CARESCAPE Monitoring Systems ME Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical evaluation of the performance and usability
研究概览
简要总结
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.
详细描述
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.
In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.
Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).
The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
- •Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
- •Parameter(s) in scope of the study can be collected
排除标准
- •Are known to be pregnant;
- •Are breastfeeding;
- •Are suffering from infection(s) or immunocompromised patients that require isolation.
- •Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
- •PI or designee decision due to subject's health condition
研究组 & 干预措施
data collection
干预措施: Monitoring (Device)
结局指标
主要结局
Clinical evaluation of the performance and usability
时间窗: From admission to discharge, maximum of 24 hours
Primary outcome of this study is to conduct clinical evaluation of the performance and usability of the new software and hardware features introduced to the system by collecting data and surveys.
次要结局
- Collection of data(From admission to discharge, maximum of 24 hours)