Anesthesia, Fitness Trackers, Hemodynamic Monitoring, Internet of Things, Postoperative Complications, Surgery, Wearable Electronic Devices
Conditions
Brief 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.
Interventions
DEVICEMobile Tracking Device (one spot)
Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).
DEVICEMobile 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.
Sponsors
University of Wuerzburg
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement accuracy | postoperative until hospital discharge up to 21 days | Heart rate as compared to ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative inertial movement | postoperative until hospital discharge up to 21 days | As measured by an inertial activity sensor (MoveSense®) in inertial measurement units (IMU) |
| Patient compliance with mobile tracking devices | postoperative until hospital discharge up to 21 days | As measured by a survey |
| Postoperative step count | postoperative until hospital discharge up to 21 days | As measured by tracking devices in steps per day |
Countries
Germany
Contacts
Primary ContactPhilipp Helmer, Dr.
Backup ContactSebastian Hottenrott
Outcome results
None listed