Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.
研究概览
简要总结
In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 patients immediately after in-ward surgery and over 7 days.
详细描述
The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: Electrocardiogram (ECG) trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.
The aim of this study is to determine the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artefactual data and stability of data transmission. The study population includes 60 patients undergoing visceral or digestive surgery. Once in the post-operative monitoring room, the MultiSense® strip will be attached on patient's thorax. The monitoring will last 7 days through post-operative monitoring room (continuous comparison with reference monitor), general ward (comparison with spot-check monitoring) and patient's home.
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
- •Man or woman over 18 years old
- •Patient programmed for an elective in-ward surgery
- •Patient located in Strasbourg area
- •Patient with Wi-Fi and/or Cellular connectivity at home
- •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 a skin disease that would not allow the use of an adhesive
- •Patient with an implantable device such as a pacemaker
- •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
结局指标
主要结局
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of stability of data transmission.
时间窗: from patch placement to hospital discharge, assessed up to 1 week
Data transmission stability is defined as a data transmission rate equal to or greater than 80 percent.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy.
时间窗: from patch placement to hospital discharge, assessed up to 1 week
Accuracy is defined as an average measurement variation less than 3.5 percent or 5 percent of the mean value, depending on the variable with respect to the reference standard.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of generation of artefactual data.
时间窗: from patch placement to hospital discharge, assessed up to 1 week
The generation of artefact data is defined as a percentage of outlier data less than 10 percent.
Determination of the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of connectivity.
时间窗: from patch placement to hospital discharge, assessed up to 1 week
Connectivity is defined as a time-wise ratio of missing versus total signal less than 20 percent.
次要结局
- Usability of a data acquisition patch by health care providers (HCPs) in different hospital settings assessed via questionnaires.(At hospital discharge, up to 7 days after the patch placement)
- User experience of surgical patients with the continuous use of a data acquisition patch during remote postoperative monitoring assessed via patient's final questionnaires.(From patch placement to its removal (7 days))
- Assess patients' tolerability to prolonged use of an adhesive patch during remote postoperative monitoring.(From patch placement to its removal (7 days))