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

NCT ID: NCT03572751

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Vascular surgical patients

Patient subjects are recruited from patients referred for vascular surgical procedure in Tampere University Hospital.

Bed-, wrist- and ECG-sensor monitoring

Bed-, wrist- and ECG-sensor monitoring

Intervention Type: DIAGNOSTIC_TEST

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

Bed-, wrist- and ECG-sensor monitoring

Intervention Type: DIAGNOSTIC_TEST

Bed-, wrist- and ECG-sensor monitoring

Interventions

Bed-, wrist- and ECG-sensor monitoring

Bed-, wrist- and ECG-sensor monitoring

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pacemaker
• Denial

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University of Technology

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

R17027

Identifier Type: -

Identifier Source: org_study_id