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临床试验/NCT03572751
NCT03572751已完成不适用

Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Accuracy and precision of heart rate (1/s) measurement by a bed sensor

研究概览

简要总结

Novel technology enables it to monitor noninvasively the vital signs of a patient. Such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. In this study, novel bed- and wearable sensors are studied for this purpose.

详细描述

Unobtrusive bed monitoring devices have gained popularity in the area of voluntary sleep quality monitoring for wellness purposes. Most of these devices rely on the measurement of ballistocardiographic forces caused by the acceleration of blood when the heart pumps it to aorta, forces caused by respiration movements and other movements of the person being monitored. A thin film-type force sensor placed under the bed mattress, between the matrices or under the bed sheet is often used for measuring these forces. While proven to provide adequate reliability and accuracy for wellness monitoring of healthy people, unobtrusive bed monitoring solutions have not yet been widely deployed in hospital patient monitoring even though there would be much use for such technology e.g. in regular hospital wards where currently the amount of patient monitoring is very limited.

If proven operational in this application, bed monitoring technology would provide tremendous benefits in both clinical and home monitoring scenarios. Wrist worn pulse plethysmography (PPG) devices have increased their popularity as heart rate monitors, referred as optical heart rate monitors (OHR) for sports and wellness in recent years and their ability to measure average heart rate during movement and beat-to-beat heart rate while at rest accurately with healthy people has been shown.

The objective of the study is to collect ECG and movement data measured with a wearable ECG monitor and simultaneously record data with unobtrusive bed sensor and wrist worn PPG device. Data recorded with the bed and wrist sensors and vital parameters calculated from that or provided by the monitoring devices directly will be compared with the reference.

The purpose of the study is to gain knowledge about the feasibility of unobtrusive bed and wrist monitoring devices for patient monitoring. The collected data will directly provide information on the accuracy of the current algorithms of the monitors. Besides this evaluation, the collected data will be used in developing new algorithms for detection of cardiac problems.

The study includes collection of data from vascular patients referred to surgical operation in Tampere University Hospital. Data collection takes place at vascular surgical ward where one dedicated research bed is equipped with bed monitoring devices. Another group of subjects is formed by healthy volunteers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery
  • Volunteering

排除标准

  • Pacemaker

结局指标

主要结局

Accuracy and precision of heart rate (1/s) measurement by a bed sensor

时间窗: 24 hours

Comparison of bed sensor derived heart rate with ECG reference to determine accuracy and precision of heart rate measurement by a bed sensor

Accuracy and precision of heart rate variability (ms) measurement by a bed sensor

时间窗: 24 hours

Comparison of bed sensor derived heart rate variability with ECG reference

Accuracy and precision of respiratory rate (1/min) measurement by a bed sensor

时间窗: 24 hours

Comparison of bed sensor derived respiratory rate measurement with accelerometer derived reference

Accuracy and precision of body movement detection

时间窗: 24 hours

Comparison of bed sensor derived body movement with accelerometer derived reference

次要结局

  • Duration of light sleep(24 hours)
  • Duration of rapid eye movement (REM) sleep(24 hours)
  • Duration of deep sleep(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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