An Integrated Wearable Wireless Vital Signs Biosensor for Continuous Inpatient Monitoring

A compact, light-weight and low-power wireless vital signs monitoring system based on Wireless Body Area Network (WBAN) protocol has been developed. The system, VySys, includes two compact wearable wireless biosensor devices for continuous vital signs capturing and transmission, a gateway to relay the message collected from the biosensors to cloud, and finally a client apps to access and display the stored data in the cloud. Both biosensor devices can last for 24 hours and weigh less than 22 g and 44 g, respectively. They consist of proprietary in-house bio-sensing integrated circuit (IC) and commercial off-the-shelf Bluetooth Low Energy (BLE) module. VySys has been deployed in clinical trials with 14 subjects. From the studies, the accuracy and advantage of VySys are evaluated and the five vital signs captured (heart rate (HR), respiration rate (RR), temperature (TMP), oxygen saturation (SpO2) and systolic blood pressure (SBP)) are benchmarked against a commercial medical-grade device. The results show strong statistical correlation ( $ {r} > 0.68$ ). In terms of clinical significance, all its mean difference are within limits of accepted clinical discrepancies. In terms of efficacy by comparing against the best known reported results, (1) VsSys is more precise by 28.2%, 36.2%, 70.0%, 37.6% and 34.4% for HR, RR, TMP, SpO2 and SBP, respectively and (2) has a narrower 95% limit of agreement (LoA) by 24.5%, 23.9%, 50.6%, 37.4% and 34.4% for HR, RR, TMP, SpO2 and SBP, respectively.

[1]  Satoshi Suzuki,et al.  Vital-SCOPE: Design and Evaluation of a Smart Vital Sign Monitor for Simultaneous Measurement of Pulse Rate, Respiratory Rate, and Body Temperature for Patient Monitoring , 2018, J. Sensors.

[2]  Benoit Gosselin,et al.  A Wireless Respiratory Monitoring System Using a Wearable Patch Sensor Network , 2019, IEEE Sensors Journal.

[3]  Michael A Rosenberg,et al.  Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study , 2012, Pacing and clinical electrophysiology : PACE.

[4]  Organización Mundial de la Salud Global Health and Aging , 2011 .

[5]  C. H. Heng,et al.  A 2.3 $\mu$ W ECG-On-Chip for Wireless Wearable Sensors , 2018, IEEE Transactions on Circuits and Systems II: Express Briefs.

[6]  Eileen M. Crimmins,et al.  Lifespan and Healthspan: Past, Present, and Promise. , 2015, The Gerontologist.

[7]  Yong Lian,et al.  An ECG-on-Chip With 535 nW/Channel Integrated Lossless Data Compressor for Wireless Sensors , 2014, IEEE Journal of Solid-State Circuits.

[8]  Michiko Nishiyama,et al.  Smart Textile Using Hetero-Core Optical Fiber for Heartbeat and Respiration Monitoring , 2018, IEEE Sensors Journal.

[9]  Oguz Akbilgic,et al.  Improved detection of congestive heart failure via probabilistic symbolic pattern recognition and heart rate variability metrics , 2017, Int. J. Medical Informatics.

[10]  D. Bai,et al.  Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature , 2018, Psychiatry investigation.

[11]  Irina M. Perreard,et al.  Improving Patient Safety and Clinician Workflow in the General Care Setting With Enhanced Surveillance Monitoring , 2019, IEEE Journal of Biomedical and Health Informatics.

[12]  Reza Malekian,et al.  Body Sensor Network for Mobile Health Monitoring, a Diagnosis and Anticipating System , 2015, IEEE Sensors Journal.

[13]  J M Bland,et al.  Statistical methods for assessing agreement between two methods of clinical measurement , 1986 .

[14]  Andreas Patzak,et al.  Continuous blood pressure measurement using pulse transit time , 2013, Somnologie - Schlafforschung und Schlafmedizin.

[15]  Chun-Huat Heng,et al.  A 3-Lead ECG-on-Chip with QRS Detection and Lossless Compression for Wireless Sensors , 2016, IEEE Transactions on Circuits and Systems II: Express Briefs.

[16]  Y. Luo A 74-μW 11-Mbps Wireless Vital Signs Monitoring SoC for 3-Lead ECG , Respiration Rate , and Body Temperature , 2019 .

[17]  Su-Shin Ang,et al.  Assessment of the feasibility of an ultra-low power, wireless digital patch for the continuous ambulatory monitoring of vital signs , 2015, BMJ Open.

[18]  Cor J Kalkman,et al.  Reliability of wireless monitoring using a wearable patch sensor in high-risk surgical patients at a step-down unit in the Netherlands: a clinical validation study , 2018, BMJ Open.

[19]  Chun-Huat Heng,et al.  Continuous ECG Monitoring Trial for Outpatient – Patient Receptiveness and Signal Accuracy , 2019, 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[20]  Chacko John Deepu,et al.  An ECG-on-chip with joint QRS detection & data compression for wearable sensors , 2016, 2016 IEEE International Symposium on Circuits and Systems (ISCAS).

[21]  Haniye Sadat Sajadi,et al.  Trends in future health financing and coverage: future health spending and universal health coverage in 188 countries, 2016–40 , 2018, The Lancet.

[22]  H. van Goor,et al.  Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study , 2017, JMIR mHealth and uHealth.

[23]  Richard Taylor Interpretation of the Correlation Coefficient: A Basic Review , 1990 .

[24]  Mehul Motani,et al.  A RESTful web networking framework for vital sign monitoring , 2015, 2015 IEEE International Conference on Communications (ICC).

[25]  Keiichi Ochiai,et al.  Arrhythmia Detection from 2-lead ECG using Convolutional Denoising Autoencoders , 2018 .

[26]  S Suave Lobodzinski,et al.  ECG patch monitors for assessment of cardiac rhythm abnormalities. , 2013, Progress in cardiovascular diseases.

[27]  S. Oak,et al.  How to Design Peripheral Oxygen Saturation (SpO 2 ) and Optical Heart Rate Monitoring (OHRM) Systems Using the AFE4403 , 2015 .

[28]  H. van Goor,et al.  A smart all-in-one device to measure vital signs in admitted patients , 2018, PloS one.

[29]  Analytical accuracy of the handheld PICO monitoring device during emergencies , 2019, BMJ Innovations.

[30]  Chun-Huat Heng,et al.  A Low Power 12-bit 1-kS/s SAR ADC for Biomedical Signal Processing , 2019, IEEE Transactions on Circuits and Systems I: Regular Papers.

[31]  Zhe Zhang,et al.  A 2.89 $\mu $ W Dry-Electrode Enabled Clockless Wireless ECG SoC for Wearable Applications , 2016, IEEE Journal of Solid-State Circuits.

[32]  Łukasz Dziuda,et al.  A study of the relationship between the level of anxiety declared by MRI patients in the STAI questionnaire and their respiratory rate acquired by a fibre-optic sensor system , 2019, Scientific Reports.

[33]  D. Altman,et al.  Comparing methods of measurement: why plotting difference against standard method is misleading , 1995, The Lancet.

[34]  Michael M Laks,et al.  New devices for very long-term ECG monitoring. , 2012, Cardiology journal.

[35]  William G. Cochran,et al.  Sampling Techniques, 3rd Edition , 1963 .

[36]  Thomas Watteyne,et al.  Understanding the Limits of LoRaWAN , 2016, IEEE Communications Magazine.

[37]  M.B. Shamsollahi,et al.  ECG Denoising Using Parameters of ECG Dynamical Model as the States of an Extended Kalman Filter , 2007, 2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[38]  Subhas Mukhopadhyay,et al.  Long-range wireless technologies for IoT applications: A review , 2017, 2017 Eleventh International Conference on Sensing Technology (ICST).

[39]  Zhihao Chen,et al.  Textile Fiber Optic Microbend Sensor Used for Heartbeat and Respiration Monitoring , 2015, IEEE Sensors Journal.