Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor.
研究概览
简要总结
In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.
详细描述
The MultiSense® solution is a medical device for telemonitoring for in and outpatient use.
It includes 5 physiological data sensors and communicates via Bluetooth with a smartphone. The data is centralized in the web and a web application allows healthcare professionals to scrutinize patient's data.
Among its potential benefits, the MultiSense® solution offers continuous, non-invasive and wireless physiological data recording over 5 days whenever patient monitoring is needed. There is a special focus on the post-operative monitoring, especially during the initial convalescence phase outside the hospital. An automatic notification system can be set up by a healthcare professional to notify abnormal data and potential need for phone call and/or physical home intervention.
The aim of this study is to evaluate the safety, the performance and added value of the MultiSense® solution in real-life situations. The study population includes 20 post-surgical patients having a genuine need for post-hospital monitoring and be likely to have variations in physiological variables monitored, without being in a critical condition. The patients included will be equipped with the MultiSense® solution prior to the hospital discharge. The device will be used for 6 days from the date of actual deployment.
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
- •Adult (male or female over 18 years) in non-critical care settings
- •Patient programmed for an elective surgery
- •Need to monitor at home at least one physiological parameter: heart rate, respiratory rate, SpO2, temperature, physical activity
- •Patient able to use a smartphone
- •Patient with Wi-Fi and/or Cellular connectivity at home
- •Patient with a personal phone which allows to receive text messages
- •Patient able to receive and understand information related to the study and give written informed consent
- •Patient affiliated to the French social security system
排除标准
- •Patient with known skin allergy (adhesive or silicon) or skin disease that would not allow the use of an adhesive
- •Patient with an active implantable device (such as a pacemaker or automatic defibrillator)
- •Patient with an elective imagery planned during the use of MultiSense
- •Pregnant or lactating patient
- •Patient in exclusion period (determined by a previous or a current study)
- •Patient under guardianship or trusteeship
- •Patient under the protection of justice or deprived of liberty
- •Patient in situation of emergency
结局指标
主要结局
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of heart rate accuracy by comparison with a reference monitor.
时间窗: From patch placement to hospital discharge, assessed up to 3 hours
Accuracy is defined as an average measurement variation less than 5 bpm of the mean value, with respect to the reference standard
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data transmission.
时间窗: From patch placement to removal, assessed up to 7 days
Data transmission is defined as more than 90% of data with transmission time from patch to server less than 5 min.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data artefacts.
时间窗: From patch placement to removal, assessed up to 7 days
Percentage of artefacts due to technical issues (non-behavioral events) over the monitoring period below 10% for heart rate, 20% for the respiratory rate or 30% for SpO2.
Determination of the safety and performance of the MultiSense® solution in patient monitoring, in terms of data availability.
时间窗: From patch placement to removal, assessed up to 7 days
Percentage of missing data due to technical issues (non-behavioral events) over the monitoring period below 15%.
次要结局
- Device defects(From patch placement to its removal (up to 7 days))
- Patient's satisfaction and reassurance when monitored by the device(From patch placement to its removal (up to 7 days))
- MultiSense® data quality after moderate level of activity(From patch placement to its removal (up to 7 days))
- Clinical relevance of the notifications provided by MultiSense® solution(From patch placement to its removal (up to 7 days))
- Patient's tolerance to prolonged use of the MultiSense® solution (Safety in use, side effects)(From patch placement to its removal (up to 7 days))
- Remote monitoring facilitation for the healthcare professional through the solution's ease of use and satisfaction gained(From patch placement to its removal (up to 7 days))
- Respiratory rate accuracy in terms of EtCO2(From patch placement to hospital discharge, assessed up to 3 hours)
- Correlation between body temperature and skin temperature(From patch placement to hospital discharge, assessed up to 2 days)
- Respiratory rate accuracy in terms of impedance(From patch placement to hospital discharge, assessed up to 3 hours)
- Patch autonomy(From patch placement to its removal (up to 7 days))
- Estimation of posture and activity level reported by the MultiSense® solution(From patch placement to its removal (up to 7 days))
- End of study hardware recovery rate(From patch removal to material return, assessed up to 1 month)