Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)
NCT ID: NCT05418881
Last Updated: 2022-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2021-11-01
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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postoperative Spot Measurements
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).
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®).
Longitudinal postoperative Measurements
Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent to participate in the study
* Planned invasive arterial blood pressure measurement
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Wuerzburg
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Principal Investigators
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Patrick Meybohm, Prof. Dr.
Role: STUDY_DIRECTOR
Wuerzburg University Hospital
Locations
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Wuerzburg University Hospital
Würzburg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Helmer P, Hottenrott S, Rodemers P, Leppich R, Helwich M, Pryss R, Kranke P, Meybohm P, Winkler BE, Sammeth M. Accuracy and Systematic Biases of Heart Rate Measurements by Consumer-Grade Fitness Trackers in Postoperative Patients: Prospective Clinical Trial. J Med Internet Res. 2022 Dec 30;24(12):e42359. doi: 10.2196/42359.
Other Identifiers
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MONITOR 2022
Identifier Type: -
Identifier Source: org_study_id
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