Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 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
研究组 & 干预措施
postoperative Spot Measurements
Measurement of vital signs via 4 different tracking devices in the setting of post-anaesthesia care unit. Simultaneous collection of vital signs measured by the gold standard of clinical monitoring (ecg, blood-gas-analysis, invasive blood pressure, transmissive photoplethysmography).
干预措施: Mobile Tracking Device (one spot) (Device)
Longitudinal postoperative Measurements
Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.
干预措施: Mobile Tracking Device (one spot) (Device)
Longitudinal postoperative Measurements
Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.
干预措施: Mobile Tracking Device + Activity Sensor (longitudinal) (Device)
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)