Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)

Surgery Clinical Trial

— MONITOR  

Official title:

Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418881
• Other study ID #: MONITOR 2022
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: June 2022
• Source: Wuerzburg University Hospital
• Contact: Philipp Helmer, Dr.
• Phone: +49 (931) 201 30574
• Email: helmer_p[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with elective surgery (= 18 years).

• Written informed consent to participate in the study

• Planned invasive arterial blood pressure measurement

Exclusion Criteria:

• Postoperative invasive ventilation

• American Society of Anaesthesiologists (ASA) Class V

• Outpatient surgical procedure

• Previous participation in this study

• Patients unable to give consent or patients who do not have adequate German language skills

• Suspected lack of compliance

• Skin lesions of the forearms or inability to wear a tracking device

• Known allergy to latex/silicone/nickel

Related Conditions & MeSH terms

• Anesthesia
• Fitness Trackers
• Hemodynamic Monitoring
• Postoperative Complications
• Surgery
• Wearable Electronic Devices

Intervention

Device:
• Mobile Tracking Device (one spot)
Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).
• Mobile Tracking Device + Activity Sensor (longitudinal)
Patients will be fitted with 1 of 3 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, Withings ScanWatch®). The type of tracking device will be randomized. Additionally an Activity Tracker and one-channel ECG (Movesense®) will be worn by the patients.

Locations

Country	Name	City	State
Germany	Wuerzburg University Hospital	Würzburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement accuracy	Heart rate as compared to ECG	postoperative until hospital discharge up to 21 days
Primary	Measurement accuracy	Oxygen saturation as compared to arterial blood gas analysis	postoperative until hospital discharge up to 21 days
Secondary	Patient compliance with mobile tracking devices	As measured by a survey	postoperative until hospital discharge up to 21 days
Secondary	Postoperative inertial movement	As measured by an inertial activity sensor (MoveSense®) in "inertial measurement units" (IMU)	postoperative until hospital discharge up to 21 days
Secondary	Postoperative step count	As measured by tracking devices in steps per day	postoperative until hospital discharge up to 21 days