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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fitness Trackers, Hemodynamic Monitoring, Internet of Things, Postoperative Complications, Wearable Electronic Devices, Anesthesia, Surgery

Intervention / Treatment
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* Device: Mobile Tracking Device (one spot)
* Device: Mobile Tracking Device + Activity Sensor (longitudinal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: postoperative Spot Measurements<br>Measurement of vital signs via 4 different tracking devices in the setting of post-anaesthesia care unit. Simultaneous collection of vital signs measured by the gold standard of clinical monitoring (ecg, blood-gas-analysis, invasive blood pressure, transmissive photoplethysmography). | Device: Mobile Tracking Device (one spot)<br>* Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).<br>|
| Other: Longitudinal postoperative Measurements<br>Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative. | Device: Mobile Tracking Device (one spot)<br>* Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).<br>Device: Mobile Tracking Device + Activity Sensor (longitudinal)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement accuracy | Heart rate as compared to ECG | postoperative until hospital discharge up to 21 days | 
| Measurement accuracy | Oxygen saturation as compared to arterial blood gas analysis | postoperative until hospital discharge up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance with mobile tracking devices | As measured by a survey | postoperative until hospital discharge up to 21 days | 
| Postoperative inertial movement | As measured by an inertial activity sensor (MoveSense®) in inertial measurement units (IMU) | postoperative until hospital discharge up to 21 days | 
| Postoperative step count | As measured by tracking devices in steps per day | postoperative until hospital discharge up to 21 days |