Draagbare geïntegreerde technologie voor gezondheidsmonitoring. Prof. dr. ir. Ronald Thoelen Genk, January

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1 Draagbare geïntegreerde technologie voor gezondheidsmonitoring Prof. dr. ir. Ronald Thoelen Genk, January

2 wear IT 4 health A total budget of 4,6 M funded by Interreg EMR - European Regional Development Fund, 3 partner regions and all the project partners January 1 st 2017 December

3 Present situation of a classical hospitalisation Hospitalized patients in a bed No autonomy Multiple manipulations need to be performed by the nurses Manual encoding of data Nurses overloaded

4 Our challenge To bring back the patient at the heart of the healthcare system, and guarantee an optimal follow-up during the hospitalisation

5 Our objective The creation of a wearable multi-sensor monitoring device that is comfortable for the hospitalized patients and compatible with the IT infrastructure of the different hospitals of the Euregio Meuse-Rhine.

6 The consortium Complementarity of skills in textile informatics electronics medical data treatment final users of the device Partner 1 Coordinator: ULg-Interface Entreprises-Université de Liège Partner 1 Scientific Lead Partner: ULg Microsys Partner 2 Centexbel Partner 3 CHU de Liège Partner 4 MUMC+ azm Partner 5 MUMC+ UM Partner 6 KU Leuven M3 BIORES + e-media + AdvISe + ESAT Diepenbeek Partner 7 UHasselt IMO IMOMEC + MHU

7 Euregional added-value The cross-border collaboration is essential to reach the goal of this project We bring in common hospitals and knowledge institutions of the EMR Close collaboration all along the project with several potential developing companies Market and technology watch Prototype tests in the different hospitals of the EMR Create synergies between state-of-the-art skills Strengthen collaboration, communication and exchange of best practice between the hospitals of the EMR High added value: optimal monitoring and care of the patients, beyond the borders

8 Starting point Existing Prototypes (TRL 3 / 4) Deliverable Wearable multi-sensor monitoring device at TRL 6 TRL = Technology Readiness Level TRL6 = To get the monitoring device validated/demonstrated in a relevant environment, in our case in hospital on test-subjects, and on which all certification constraints have been taken into account

9 Hospitalised patient Wearable multi-sensor monitoring device Nurses Doctors Specialists Shared Electronic Medical Record Compatible with the IT infrastructure of the different hospitals of the EMR Improved care

10 Co-creation sessions + Market analysis Continuous Market Analysis Medical council Experts in certification Business and Product Features analysis SYSTEM Research and development of sensors Hardware and packaging Software and data management Final testing in hospital

11 1 device/patient with ID number Hospital Network Local servers: Raw signal processing to estimate vital parameters Electronic Medical Register Optimization of data s Interpretation Multi-sensors Data Compression + encryption Integration of data into the patient emr

12 Co-creation strategy Delphi method for consensus on specification list 3 rounds 1. Open oral inventory Workshop (partners + internal experts), Patient interviews 2. Written (anonymous) prioritizing survey Partners, internal experts, external experts 3. Consent based decision round Partners

13 Vital parameters Usage

14 Feedback Design

15 Technical specs

16 Vital parameters Usage Feedback Technical specs Design + Market Analysis

17 Why fixing the intended use? Progress faster Optimize the development Certification

18 PATIENT 0. Multi-sensors LOCAL SERVER 1. Raw signals 2. Parameters 3. Data interpretation & analysis 4. Alarms EMR Medical Report Raw signals?

19 0. Multi-sensors 1. Raw signal ECG PPG Z T ACCx,y,z RSSI Patient inputs Battery Level 2. Parameter Based on Heart rate, frequency Falling, Risk of Falling, Dizziness Blood pressure Temperature Breathing frequency Cardiac output Saturation O2 ECG Heart rate variability Location of the patient in room and in hospital Activity and posture Consciousness Mobility, Movements Acceleration - steps/gait/position Glucose level Pain DO2 Delivery of Oxygen Pain, Stress, Well Being self monitored by the patient Tachycardia Breathing pattern ECG ACCx,y,z ECG + PPG T ECG/PPG/Z ECG + PPG PPG ECG ECG RSSI ACCx,y,z??? ACCx,y,z ACCx,y,z Invasive!??? Connectors? Patient inputs ECG Z

20 2. Parameter Name Based on Time interval between 2 measurements CHU MHU azm I.U. Dia Card Pneu Card Post Surg HR, HRV, Tachycardia ECG 10s Few sec Few sec Few sec Few sec Few sec SBP/ DBP/ MBP/ BPV ECG + PPG >15min 2-3min 5-10min 5-10min 2-3min Few sec SO2 PPG 5-10min 5-10min 5-10min Few sec Few sec BR ECG/PPG/Z 10s 2-3min 5-10min 5-10min 5-10min Few sec T T 15min >15min >15min >15min >15min >15min ECG ECG Few sec Few sec Few sec Few sec Few sec Patient Location RSSI Activity/posture/Falling ACCx,y,z >15min >15min Breathing pattern Z >15min 5-10min Few sec Self monitoring by the patient Patient inputs BELT or not BELT???? Is a patch sufficient???

21 Data to Transfer Sensor Data to send Sampling Rate Data Frequency Data Rate ECG ECG 200Hz 10s ~ 4kB/10s PPG PPG 100Hz 10s ~ 2kB/10s Z Z 10Hz 10s ~ 200B/10s T averaged T / 15min ~ 2B/15min ACCx,y,z Position + activity / 2min ~ 2B/2min

22 Data interpretation & Analyses Data display (existing software, data format, )?? All parameters should not be displayed in RT Only display if something wrong EWS (Early warning score): Score Prediction alerts?

23 Technical Spec CHU MHU azm Dia Card Pneu Card Post Surg Length of stay 4h 10d 10d 3d 4-6d Mobility Waterproof Alarms Display Only alarm Only alarm Only alarm Only alarm Only alarm Medical Report

24 The Intended Use The wearit4health system is a wireless waterproof wearable system intended for use by healthcare professionals in hospital to monitor patients. It continuously monitors heart rate (HR), blood pressure (cnibp), breathing rate (BR), oxygen saturation (SPO 2 ), temperature (T), electrocardiography (ECG), heart rate variability (HRV), cardiac output (CO), human activity recognition (intensity, posture, falling risk,...) and in-hospital patient localization (LOC). Data are transmitted wirelessly from the wearable device on the patient to a local server for further analysis. The early warning score is estimated every 10s as well as a EWS prediction up to several days. The wearit4health system can also notify healthcare professionals when physiological data fall outside specified ranges of selected parameters via smartphone connected to the hospital network. The device is intended for use on general nursing ward patients. It is designed to allow mobility for adult patients (>=18 years old) to provide physiological information. The data from this system are intended for use by healthcare professionals as an aid to monitor patients. The device is neither intended for use on critical care patients nor for diagnosis.

25 Identification and validation of different individual sensors 10 5 LED IR mm mm

26 In-hospital reference devices MacLab hemodynamic recording system Philips MX800 monitor SensorMedics Vmax Encore

27 Development and integration of the wearable monitoring device or how to make it a product? Shared Medical Record

28 Tests in hospitals (duration : 9 months) in 2019 Tests of prototype developed will take place in various locations identified so far : CHU de Liège Cardiology Care Unit CHU de Liège Dialysis unit Maastricht UMC General surgical ward ZOL Genk Cardiology Unit

29 Our objective The creation of a wearable multi-sensor monitoring device that is comfortable for the hospitalized patients and compatible with the IT infrastructure of the different hospitals of the Euregio Meuse-Rhine.

30 With the support of the European Regional Development Fund. The European Union investing in your future.

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32 Really pleased to collaborate with all of you!

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