Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)
MONITOR
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedJune 14, 2022
June 1, 2022
1.9 years
May 18, 2022
June 9, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Measurement accuracy
Heart rate as compared to ECG
postoperative until hospital discharge up to 21 days
Measurement accuracy
Oxygen saturation as compared to arterial blood gas analysis
postoperative until hospital discharge up to 21 days
Secondary Outcomes (3)
Patient compliance with mobile tracking devices
postoperative until hospital discharge up to 21 days
Postoperative inertial movement
postoperative until hospital discharge up to 21 days
Postoperative step count
postoperative until hospital discharge up to 21 days
Study Arms (2)
postoperative Spot Measurements
OTHERMeasurement 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
OTHERContinuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative.
Interventions
Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).
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
You may qualify if:
- Patients with elective surgery (≥ 18 years).
- Written informed consent to participate in the study
- Planned invasive arterial blood pressure measurement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuerzburg University Hospitallead
- University of Wuerzburgcollaborator
Study Sites (1)
Wuerzburg University Hospital
Würzburg, Bavaria, 97080, Germany
Related Publications (1)
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.
PMID: 36583938DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patrick Meybohm, Prof. Dr.
Wuerzburg University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2022
First Posted
June 14, 2022
Study Start
November 1, 2021
Primary Completion
October 1, 2023
Study Completion
November 1, 2023
Last Updated
June 14, 2022
Record last verified: 2022-06