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

Wuerzburg University Hospital

Status: Enrolling

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

Treatments: Device: Mobile Tracking Device + Activity Sensor (longitudinal); Device: Mobile Tracking Device (one spot)

Study type: Interventional

Funder types: Other

Identifiers

NCT05418881

MONITOR 2022

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

postoperative Spot Measurements

Other group

Description:

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).

Treatment:

Device: Mobile Tracking Device (one spot)

Longitudinal postoperative Measurements

Other group

Description:

Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.

Treatment:

Device: Mobile Tracking Device (one spot)

Device: Mobile Tracking Device + Activity Sensor (longitudinal)