An Affordable Cuff-Less Blood Pressure Estimation Solution* Monika Jain, Niranjan Kumar, Sujay Deb IIIT-Delhi, Department of Electronics and Communication, New Delhi, India Abstract—This paper presents a cuff-less hypertension prescreening device that non-invasively monitors the Blood Pressure (BP) and Heart Rate (HR) continuously. The proposed device simultaneously records two clinically significant and highly correlated biomedical signals, viz., Electrocardiogram (ECG) and Photoplethysmogram (PPG). The device provides a common data acquisition platform that can interface with PC/laptop, Smart phone/tablet and Raspberry-pi etc. The hardware stores and processes the recorded ECG and PPG in order to extract the real-time BP and HR using kernel regression approach. The BP and HR estimation error is measured in terms of normalized mean square error, Error Standard Deviation (ESD) and Mean Absolute Error (MAE), with respect to a clinically proven digital BP monitor (OMRON HBP1300). The computed error falls under the maximum standard allowable error mentioned by Association for the Advancement of Medical Instrumentation; MAE < 5 mmHg and ESD < 8mmHg. The results are validated using two-tailed dependent sample t-test also. The proposed device is a portable low-cost home and clinic bases solution for continuous health monitoring. Keywords— Cuff-less blood pressure monitoring; Biomedical signal acquisition; Wireless health monitoring I. INTRODUCTION A survey conducted by the World Health Organization shows that by the year 2030, 1.56 billion adults will be living with high blood pressure (hypertension), which accounts for about 1/3rd of the total death count [1]. Hypertension, although, does not have any obvious symptoms or signs, but it does result in many pulmonary and cardiac diseases like myocardial infarction, transient ischemic attack, dementia, mild cognitive impairment, strokes, kidney failure (damage to glomeruli) and many more [2]. Clearly, hypertension is responsible for a number of the cardiovascular diseases, which accounts for about 17 million deaths per year. Hypertension pre-screening seems to be of crucial importance in stemming the rapidly increasing number of deaths from such condition. As a result, hypertension screening based on cardiovascular data analysis has become an active area of research in past few decades; researchers have rigorously analyzed signals like Electrocardiogram (ECG), Photoplethysmogram (PPG), impedance cardiogram and phonocardiogram for monitoring the Blood Pressure (BP). One of the major challenges in such studies is developing a low-cost robust mechanism for collection and automated analysis of cardiovascular data; the data collection *Research supported by Indraprastha Institute of Information Technology- Delhi (IIIT-D), Okhla Phase-III, New Delhi, Delhi- 110020. Monika Jain and Niranjan Kumar are Research Assistants at IIIT-D. (email: [email protected] ; [email protected]). Sujay Deb was with Intel labs, Hillsboro, OR. He is now an Assistant Professor at IIIT-D in Department of Electronics and Communication. (email: [email protected]) 978-1-4577-0220-4/16/$31.00 ©2016 IEEE procedure should be easy, non-invasive and safe enough to gain the confidence of the masses. Further in the collection and analysis phase, the role of a trained medical practitioner should be as small as possible; partially solving the problem of paucity of qualified medical experts in impoverished regions of the world. This study introduces a compact, portable and low-cost health monitoring platform that can collect, process and communicate non-invasive data (ECG and PPG) related to the cardiovascular system and extract BP and HR based on them. In this paper, the platform is shown to work with PC/laptop, smart phone/tablet and Raspberry-pi (R-pi). The device is easy to use and does not need an assistance of a trained medical practitioner during the home based pre- and post-hospitalization care. The high accuracy of BP and HR estimation makes this solution suitable for clinical use as well. Apart from this, the platform is also capable of communicating the data using existing communication infrastructure to cloud-based medical databases for further analysis and reporting. This feature can be used to develop the databases and patients’ follow-ups, which can be accessed by the health centers, hospitals and researchers for further analysis. II. RELATED WORK Many researchers are working towards developing a reliable, affordable, accurate and easy to use BP monitor. Mafi et al. [3] developed a cuff-based hardware that records the oscillometric wave and proposed a pulse morphology based approach for estimating BP. Samria et al. [4] designed a finger PPG sensor using an infra-red LED and Ahmed et al. [5] developed a prototype that records PPG from the user’s head region (temple). In both the cases, features extracted from the recorded PPG are used to estimate the BP. However, estimation of both systolic and diastolic BP based on only PPG may not be a reliable option since PPG has a higher correlation with diastolic as compared to systolic BP [6]. A complementary information must be added in order to support a reliable systolic BP estimation. To overcome this, ECG is generally used due to its high clinical importance. Anisimov et al. [7] introduced a hardware that records user’s ECG (from arm or chest) and PPG (from finger-tip or earlobe). Pulse wave velocity extracted from the recorded ECG-PPG is used for estimating BP. Puke et al. [8] proposed a wearable prototype that records the ECG and PPG from user’s chest (sternum). Pulse wave transit time extracted from ECG-PPG is used to estimate BP. Ahmad et al. [9] developed a cuff-based InBeam prototype in which ECG-assisted oscillometric and Pulse Transit Time (PTT) analysis are seamlessly integrated into the oscillometric BP measurement paradigm. Franco et al. [10] introduced a wearable BP monitoring system that records ECG (from the chest) and PPG (from the forehead). BP is estimated based on pulse 5294 Figure 1. Proposed health monitoring system arrival time which is computed within the ECG sensor node by the means of wireless body sensor network. Most of these devices are cuff based, bulky and requires the patient to keep the hand at the heart level. Hence, these cannot be used for continuous monitoring. Apart from this, some significant advancement can be seen in the field of smartphone-based health monitoring. Visvanathan et al. [11] collected PPG using the built-in camera of the mobile phone. BP is estimated using a large number of PPG based features. Junior et al. [12] proposed smartphone based calculation of PTT using its inbuilt camera and standard microphone. BP estimation is performed using PTT. Lin et al. [13] introduced a mobile phone based body sensor network for continuous BP monitoring. This system consist of three parts: Wrist band (for PPG), HR belt (for ECG) and Smart Phone; PTT extracted from simultaneously recorded ECG-PPG is used in BP estimation. Most of these existing BP monitoring devices either used insufficient signals or utilized very less features from these signal. Also, the methods are not entirely developed, suitably integrated or tested. In this work, we propose a cuff-less health monitoring system that continuously monitors BP and HR based on a large number of parameters extracted from the ECG and PPG. All the components are designed from the first principle and optimized at each step to achieve affordability and accuracy. The estimated cost of the developed system is around 50$. It is also validated against clinically approved BP monitors. III. PROPOSED HEALTH MONITORING SYSTEM We propose a low-cost health monitoring system that can continuously record and communicate the electrical functioning of heart (ECG) and condition of arteries (PPG) concurrently in a non-invasive manner, and analyze them to extract the real-time BP and HR. The system can be seen in Fig. 1 which is subdivided into four parts, viz. (A) Transducer Unit, (B) Preprocessing Unit, (C) Interfacing Unit and (D) Post-Processing. Each unit is subsequently explained as follows: the subject, using pain-free velcro bands. It also has an optical reflective type PPG sensor, designed using LED (5mm, 562-575nm wavelength) and a phototransistor (L14G2 NPN). PPG sensor is placed on the right-hand index finger. PPG sensor and ECG electrodes are shown in Fig. 2. Figure 2. PPG sensor (left) and ECG electrodes (right) B. Preprocessing Unit The ECG and PPG sensor outputs from the transducer unit are noise-prone and weak, and hence, cannot be fed directly to an Analog to Digital Converter (ADC). To precondition the sensor output, filtering and amplification circuits are designed (shown in Fig. 3) using high input impedance operational amplifier MCP6004. Motion artifacts and fluctuating DC baseline are removed using real-time adaptive DC filtering. After preconditioning, each signal is digitized using an ADC. The ADC is selected according to the capabilities of the computing platform. In this study, we have tested two such solutions, one targeting high-speed computing platforms like PC/laptop and another one targeting energy efficient, and highly portable platforms like Android mobile/tablet and R-pi etc. The detail of the ADCs used is given as follows: Atmel AVR XMEGA 128A1 (ATxmega128 A1): The ECG and PPG signals which are to be acquired on PC/laptop or similar high-compute platforms are digitized using the A. Transducer Unit The transducer unit consists of 3-lead non-polarizable ECG electrodes, which are placed on the wrists and left leg of 5295 Figure 3. ECG and PPG preprocessing unit inbuilt 12-bit ADC of ATxmega128 A1 board. This highspeed ADC (2 million samples per second) is used to achieve the maximum data rate of digitization/acquisition for multiple cardiac signals simultaneously – around 1000 samples per second with high resolution. Such ADC will enable the concurrent acquisition of more than two signals as well in future. MCP3208: The analog signals can be digitized and stored using MCP3208 (100-kilo samples per second, 12-bit resolution). It is a low power and standalone ADC, which can be easily interfaced with smart phone or R-Pi based computing platforms. Overall this ADC makes the proposed hardware more affordable and compact. C. Interfacing Unit The interfacing unit support multiple protocols to send the data across different platforms, as shown in Fig. 4. To provide wired USB interface with PC, laptop, tablet and smart phones FT232RL (USB to serial UART interface) is used. The data acquisition on PC/laptop is done at the rate of 1000 samples per second with the baud rate 230400 for ECG and PPG simultaneously. using the detected peaks. HR and BP are calculated based on these parameters and are displayed on the GUI continuously. Since the signals were preprocessed during acquisition, no extra filters were incorporated during the post-processing. IV. EXPERIMENTAL SET-UP ECG and PPG of 72 subjects (aged between 20 to 60 years) are acquired and stored on a PC. The ground truth BP and HR is simultaneously recorded using a clinically proven BP monitor-OMRON HBP1300 (Measured BP and HR). A database is created using the 10 parameters extracted from each ECG-PPG set and the BP-HR measured corresponding to it. 10 subjects in this database gave their readings immediately after a physical exercise. Fig. 5 shows the lab set-up during the data collection procedure. In order to perform three-fold cross-validation, the entire database is randomly divided into three equal parts (24 subjects each). The basic framework followed by most of the researchers for BP prediction is almost the same. All used the regression framework, yx To connect to low power computing devices such as Rpi, Serial Peripheral Interface (SPI) protocol is used [14]. The data acquisition on this R-pi is done at the rate of 1000 samples per second through two channels simultaneously for ECG and PPG. where ‘y’ represents the vector of expected BP (systolic or diastolic), ‘A’ is the matrix of parameter vectors – the rows of ‘A’ correspond to different individuals and the columns correspond to the various parameters and ‘x’ is the regression weights (to be estimated). The regression framework is simple to interpret; the regression weights tell us the relative importance of the various parameters in BP prediction. In this study, we will solve (1) using Radial Basis Function kernel regression [17]. To extract the HR, we simply use: HR (bpm) = 6*(number of R peaks in 10 seconds). This enables the device to update the HR in every 10 seconds on the real time GUIs. D. Post-processing A Graphical User Interface (GUI) is designed for each acquisition platform. The received ECG and PPG are dumped into the GUI and plotted in real time on the respective screens. In the back-end, significant peaks like P, Q, R, S, T peaks in ECG and peaks, foots and dicrotic notches in corresponding PPG are detected (using the peak detection algorithm in [15]). Based on prior domain knowledge, 10 parameters (PTT, Pre-ejection period [16], QRS duration, R peak amplitude, PPG pulse width and height, crest and delta time, augmentation and reflection index [11]) are extracted A. Results The BP and HR estimation accuracy of the proposed device (as compared to OMRON) is measured in terms of normalized mean square error, Mean Absolute Error (MAE) and Error Standard Deviation (ESD) as shown in Table I. The computed error falls under the standard allowable error mentioned by Association for the Advancement of Medical Instrumentation (AAMI); MAE < 5 mmHg and ESD < 8 mmHg [18], and is better as compared to many state-of-theart approaches [5, 7]. The proposed device gives a reliable diastolic as well as systolic BP estimation, unlike others. Figure 4. Interfacing of the developed hardware with different platforms Figure 5. PC based data acquisition set-up; Box 1, 2, 3 shows the ECG sensors and PPG sensor is placed on right hand index finger. 4 shows the acquisition on PC and 5 shows the real time GUI that continuously plots the signal and displays estimated BP, PTT and HR alongside) FT232RL is replaced with IEEE standard 802.15.1 Bluetooth module HC-05 while interfacing wirelessly over the mobile phone. The sampling rate and baud rate for android mobile/tablet, during wired transmission mode, is 200 samples per second and 28800 respectively. 5296 Two-tailed dependent samples t-test [19] is also conducted to verify that there is no statistically significant difference between BP-HR estimated using the proposed device and BP-HR measured using OMRON. The test is conducted for each fold. Prior to conducting the t-test, the assumption of normally distributed BP-HR value differences between the proposed device and OMRON is examined. The assumption is considered true as the skew and kurtosis levels are found to be lesser than the maximum acceptable range for conducting the t-test (skew <│2.0│ and kurtosis <│9.0│) [20]. The null hypothesis: “There is no statistically significant difference between the BP-HR estimations made using the developed device and BP-HR measured using OMRON”, is accepted; the calculated t-value is lesser than the critical tvalue and p>0.01. Table II shows the 99% confidence interval obtained using t-test. TABLE I. Fold I II III Avg. Diastolic BP E2* E3* E1 E2 E3 E1 E2 E3 3.68 4.84 4.21 4.24 3.56 4.71 4.14 4.14 4.48 5.95 5.15 5.19 5.94 5.19 6.28 5.80 3.89 3.67 4.44 4.00 4.29 4.06 4.85 4.40 2.61 3.31 2.95 2.96 1.89 2.29 2.04 2.07 2.23 2.84 2.51 2.53 *E1: Normalized Mean Square Error (%); E2: Mean Absolute Error (mmHg); E3:Error Standard Deviation (mmHg) Fold I II III 99% CONFIDENCE INTERVALS OBTAINED USING T-TEST Systolic BP ( -1.88 , 3.26 ) ( -2.97 , 3.84 ) ( -3.32 , 2.58 ) Diastolic BP ( -4.21 , 0.71 ) ( -1.45 , 3.20 ) (-1.41 , 4.15 ) [2] [3] [4] [5] HR E1* TABLE II. [1] V. Perkovic, R. Huxley, Y. Wu, D. Prabhakaran, and S. MacMahon. [6] BP - HR ESTIMATION ERROR WITH RESPECT TO OMRON Systolic BP REFERENCES [7] [8] [9] HR (-1.88 , 0.67) (-1.42 , 1.84) (-1.65 , 1.24) [10] V. CONCLUSION [11] This paper presents a portable health monitoring solution that records and transmits the clinically significant cardiovascular signals (ECG and PPG) to different acquisition platforms. It also supports immediate and automated analysis of the recorded signals on the acquisition device itself, in order to extract the real-time BP and HR. The validation of device is done against a clinically proven BP monitor (OMRON HBP1300); the BP and HR estimation error falls under the maximum standard allowable error mentioned by AAMI. The device is developed using low cost and locally available off the shelf ICs and discrete components wired on a double-layer printed circuit board. It is an affordable, easy and reliable solution for home or clinic based continuous health monitoring. Also, the system is capable of continuously storing the recorded data on cloudbased medical databases for further analysis. In future, we will explore miniaturization of the proposed device and will modify it into a wearable solution. 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