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

June 9, 2022 updated by: Wuerzburg University Hospital

Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Philipp Helmer, Dr.
  • Phone Number: +49 (931) 201 30574
  • Email: helmer_p@ukw.de

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Wuerzburg University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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).
Device: 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®).
OTHER: 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.
Device: 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®).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement accuracy
Time Frame: postoperative until hospital discharge up to 21 days
Heart rate as compared to ECG
postoperative until hospital discharge up to 21 days
Measurement accuracy
Time Frame: postoperative until hospital discharge up to 21 days
Oxygen saturation as compared to arterial blood gas analysis
postoperative until hospital discharge up to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient compliance with mobile tracking devices
Time Frame: postoperative until hospital discharge up to 21 days
As measured by a survey
postoperative until hospital discharge up to 21 days
Postoperative inertial movement
Time Frame: postoperative until hospital discharge up to 21 days
As measured by an inertial activity sensor (MoveSense®) in "inertial measurement units" (IMU)
postoperative until hospital discharge up to 21 days
Postoperative step count
Time Frame: postoperative until hospital discharge up to 21 days
As measured by tracking devices in steps per day
postoperative until hospital discharge up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

University of Wuerzburg

Investigators

  • Study Director: Patrick Meybohm, Prof. Dr., Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (ACTUAL)

June 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MONITOR 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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