Molecular and Quantum Acoustics vol. 26, (2005) 235 ACCURACY COMPARISON OF OSCILLOMETRIC AND ELECTRONIC PALPATION BLOOD PRESSURE MEASURING METHODS USING INTRA-ARTERIAL METHOD AS A REFERENCE Hannu SORVOJA, Risto MYLLYLÄ, Päivi KÄRJÄ-KOSKENKARI*, Juha KOSKENKARI**, Mauno LILJA*, Y. Antero KESÄNIEMI* University of Oulu, Department of Electrical and Information Engineering, Optoelectronics and Measurement Techniques Laboratory and Infotech Oulu, PO Box 4500, FIN-90014 University of Oulu, FINLAND *University of Oulu, Dept. of Internal Medicine and Biocenter Oulu, 90220 Oulu, FINLAND **Dept. of Anesthesiology, University Hospital of Oulu, 90220 Oulu, FINLAND [email protected] This paper evaluates blood pressure measurements by the electronic palpation method (EP) and compares their accuracy to that of the oscillometric method (OSC) using average intra-arterial (IA) blood pressure as a reference. All of these three measurements were made simultaneously for each patient. The EP method, based on noninvasively detecting the amplitude of pressure pulsations in the radial artery, differs from the ordinary palpation method by allowing also diastolic pressure to be determined from the pulse delay produced by cuff pressure. In one test group, measurements were conducted on healthy volunteers in sitting and supine position during increasing and decreasing cuff pressure. Another group, comprising older, cardiac patients, was measured only in the supine position during cuff inflation. The results showed that the EP method was approximately as accurate as the OSC method with the healthy subjects and slightly more accurate with the cardiac patient group. The advantage of the EP method is that also the wave shape and velocity of arterial pressure pulses is available for further analysis like the assessment of arterial stiffness. Keywords: noninvasive, blood pressure, cuff, pulse transit time, pulse wave velocity 236 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. 1. INTRODUCTION Most noninvasive blood pressure monitors are based either on the auscultation (AUS) or the oscillometric (OSC) method. The former relies on detecting so-called Korotkoff sounds (automated recording or manual auscultation with a stethoscope) using decreasing cuff pressure and is mainly used in the clinical environment. The automated oscillometric method (OSC), in turn, is widely used in homecare monitoring, due to its ease-of-use. Both methods are widely accepted and often referred to in literature. However, measurements performed with devices based on these methods do not show a particularly good degree of accuracy and repeatability, and a number of such devices are not recommended for use, as they fail to meet the AAMI or BHS standards (ANSI/AAMI 1987, 1993, O’Brien 1990, 1993 and 2001). The electronic palpation (EP) method was firstly introduced in 1998 (Nissilä et al (1998), Sorvoja et al (2001, 2003 and 2004) and Vieri-Gashi et al (2000, 2001). It uses a standard occlusion cuff around the upper arm and a wristwatch type of multi-element pressure transducer array to sense pulsations in the radial artery. Measurements can be made both during increasing and decreasing cuff pressure, also referred to as inflating and deflating pressure mode in this presentation. In these measurements, diastolic blood pressure was defined as the point where the pulse amplitude of the blood pressure signal starts to decrease, while systolic blood pressure was defined as the last pulse detected. Diastolic blood pressure can be defined using two fitted lines that cross at the diastolic pressure. In the experiments described in the paper from 1998, a comparison was made between the EP method on one hand and the OSC and AUS method on the other. These experiments consisted of two sets of measurements. The first set used the auscultation method (15 healthy volunteers), while the other one used the IA method as a reference (seven healthy volunteers). In the first set, each method satisfied the criteria laid down in the AAMI standard, and differences between the methods were small. The second set showed that the accuracy of the EP method in systolic blood pressure measurements exceeded that of the AUS and OSC method. Moreover, the EP method was almost as accurate as the AUS method in diastolic blood pressure measurements, while the OSC method performed poorest. In those measurements, the EP method determines diastolic blood pressure on the basis of changes in the amplitude of pressure pulses. Due to reflections from peripheral arteries and arterioles, the pressure amplitude is slightly higher in the radial than in the brachial artery. Moreover, the amplitude discrepancy varies depending on individual vascular properties (vasoconstriction/vasodilation), which complicates the determination of diastolic blood pressure. If peripheral resistance and pulse wave velocity (PWV) are high, the reflected Molecular and Quantum Acoustics vol. 26, (2005) 237 pressure pulse will augment the incident pressure pulse. Also vascular swelling can have an effect on pulsation amplitude, because the hold-down pressure of the transducer rises. However, cuff pressure affects not only amplitude, but also pulse transit time (PTT). As the increasing cuff pressure level approaches the pressure level in the brachial artery, the pulse transit time from the aorta to the radial artery is correspondingly delayed. This effect is illustrated in Fig. 1. When the pressure produced by the cuff is less or same as the diastolic IA blood pressure, the pulse delay is unaffected. However, as the cuff pressure increases beyond this point, the pulse delay increases markedly and reaches its highest value at the systolic pressure level. Thus, the maximum transit time change equals the time needed for the blood pressure pulse to reach the systolic pressure level, i.e., go from the bottom to the top level (Sorvoja 2001, 2003 and 2004). re Pressure su cuff pres g n ti a l f n I ∆t1 ∆t2 ∆t3 ∆t4 ∆t5 Time Fig. 1. Time elapses as inflating cuff pressure exceeds the diastolic arterial pressure. This pulse transit time method for defining the diastolic pressure on the basis of the pulse delay has been reported in papers published by Geddes et al (1983), Šantić and Šaban (1997), Šantić and Lacković (1999) and Kerola et al (1997). Geddes et al discovered the pulse arrival time, PAT, using an occlusive cuff on anesthetised dogs and invasive pressure measurements from the dogs’ radial arteries. The next two papers deal with diastolic blood pressure determination in a finger, while the third paper describes both diastolic and systolic blood pressure measurements in the brachial artery. The main problem in finger measurements is that blood pressure in a finger is not identical to that in the brachial artery, which is the standard measuring point. The fourth study, by Kerola et al, is impaired by the fact that the distance between the two sensors under the cuff was too short. The result is that when the cuff pressure exceeds the diastolic pressure, the blood volume pushing on the upper side of the cuff produces a rocking effect, which may lead to erroneous sensor signals. In the EP method described in this paper, the transducer is positioned on the radial artery at a distance of about 30 cm from the cuff. Consequently, the sensor records only pressure pulsations in the radial artery. This method of determining diastolic blood pressure has been 238 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. previously discussed by Sorvoja et al. In addition, the recorded wave shape of the pressure pulse can be used to improve the accuracy of systolic blood pressure measurements (Sorvoja et al 2001). Since the EP, OSC and AUS method are all indirect means of measuring blood pressure, based on the occlusion of blood vessels by a cuff, their accuracy may be adversely affected by certain factors, such as the width of the cuff. Alexander et al (1977), for instance, have demonstrated that cuff width must be a specific fraction of the subject’s arm circumference. Thus, an inadequate cuff width produces an overestimate of pressure. Also Geddes and Whistler (1978) have closely examined this ratio, and their results indicate that the fraction should be at least 0.4. Moreover, the sensitivity of the cuff as a transducer is nonlinear. Drzewiecki et al (1993-1995) used a mathematical model to describe the mechanics of the occlusive arm cuff and concluded, among other things, that sensitivity is nonlinear at low pressure ranges and that it plateaus when the pressure level exceeds about 130 mmHg. The OSC method is particularly sensitive to this effect, as the cuff also functions as a pulse oscillation sensor. Cristalli and Ursino (1992-1994, 1996) have shown that also the viscous elastic behaviour of soft tissue may produce a significant pressure error. In soft tissue, the pressure applied by the cuff does not extend to the interior of the tissue. The error increases with the distance from the centre of the cuff. Also the viscosity coefficient and the Young modulus of the arterial wall, heart frequency and pulse amplitude have an effect on accuracy. In the OSC method, both diastolic and systolic pressure are determined by their own specific cuff oscillation ratios. They are obtained by measuring cuff oscillation amplitudes at either the diastolic or systolic point divided by the maximum cuff oscillation amplitude. First, cuff pressure is rapidly inflated above the systolic pressure level and then slowly deflated (in about 30 seconds) to a pressure level under the diastolic pressure level. The oscillation of the cuff achieves its maximum near the mean blood pressure. The mean arterial pressure (MAP) can be determined at the point where the pressure oscillation of the cuff just achieves its maximum, or, for example, ~95% of the maximum, on the diastolic side of the cuff oscillation curve (Ursino and Cristalli 1994, 1996). Geddes et al (1981, 1983) determined the systolic and diastolic pressure values at the oscillation amplitude levels of 0.55 and 0.82 of the maximum. Drzewiecki et al (1994) reported the values of 0.593 and 0.717, respectively, using a theoretical model and a constant input pressure amplitude. However, comprising only two spectral components, their model did not consider the possible spectral diversity of the blood pressure signal. Ursino and Cristalli (1994, 1996), in turn, used a real blood pressure pulse wave in their mathematical study and obtained a ratio of 0.52 for systolic and 0.70 for Molecular and Quantum Acoustics vol. 26, (2005) 239 diastolic blood pressure values. However, the ranges of the ratio deviations were quite wide, extending from a minimum of –12% to a maximum of 23%, which introduces considerable errors. Ursino’s model also showed the influence of arterial stiffening: both MAP and systolic pressure error increased due to stiffening, whereas diastolic error seemed to be independent of it. This stiffness can be described by terms like distensibility, compliance and elastic modulus, which are difficult to measure directly. Indirect measures of arterial stiffness include pulse wave velocity (PWV) and characteristic impedance (Asmar et al 1995 and Asmar 1999, Blacher et al 1999, O’Rourke et al 1992, O’Rourke and Mancia 1999, Safar et al 1998). According to Ursino’s model, the diastolic blood pressure error was mostly affected by pulse pressure. The purpose in this study is to assess the accuracy of the EP method and the OSC method in the same measurements using IA blood pressure as a reference, and define the effects of aging and apparent arterial stiffening on the accuracy of the methods (O’Rourke et al 1992, O’Rourke and Mancia 1999, van der Hejden-Spek et al 2000, van Popele et al 2000). We also aim at establishing the best measuring method and the best algorithm for the determination of diastolic blood pressure in the EP method. Moreover, we shall determine characteristic ratios for the inflating pressure mode in the OSC method, as these ratios and the accuracy of measurements in this mode have not been reported on earlier. 2. METHODS Two sets of measurements were carried out at the Oulu University Hospital in 1997 and 1998/99. Both studies were conducted in the intensive care unit and were approved by the Ethical Committee of the hospital. In the first set, the test subjects were mostly young and healthy volunteers. Parts of this research have been discussed in different conference proceedings (Nissilä et al 1998, Sorvoja et al 2001, 2003 and Vieri-Gashi et al 2000, 2001) and in two journals (Sorvoja et al 2003, Sorvoja and Myllylä 2004), but comparison with OSC method measured simultaneously has not been published before. The other set studied elderly patients who had undergone cardiac surgery (either a bypass or a valve operation, or both). They were first measured immediately after a surgical intervention and then remeasured the next morning, when they woke up. Tables 1 and 2 present the principal characteristics of these two groups, including the subjects’ sex, age, height, weight, body mass index (BMI) and average IA blood pressure value with standard deviations. The first table shows the characteristics of the healthy volunteers and the second one those of the cardiac patient group. Only test subjects with an arm circumference of less than or equal to 33 cm were qualified for later analyses in accordance with Geddes’ findings. 240 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. The IA blood pressure of the healthy volunteers was measured using a catheter (Ohmeda), while their cuff pressure and radial artery pressure pulsation (EP) were measured with a self-made blood pressure measurement device and a laptop PC with a data acquisition card from National Instruments (DAQCardTM 700). The measurements were made twice, in the supine and sitting position in both the inflating and deflating cuff pressure mode with a one-minute follow-up recording period between them. The measurement device consisted of a standard 13 cm cuff, a wristwatch-type four-channel pressure transducer array, an amplifier unit and an automatic pressure-controlling unit. Signals were sampled at the 100 Hz frequency. The transducer array was based on electro-thermo-mechanical film (Kirjavainen 1987, Ficher et al 1990) and was specifically designed for detecting pulsations in the radial artery (Sorvoja et al 2005). Also Ruha et al (1996) and Ruha (1998) have reported on the use of this kind of transducer array for biomedical applications. The amplifier unit was used to amplify and band-pass filter cuff pressure signals (1 - 15 Hz, Butterworth filter response, fourth order high pass, second order low pass) and signals produced by the four-element sensor. Tab. 1. - Study subjects (healthy volunteers). Item n Age, ears Height, cm Weight, kg BMI, kg/m2 Arm circumference, cm Blood pressure measurements, n IA systolic BP, mmHg IA mean BP, mmHg IA diastolic BP, mmHg Heart rate, bpm Men 12 26.2 ± 3.7 180.8 ± 5.6 79.4 ± 10.1 24.2 ± 2.4 31.6 ± 2.6 98 129.1± 11.2 87.3 ± 6.5 67.4 ± 5.0 66.2 ± 11.3 Women 4 30.8 ± 3.0 170.0 ± 2.4 63.5 ± 6.0 22.0 ± 1.9 28.3 ± 2.4 23 122.3 ± 10.1 83.5 ± 5.7 63.7 ± 5.3 69.8 ± 8.1 In the cardiac patient group, the measurements were based on signals produced by the DATEXTM patient monitoring system and another, self-made, blood pressure measurement device. In addition to the device described above, this one also comprised a microprocessor unit for determining blood pressure. In addition, its signal band was also slightly different: four-element transducer signals were amplified and filtered using a first-order band-pass filter (1.7 Hz - 11 Hz) in a full custom integrated circuit. A connection from the DATEX TM device provided an ECG signal and each patient’s radial and pulmonary intra-arterial blood pressure. An automatic pressure-controlling unit, connected to the laptop computer, started cuff pressure inflation and sent all pressure data wirelessly to the microprocessor unit. The Molecular and Quantum Acoustics vol. 26, (2005) 241 microprocessor unit contained the same blood pressure detection algorithm as the laptop computer and was designed to assess the functionality of the whole system. Tab. 2 - Test subjects (cardiac patients). To provide a single value for each patient, the intraarterial (IA) blood pressure (BP) values given are average values of the measured IA diastolic, mean and systolic BP values . Item Number Age, years Height, cm Weight, kg Body mass index, kg/m2 Arm circumference, cm Bypass operation Valve operation Blood pressure measurements, n IA systolic BP, mmHg IA mean BP, mmHg IA diastolic BP, mmHg Heart rate, pulses/min Men 14 67.8 ± 6.8 168.0 ± 8.1 71.4 ± 11.8 25.4 ± 4.4 32.3 ± 1.0 13 3 40 114.8 ± 21.3 77.8 ± 9.2 59.6 ± 6.1 87.2 ± 13.5 Women 6 65.2 ± 9.5 163.0 ± 6.6 74.1 ± 10.0 28.0 ± 4.6 32.7 ± 0.5 4 2 13 118.3 ± 19.9 79.6 ± 14.8 59.6 ± 14.5 81.5 ± 5.4 In the patient group, blood pressure measurements were made 2 - 5 times depending on motion artifacts caused by post-operational shivering. All patients were in supine position, and inflating cuff pressure was used. A medical doctor calibrated and flushed the catheter (Ohmeda) and positioned it at heart level to eliminate the effects of hydrostatic pressure. Of all measurements, 53 qualified for later analysis using averaged results, i.e., each patient was represented by a single value. Most patients were measured in the afternoon shortly after their operation and again in the morning, when they were fully awake and less under medication. A. BLOOD PRESSURE DETERMINATION IN THE OSCILLOMETRIC METHOD In this method, the cuff pressure signal is first filtered using two-second moving average filtering, i.e., every sample is averaged 99 samples back and 100 samples forward using the formula: p(i) = mean[p (i - 99 : i + 100)], (1) where p(i) is the amplitude of the sample and i the corresponding index. The resulting pressure matrix ignores one hundred samples from the beginning and another hundred from the end, which has to be considered in later calculations. The filtered signal is then subtracted from the original pressure signal yielding a high pass filtered oscillation signal with negligible attenuation and phase distortion. This procedure allows the study of the potential effects of analogue filtering on the oscillation curve. The moving average filtered signal serves as a cuff pressure reference signal. To assess the influence of filtering on characteristic ratios, Fig. 2 242 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. presents both the analogically filtered (HW filtering) and the amplified oscillation signal as well as the signal gained by subtracting the two-second moving average filtered signal (SW filtering) from the original cuff signal. Cuff pressure was first low-pass filtered (0 - 14 Hz, fourth order) and then HW band-pass filtered (1 - 15 Hz for the healthy group, 1.7 - 11 Hz for the cardiac patient group) and, finally, amplified to an appropriate signal level. The lowest SW-filtered signal was gained by subtracting the two-second moving average low-pass filtered cuff oscillation signal from the original cuff pressure signal. The thus obtained signal is a high-pass filtered signal with a very low cut-off high-pass frequency. The signal is then amplified to an appropriate signal level using a software multiplier. Oscillation amplitudes are determined by subtracting the diastolic pressure from the systolic pressure (the lower OSC signal). Alternatively, the following lowest value can be subtracted from the highest value (the upper OSC signal) to get an amplitude matrix with pulsation amplitude levels and the 150 IA blood pressure Cuff pressure 100 50 0 -50 HW filtered oscillation SW filtered oscillation Amplitude determinations Cuff oscillations (a.u.) IA blood and cuff pressures (mmHg) corresponding cuff pressures. -100 0 5 10 Time (s) 15 20 25 Fig. 2. From top to bottom: IA blood pressure, increasing cuff pressure, analogically hardware-filtered (HW filtering) and software-filtered (SW filtering) cuff oscillation signals as a function of time. The oscillation amplitude matrix can be reconstituted by multiplying the amplitude matrix by a multiplication matrix in accordance with the formula: k ( j) = mean[p p (first : last )] p p ( j) , (2) where pp(j) is the IA blood pulse pressure corresponding to the oscillation pulse number j. This method allows the reconstruction of the oscillation amplitude matrix so that it is not Molecular and Quantum Acoustics vol. 26, (2005) 243 affected by variations in the IA pulse pressure; in other words, the pulse pressure amplitude remains constant. The oscillation amplitude matrix must then be filtered to eliminate the effects of motion artifacts. Our experiments showed that three-point moving median filtering is adequate for the purpose. Because the cuff pressure curve is not linear in neither the inflating nor the deflating pressure mode, the oscillation matrix must be normalized. After normalization, the amplitude matrix is multiplied by a constant to attain the maximum value of 100. Also the corresponding pressure matrix is multiplied by a scaling multiplier such that the highest point of the oscillation curve, or 95% of the maximum, corresponds to the average mean IA pressure. Also Geddes et al (1983) used a similar scaling factor. As mentioned earlier, this “highest point” should be on the diastolic side of the oscillation curve (Ursino and Cristalli, 1994). Fig. 3 shows a flowchart of all mathematical operations performed on the data to get the systolic, mean and diastolic blood pressure values. First, cuff pressure is sensed by a DC-coupled transducer. The signal is then amplified and band-pass filtered using both HW and SW filtering. Amplitude matrices are subsequently obtained through specific amplitude determination for both the HW and SW signals. The matrices are filtered using three-point moving median filtering to eliminate casual motion artefacts. Next, by multiplying every single pressure value by a multiplier acquired from the IA blood pressure measurement, the matrices are normalized such that 100 % marks the highest value. In addition, the matrices are filled to match every pressure integer value with a corresponding normalized amplitude value (interpolation). Now, both matrices are multiplied by the previously determined scaling multipliers so that the 95% level corresponds to the mean intra-arterial blood pressure value. Finally, the mean diastolic and systolic blood pressure values are determined separately for both the HW and SW filtered signals using the previously determined characteristic ratios. 244 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. C uff pre ssu re se n sor am plifie r Hardware BP filte r (1-14 Hz ) Movin g ave rage LP filte r O rigin al signal – filte re d signal Pe ak de te ction Pe ak de te ction Am plitu de calcu lation Am plitude calcu lation 3 points m oving m e dian filte ring 3 points m oving m e dian filte ring Am plitude n orm aliz ation Am plitu de n orm aliz ation Pre ssu re inte rpolation Pre ssu re inte rpolation Pre ssu re n orm aliz ation Pre ssu re n orm aliz ation Me an blood pre ssure de te rm ination Diastolic blood pre ssu re de te rm in ation S ystolic blood pre ssu re de te rm in ation Fig. 3. Flowchart diagram depicting the oscillometric method. Fig. 4 presents the normalized oscillation curves before and after multiplication and the average value of diastolic, mean and systolic blood pressure as well as the value of the scaling multiplier. The normalized amplitude matrix is then interpolated so that a single integer pressure value corresponds to the oscillation amplitude value. If straight lines are drawn up from the averaged diastolic and systolic IA pressure values, they cross the normalized interpolated curve at the characteristic diastolic and systolic points (the CR values in Fig. 4). The measured patient was a 66-year-old woman, who was 172 cm tall, weighed 75.2 kg and had an arm circumference of 33 cm. The width of her pressure cuff was 13 cm. First, the average values for the mean intra-arterial systolic and diastolic blood pressure are calculated. Then, the scaling multiplier is obtained by multiplying the cuff pressure matrix by the oscillation amplitude, to attain the 95% amplitude level of at the average mean blood pressure. These characteristic ratios are the levels at which the multiplied matrix obtains the averaged systolic and diastolic blood pressures values. Molecular and Quantum Acoustics vol. 26, (2005) 245 100 Normalized oscillation (%) 95% level 80 Systolic CR=49 20 0 0 20 40 IAsys=93 Diastolic CR=32 IAmean=65 40 Scaling multiplier=0.85 IAdias=51 60 60 80 100 Cuff pressure (mmHg) 120 Fig. 4. Determination of the scaling multiplier and characteristic ratios (CR values) for diastolic, mean and systolic blood pressure from the normalized cuff oscillation curve in the oscillometric method. B. BLOOD PRESSURE DETERMINATION IN THE ELECTRONIC PALPATION METHOD 1) SYSTOLIC BLOOD PRESSURE As shown in Fig. 5, systolic blood pressure can be easily determined at the point where the last (or first with deflating cuff pressure mode) radial artery pulse appears in the wrist transducer. We used an array type of transducer to facilitate the placement of the wrist transducer, as the array element with the strongest pulsation is easy to pick out. The figure presents the IA blood pressure signal, band-pass filtered signal and electronically palpated signal at increasing cuff pressure levels. The filtered IA blood pressure signal has exactly the same bandwidth as the electronically palpated signal. The palpated signal does not begin to decrease after the point at which the cuff pressure exceeds the diastolic blood pressure. In fact, the signal amplitude slightly increases, which is why the point where the amplitude signal begins to decrease cannot be used to determine the diastolic blood pressure. Consequently, diastolic pressure is determined at the point where the pulse delay begins to increase, and systolic blood pressure at the point where the last pulse is detected. The cuff pressure in these time points corresponds to the diastolic and systolic pressure. In this measurement, the intra-arterial diastolic blood pressure alternated between 67 and 73 mmHg and the systolic pressure between 152 and 162 mmHg. 246 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. Increasing cuff pressure (mmHg), electronically palpated pulse (a.u.) 200 Intra-arterial blood pressure (mmHg), filtered blood pressure (mmHg) 150 100 50 0 -50 -100 -150 0 5 10 15 20 Time (s) 25 30 35 Fig. 5. Determination of systolic and diastolic blood pressure in the electronic palpation method. 2) DIASTOLIC BLOOD PRESSURE Diastolic blood pressure determination is based on pulse transit time. When pressure in the cuff exceeds the diastolic pressure level, pulses on the distal side of the cuff are delayed. To accurately measure the point where this delay begins requires an accurate timing base. The best timing reference is afforded by the radial artery of the other hand, and, if appropriate data processing is performed, the time difference can be easily determined. Figure 6 presents a flowchart with typical wave shapes for calculating and determining the time delay between the pressure pulses from both hands. Firstly, the IA blood pressure and EP signals are filtered, and the transducer element with the strongest amplitude in the EP transducer array is chosen. After that, the signals are interpolated by a factor of ten to obtain a better timing reference. Both signals are then derivated and the time difference is determined for each pulse on the basis of correlation calculations. The gained matrices are then filtered using three-point moving median and average filtering. Next, the matrices are interpolated so that every cuff pressure integer value has a corresponding pulse delay value. Specific “triangle conversion”, described later, is performed at the following stage to find the cut-off point for line fitting, which is used to establish the point, at which the pulse delay begins to increase. This point indicates the diastolic blood pressure value. Molecular and Quantum Acoustics vol. 26, (2005) IABP (cath e te r) S oftware BP filte r (1 14Hz ) 247 EP se nsor array C uff pre ssu re Hardware BP filte r (1 14Hz ) Moving ave rage LP filte r Extra filte ring Extra filte ring dp/dt dp/dt In te rpolatio Inte rpolatio Inte rpolation 1 Tim e diffe re n ce de te rm ination base d on cross-corre lation 0.8 0.6 0.4 0.2 0 -0.2 -0.4 -0.6 -0.8 0 200 400 600 800 1000 1200 1400 1600 3 poin ts m ovin g m e dian filte ring 3 poin ts m ovin g ave rage filte rin g In te rpolation Triangle con ve rsion Lin e fittin g C rossing point de te ction Diastolic blood pre ssu re de te rm in ation S ystolic blood pre ssu re de te rm in ation from the first/last pu lse Fig. 6. Flowchart diagram for the electronic palpation method. Since the EP blood pressure signal in the radial artery has undergone analogue hardware filtering, the IA pressure signal must be filtered similarly. Further, to eliminate noise that is coupled to the sensor signal from the radial artery, we used additional software band-pass filtering. Owing to the 100 Hz sampling rate used in data acquisition, the data matrices were interpolated for better timing accuracy. According to our experience, an adequate resolution level is achieved at a ten-fold sampling rate. After interpolation, a derivated signal is calculated, and the time difference of these signals is worked out on the basis of correlation calculations, i.e., best correlation corresponds to a situation where the signals overlap one another exactly. Having clearly and accurately determined the time difference, the next step involves locating the point where the pulse delay begins to increase. This turning point can be accurately determined by means of “triangle conversion” after median and moving average filtering and interpolation. In this conversion method, all time values are recalculated to form a triangle, and line fittings are used to establish the accurate turning point. To this end, the time values have to be inverted to obtain decreasing values, and Equation (3) can be applied to attain new values. 248 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. Tnew (i) = Told (i) − ( Told (1) − Told (n) ) * (i − 1) − T n −1 old ( n ) , (3) In this equation, Tnew(i) is the new time value for the index (i), Told(i) the old value and (n) the index value for the last measured time value. In Fig. 7, Fig 7.1 illustrates the increase in pulse delay during the measurement shown in Fig. 5. The pulse time difference matrix is then inverted (Fig 7.2) and filtered using three-point moving median and average filtering (Figs 7.3 and 7.4). In Fig 7.5, the matrix is interpolated and in Fig 7.6, “triangle conversion” is performed to find the diastolic blood pressure. The painted dark areas corresponds each others. Line fitting was used to locate the point at which the line crosses the 100% level. This point correlates to diastolic blood pressure, see arrow in Fig. 7.5. This algorithm provided the value of 67 mmHg for diastolic blood pressure, while the intra-arterial value alternated between 67 and 72 mmHg during the measurement. The last detected pulse corresponds to the systolic pressure and the obtained value, 157 mmHg, is within the systolic pressure range, 152 to 162 mmHg. As seen, the line fitting ranges are clearly defined by the turning point (highest value) and, after that, the crossing point value of the fitted bolded and the 100 % level line can be calculated. This point corresponds to the diastolic blood pressure in the low-pass filtered cuff pressure. Fig. 7. Determination of diastolic blood pressure from the time difference between the filtered and derivated signals of intra-arterial and electronically palpated blood pressure pulses. Molecular and Quantum Acoustics vol. 26, (2005) 249 3. RESULTS A. ACCURACY OF THE OSCILLOMETRIC METHOD IN BLOOD PRESSURE DETERMINATION The oscillation method described earlier was used to determine characteristic ratios separately for the healthy volunteer and the cardiac patient group. For the first group, measurement mode (i.e., inflating and deflating cuff pressure) and position (either supine or sitting) were also considered. Table 3 tabulates the average values for these factors along with standard deviations and scaling multipliers for both groups. As the table shows, the scaling multiplier for the healthy group is about one in every group. The table shows only a slight deviation between measurement mode and position (sitting or supine). The characteristic ratios were found to range from 40% to 48% for diastolic blood pressure and from 49% to 59% for systolic blood pressure in the different modes. The values for diastolic characteristic ratios differ considerably from the mean values reported by Geddes (82%), Drzewiecki (72%) and Ursino (70%). Geddes conducted his measurements on humans, while Drzewiecki and Ursino also used mathematical models and a simple blood pressure signal mode. One explanation to account for the observed discrepancy between their results and the ones reported here is the different oscillation filtering bandwidth used in our experiments. The characteristic ratios for systolic blood pressure obtained in the present study lay within the same range as those reported in the earlier experiments (55%, 59%, 52%, respectively). Another interesting finding is that the standard deviation of the characteristic ratio for diastolic blood pressure was only about 50% of that calculated for systolic pressure. With the cardiac patient group, the scaling multipliers were less than one, 0.86 or 0.87, depending on the filtering mode. The average values of the characteristic ratios are somewhat lower for systolic blood pressure and the standard deviations slightly higher than the corresponding figures for the healthy group. The oscillation amplitude curve was gained by subtracting the two-second moving average filtered cuff oscillation from the unfiltered oscillation curve (SW filtering), which resulted in low degree of distortion. As analogically filtered signals (HW filtering) gave almost identical characteristic ratios, filtering did not have a great effect on accuracy. 250 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. Tab. 3 - Characteristic ratios for diastolic and systolic blood pressure in the healthy and the cardiac patient group. Mode Healthy Inflating Deflating Patients Inflating, Characteristic ratios, % Supine Sitting Supine Sitting Diastolic Systolic 39.6 ± 7.4 45.7 ± 9.4 44.3 ± 6.6 48.1 ± 8.7 48.5 ± 11.6 55.2 ± 16.7 51.2 ± 13.2 58.5 ± 15.3 Supine 45.8 ± 15.6 HW filtering Inflating, Supine 43.9 ± 10.4 SW filtering Scaling multiplier 0.96 ± 0.05 1.01 ± 0.08 1.02 ± 0.05 1.08 ± 0.06 40.6 ± 12.3 0.87 ± 0.07 47.1 ± 13.9 0.86 ± 0.07 These average characteristic ratio values were used to determine both the systolic and diastolic pressure as well as the pressure errors for both groups. The reference values were averaged from the IA pressure waveforms during cuff inflation or deflation, and the mean artery pressure was determined at the point where the cuff oscillation reached 95% of its maximum amplitude curve. The results are presented in Table 4. The pressure error in the healthy group was found to be fairly low, except in the case of sitting test subjects measured during deflation of the cuff, which is the standard procedure used in clinics. This may be due to hydraulic head, i.e., difference in blood level between the reference transducer (catheter) and the cuff. For the patient group, however, the average errors were high, producing overestimates in excess of 10 mmHg, which is outside the standard range. It must be pointed out that the width of the cuff used in these measurements was 40% or more of the subjects’ arm circumference, thus fulfilling the requirements of the standards. In both groups, the standard deviation of errors for systolic blood pressure was too high to fit the standards, regardless of cuff pressure mode and posture. On the other hand, in measurements of diastolic and mean artery pressure, these deviations were less than 8 mmHg, which fulfils the requirements. Molecular and Quantum Acoustics vol. 26, (2005) 251 Tab. 4 - Accuracy of the diastolic, mean and systolic blood pressure measurements in the healthy and the cardiac patient group using the OSC method. The reference value is the average value of the IA diastolic, mean and systolic blood pressure. Mode Healthy Inflating Deflating Patients Inflating, HW filtering Inflating, SW filtering Posture Mean errors Diastolic Mean Systolic (mmHg) (mmHg) (mmHg) 2.8 ± 4.5 4.1 ± 5.0 −0.3 ± 5.40.1 ± 6.9 −1.1 ± 5.1−1.4 ± 3.7 −4.6 ± 6.3−6.5 ± 4.5 4.0 ± 8.4 −1.9 ± 10.1 −3.3 ± 8.5 −9.0 ± 11.0 Supine 12.7 ± 6.113.4 ± 6.8 15.0 ± 11.6 Supine 10.0 ± 5.312.3 ± 7.0 10.2 ± 12.0 Supine Sitting Supine Sitting B. ACCURACY OF THE ELECTRONIC PALPATION METHOD IN BLOOD PRESSURE DETERMINATION Systolic pressure was determined visually from the last palpated pulse, while diastolic blood pressure readings were obtained by the time delay method described above. Reference values were provided by the average IA systolic and diastolic pressure. The corresponding accuracies are presented in Table 5. For the healthy group, the measured accuracies are about the same or lower than in the OSC method during both inflation and deflation of the cuff. On the other hand, the deflating mode yielded better results for diastolic pressure and inflating mode for systolic pressure. For the cardiac patient group, the mean error is -0.6 ± 5.1 mmHg for diastolic and 0.7 ± 6.3 mmHg for systolic pressure, which are considerably better than the accuracies obtained with the OSC method and fulfil both standards. 252 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. Tab. 5. Accuracy of diastolic and systolic blood pressure measurements in the healthy and the cardiac patient group using the EP method. The reference value is the average value of the IA diastolic, mean and systolic blood pressure. Mode Healthy Inflating Supine Sitting Deflating Supine Sitting Patients Inflating Supine Mean errors Diastolic Systolic (mmHg) (mmHg) −5.5 ± 5.2 −11.2 ± 6.1 2.0 ± 6.6 0.1 ± 7.3 −1.7 ± 7.9 −3.2 ± 6.7 −6.3 ± 9.2 −7.1 ± 8.3 −0.6 ± 5.1 0.7 ± 6.3 Other possible determinants for systolic, mean and diastolic blood pressure errors were examined by means of correlation calculations. Correlations between pressure errors and IA pressures are fairly low, the only exception being the correlation between the diastolic pressure errors of the IA and the EP method, which is 0.54. We also noted that the pressure errors were unaffected by the transducer array’s amplitude level. 4. DISCUSSION The mean errors obtained with the OSC method in the cardiac patient group were too large to meet the AAMI and BHS standards, which call for an inaccuracy level of less than 5 mmHg and a standard deviation of less than 8 mmHg. As for the EP method, the errors were considerably lower, fulfilling the requirements of the standards. One possible explanation for the large errors in the OSC method is that the cuff actually serves as a nonlinear sensor. Our analysis employed a scaling multiplier to get the 95% level of the oscillation curve to cross at the mean intra-arterial pressure point. Without a scaling multiplier, the maximum oscillation in Fig. 4 is about 78 mmHg, which overestimates the mean blood pressure by 13 mmHg. The corresponding figures for the EP method in the same measurement are 56/94 mmHg for the diastolic and systolic pressure, while the intra-arterial diastolic and systolic pressures alternate between 47 and 54 mmHg and 89 and 99 mmHg, respectively. This shows that point where the change of delay appears gives a reasonably good estimation of the diastolic blood pressure. In the OSC method, however, the maximum oscillation amplitude is attained at a pressure higher than the mean intra-arterial pressure, producing false readings. In the EP method, when cuff pressure exceeds the venous pressure level, the volume of blood in the hand starts to increase with each heart beat. This induces vascular congestion and a pressure increase in the veins and surrounding tissues in the distal side of the cuff. The Molecular and Quantum Acoustics vol. 26, (2005) 253 velocity of the pressure pulse waves and therefore also the delay change depends exponentially on vascular compliance and the pressure difference between the inner and outer arterial wall. The change of this pressure, also known as transmural pressure, produces a decrease in the pulse wave velocity and a slight increase in the pulse delay, before the diastolic blood pressure level is achieved. This phenomenon is illustrated in Fig. 8. Intraarterial (IA) blood pressure is measured invasively with the catheter tip and radial artery pulsation noninvasively with the electronic palpation transducer. The recorded venous pressure increases slightly until the cuff pressure drops under it. The same phenomenon occurs also with inflating cuff pressure. Owing to venous congestion, the pulse is still slightly delayed at cuff pressures between the diastolic and intra-venous (IV) pressure. The vertical line in centre represents the average diastolic blood pressure value during the measurement and the other lines its minimum and maximum values. According to our experiments (Sorvoja et al 2003), the deflating mode is preferable, due to a smaller increase in vascular pressure. Because this paper used only inflating cuff pressure with the cardiac patient group, additional Cuff pressure, IA & IV pressure (mmHg) comparison and assessment. 200 0 Time delay (ms) -200 5 10 15 50 20 25 Time (s) 30 Electronic palpation signal (a.u.) research focusing on the effects of decreasing pressure is required for a more conclusive 35 40 120 140 0 -50 0 20 40 60 80 100 Cuff pressure (mmHg) Fig 8. Pulsations of the left and right radial arteries and cuff pressure (upper Fig.) as a function of time and pulse delay between the pulses (lower Fig.) as a function of cuff pressure. Vertical lines in the lower Fig. are minimum, average and maximum values of IA diastolic blood pressure. 254 Sorvoja H., Myllylä R., Kärjä-Koskenkari P., Koskenkari J., Lilja M., Kesäniemi Y.A. In the EP method, the ECG signal, being easily detectable in normal subjects, can be used as a timing reference. However, since electrical cardiac activation (ECG) does not constitute mechanical activation (Hong 2000), it is advisable to use pressure pulses instead. The R-spike is followed by a pre-ejection period before the aortic valve opens. This time period depends on the aortic diastolic pressure and the heart constriction rate, and the resulting deviation in the pressure pulse delay renders the determination of blood pressure inaccurate (Meigas et al 2001). The optimal reference point is the radial artery of the other hand, which usually produces almost an identical pulse waveform, thereby greatly facilitating the accurate detection of pulse delays. This method does not provide any information on pulse wave velocity, which could be used for the continuous, pulse-to-pulse monitoring of blood pressure (Chen et al 2000, Meigas et al 2001 and 2003). Nevertheless, pulse wave velocity can be clearly specified in measurements on one hand using, for example, the brachial and radial artery. The shape of pressure pulses, especially optically measured plethysmographic pulses, is quite smooth, and does not provide a very distinct timing point. A better timing reference may be obtained with optical interferometers, such as laser-Doppler systems based on the selfmixing effect (Hast et al 2001, Hast 2003 and Meigas et al. 2001 and 2003). These interferometers measure skin vibrations over an artery with a very high degree of accuracy, restricted theoretically only by the wavelength of the laser divided by two (~300 - 700 nm). Their main advantage is the absence of a loading effect, as the sensor is not in contact with the skin. Also, unlike tonometer type pressure transducers (Drzewiecki et al 1983 and 1996, Kelly et al 1989, Kemmotsu et al 1991, Bansal et al 1994, Drzewiecki and Pilla 1998, Fetics et al 1999), laser-Doppler interferometers do not suffer from sensor movements caused by arterial pulsations. Further, their timing accuracy is very good, because the signal has a much wider bandwidth than a pressure signal. In principle, the time delay method can be used with any transducer that measures pulsations either on the radial artery or a finger. One possibility is to measure noninvasively radial artery pressure pulses in the both hands using either two identical pressure array transducers or interferometers with the same bandwidth. In addition, by measuring the starting time of pressure pulses (opening of the aortic valve) by using, for example, contact microphone on a chest, we will be able to determine the pulse waveform and pulse wave velocity (PWV), which enables noninvasive, pulse-by-pulse monitoring of blood pressure. This needs a daily calibration measurement by using a cuff around an arm. Also pressure pulses measured in the brachial artery under the cuff can be used as a timing base. Finally, detecting the waveform, amplitude and time of pulsations in the radial artery can be utilized in Molecular and Quantum Acoustics vol. 26, (2005) 255 many ways: for example, with other noninvasively measured physiological signals, they can be used to determine arterial compliance or stiffness (O’Rourke et al 1992, Asmar et al 1995, Safar et al 1998, Blacher et al 1999, O’Rourke and Mancia 1999 and Asmar 1999) and central aortic pressure (Kelly et al 1989, Karamonoglu et al 1993, Chen et al 1997 and Fetics et al 1999). 5. CONCLUSIONS Using intra-arterial blood pressure as a reference, this study investigated two measuring methods, the oscillometric (OSC) and the electronic palpation (EP) method. The test subjects comprised a group of healthy volunteers and a group of cardiac patients in intensive care. These patients had undergone either a bypass or a valve operation, or both. The healthy group was measured twice using both inflating and deflating cuff pressure in a sitting and supine position with a one-minute follow-up period between the measurements. The cardiac patient group, on the other hand, was measured only in the supine position with increasing cuff pressure. All measurements were analyzed with the aim of ensuring the best possible accuracy level for both groups. Thus, in the OSC method, case-specific characteristic ratios were used to reach an ideal degree of accuracy. In the EP method, the determination of systolic blood pressure was based on the last palpated pulse, while the determination of diastolic pressure relied on changes in the time delay of the detected signals produced by an occlusion cuff. For better timing accuracy, interpolation was used to increase the sampling rate by a factor of ten. In the oscillometric method, the acquired characteristic ratios for the determination of diastolic blood pressure differed considerably from those reported in the literature, whereas the ratios for systolic blood pressure were within the reported ranges. It was also established that the cuff pressure mode affects accuracy: in the deflating mode, the characteristic ratios were slightly higher than in the inflating mode. Also posture had an effect: both characteristic ratios increased by about 4 - 8 percent when the test subjects were sitting. Age, on the other hand, seemed to have only a minute effect on these ratios, provided that the same cuff pressure mode and position were used in all measurements. In the healthy group, the EP method was found to provide a slightly better degree of accuracy with deflating cuff pressure. With a mean error of about zero and a standard deviation of about 5 – 6 mmHg, also the inflating mode used in the cardiac patient group gave excellent results. 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