •Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- •Subject is pregnant.
- •Subject is incarcerated.
结局指标
主要结局
Descriptive statistic measurements
时间窗: 5 day study period
The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner.
次要结局
未报告次要终点
研究者
研究点 (1)
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