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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03572751
Acronym
BedMon
Enrollment
36
Registered
2018-06-28
Start date
2018-04-09
Completion date
2018-12-31
Last updated
2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sensor, Wearable

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTBed-, wrist- and ECG-sensor monitoring

Bed-, wrist- and ECG-sensor monitoring

Sponsors

Tampere University of Technology
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 120 Years

Inclusion criteria

* Age\>50 * Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery * Volunteering

Exclusion criteria

* Pacemaker * Denial

Design outcomes

Primary

MeasureTime frameDescription
Accuracy and precision of heart rate (1/s) measurement by a bed sensor24 hoursComparison 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 sensor24 hoursComparison of bed sensor derived heart rate variability with ECG reference
Accuracy and precision of respiratory rate (1/min) measurement by a bed sensor24 hoursComparison of bed sensor derived respiratory rate measurement with accelerometer derived reference
Accuracy and precision of body movement detection24 hoursComparison of bed sensor derived body movement with accelerometer derived reference

Secondary

MeasureTime frameDescription
Duration of rapid eye movement (REM) sleep24 hoursMeasurement of REM sleep duration by bed-worn sensor
Duration of deep sleep24 hoursMeasurement of deep sleep duration by bed-worn sensor
Duration of light sleep24 hoursMeasurement of light sleep duration by bed-worn sensor

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026