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

NCT03572751 | Completed

• 1 other identifier: R17027
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sensor; Wearable

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Duration of light sleep

  24 hours

• Duration of rapid eye movement (REM) sleep

  24 hours

• Duration of deep sleep

  24 hours

Study Arms (2)

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

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

Interventions

Bed-, wrist- and ECG-sensor monitoring DIAGNOSTIC_TEST

Bed-, wrist- and ECG-sensor monitoring

Healthy volunteers; Vascular surgical patients

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caucasian

You may qualify if:

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

You may not qualify if:

• Pacemaker
• Denial

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University of Technology: collaborator
• Tampere University: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, FI-33014, Finland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Hemorrhage; Shock, Septic; Unconsciousness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: June 28, 2018
• Study Start: April 9, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)