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

Primary Purpose

Fitness Trackers, Hemodynamic Monitoring, Internet of Things

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mobile Tracking Device (one spot)
Mobile Tracking Device + Activity Sensor (longitudinal)
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Fitness Trackers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wuerzburg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

postoperative Spot Measurements

Longitudinal postoperative Measurements

Arm 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).

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

Outcomes

Primary Outcome Measures

Measurement accuracy
Heart rate as compared to ECG
Measurement accuracy
Oxygen saturation as compared to arterial blood gas analysis

Secondary Outcome Measures

Patient compliance with mobile tracking devices
As measured by a survey
Postoperative inertial movement
As measured by an inertial activity sensor (MoveSense®) in "inertial measurement units" (IMU)
Postoperative step count
As measured by tracking devices in steps per day

Full Information

First Posted
May 18, 2022
Last Updated
June 9, 2022
Sponsor
Wuerzburg University Hospital
Collaborators
University of Wuerzburg
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1. Study Identification

Unique Protocol Identification Number
NCT05418881
Brief Title
Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)
Acronym
MONITOR
Official Title
Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
University of Wuerzburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fitness Trackers, Hemodynamic Monitoring, Internet of Things, Postoperative Complications, Wearable Electronic Devices, Anesthesia, Surgery

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
postoperative Spot Measurements
Arm Type
Other
Arm 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).
Arm Title
Longitudinal postoperative Measurements
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Mobile Tracking Device (one spot)
Intervention Description
Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).
Intervention Type
Device
Intervention Name(s)
Mobile Tracking Device + Activity Sensor (longitudinal)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement accuracy
Description
Heart rate as compared to ECG
Time Frame
postoperative until hospital discharge up to 21 days
Title
Measurement accuracy
Description
Oxygen saturation as compared to arterial blood gas analysis
Time Frame
postoperative until hospital discharge up to 21 days
Secondary Outcome Measure Information:
Title
Patient compliance with mobile tracking devices
Description
As measured by a survey
Time Frame
postoperative until hospital discharge up to 21 days
Title
Postoperative inertial movement
Description
As measured by an inertial activity sensor (MoveSense®) in "inertial measurement units" (IMU)
Time Frame
postoperative until hospital discharge up to 21 days
Title
Postoperative step count
Description
As measured by tracking devices in steps per day
Time Frame
postoperative until hospital discharge up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Helmer, Dr.
Phone
+49 (931) 201 30574
Email
helmer_p@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Hottenrott
Phone
+49 (931) 201 30563
Email
hottenrott_s@ukw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Meybohm, Prof. Dr.
Organizational Affiliation
Wuerzburg University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Wuerzburg University Hospital
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Helmer, Dr.
Phone
+4993120130574
Email
helmer_p@ukw.de
First Name & Middle Initial & Last Name & Degree
Sebastian Hottenrott
Phone
+4993120130563
Email
hottenrott_s@ukw.de

12. IPD Sharing Statement

Learn more about this trial

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

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