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

NCT ID: NCT05418881

Last Updated: 2022-06-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-01

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

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).

Group Type OTHER

Mobile Tracking Device (one spot)

Intervention Type DEVICE

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.

Group Type OTHER

Mobile Tracking Device (one spot)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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®).

Intervention Type DEVICE

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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Philipp Helmer, Dr.

Role: CONTACT

+49 (931) 201 30574

Sebastian Hottenrott

Role: CONTACT

+49 (931) 201 30563

Facility Contacts

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Philipp Helmer, Dr.

Role: primary

+4993120130574

Sebastian Hottenrott

Role: backup

+4993120130563

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.

Reference Type DERIVED
PMID: 36583938 (View on PubMed)

Other Identifiers

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MONITOR 2022

Identifier Type: -

Identifier Source: org_study_id

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