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

Not Applicable

• Conditions: Postoperative Complications; Wearable Electronic Devices; Anesthesia; Fitness Trackers; Hemodynamic Monitoring; Surgery; Internet of Things
• Interventions: Device: Mobile Tracking Device (one spot); Device: Mobile Tracking Device + Activity Sensor (longitudinal)

• Registration Number: NCT05418881
• Lead Sponsor: Wuerzburg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-05-18
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postoperative Spot Measurements	Mobile Tracking Device (one spot)	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).
Longitudinal postoperative Measurements	Mobile Tracking Device (one spot)	Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.
Longitudinal postoperative Measurements	Mobile Tracking Device + Activity Sensor (longitudinal)	Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.

Primary Outcome Measures

Name	Time	Method
Measurement accuracy	postoperative until hospital discharge up to 21 days	Oxygen saturation as compared to arterial blood gas analysis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wuerzburg University Hospital; 🇩🇪 Würzburg, Bavaria, Germany