NCT05418881Unknown不适用
Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Measurement accuracy
研究概览
简要总结
The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Patients with elective surgery (≥ 18 years).
- •Written informed consent to participate in the study
- •Planned invasive arterial blood pressure measurement
排除标准
- •Postoperative invasive ventilation
- •American Society of Anaesthesiologists (ASA) Class V
- •Outpatient surgical procedure
- •Previous participation in this study
- •Patients unable to give consent or patients who do not have adequate German language skills
- •Suspected lack of compliance
- •Skin lesions of the forearms or inability to wear a tracking device
- •Known allergy to latex/silicone/nickel
结局指标
主要结局
Measurement accuracy
时间窗: postoperative until hospital discharge up to 21 days
Heart rate as compared to ECG
次要结局
- Postoperative inertial movement(postoperative until hospital discharge up to 21 days)
- Patient compliance with mobile tracking devices(postoperative until hospital discharge up to 21 days)
- Postoperative step count(postoperative until hospital discharge up to 21 days)
研究者
研究点 (2)
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