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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arrhythmia, Hemorrhage, Septic Shock, Consciousness, Loss of, Sleep

Intervention / Treatment
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* Diagnostic Test: Bed-, wrist- and ECG-sensor monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>50 Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery Volunteering Exclusion Criteria: Pacemaker Denial

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vascular surgical patients<br>Patient subjects are recruited from patients referred for vascular surgical procedure in Tampere University Hospital. Bed-, wrist- and ECG-sensor monitoring | Diagnostic Test: Bed-, wrist- and ECG-sensor monitoring<br>* Bed-, wrist- and ECG-sensor monitoring<br>|
| Healthy volunteers<br>Healthy volunteer subjects will be recruited mainly from the students of Tampere University of Technology. Bed-, wrist- and ECG-sensor monitoring | Diagnostic Test: Bed-, wrist- and ECG-sensor monitoring<br>* Bed-, wrist- and ECG-sensor monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and precision of heart rate (1/s) measurement by a bed sensor | Comparison of bed sensor derived heart rate with ECG reference to determine accuracy and precision of heart rate measurement by a bed sensor | 24 hours | 
| Accuracy and precision of heart rate variability (ms) measurement by a bed sensor | Comparison of bed sensor derived heart rate variability with ECG reference | 24 hours | 
| Accuracy and precision of respiratory rate (1/min) measurement by a bed sensor | Comparison of bed sensor derived respiratory rate measurement with accelerometer derived reference | 24 hours | 
| Accuracy and precision of body movement detection | Comparison of bed sensor derived body movement with accelerometer derived reference | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of light sleep | Measurement of light sleep duration by bed-worn sensor | 24 hours | 
| Duration of rapid eye movement (REM) sleep | Measurement of REM sleep duration by bed-worn sensor | 24 hours | 
| Duration of deep sleep | Measurement of deep sleep duration by bed-worn sensor | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensor, Wearable