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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Septic Shock; Sleep; Arrhythmia; Consciousness, Loss of
• Intervention / Treatment: Diagnostic test: Bed-, wrist- and ECG-sensor monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, FI-33014
    • Tampere university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Caucasian

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pacemaker
• Denial

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vascular surgical patients; 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; Bed-, wrist- and ECG-sensor monitoring
Healthy volunteers; 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; Bed-, wrist- and ECG-sensor monitoring

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University; Tampere University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sensor; Wearable
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Hemorrhage; Unconsciousness
• Other Study ID Numbers: R17027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No