Blood Pressure Measurement Devices Research Articles

Authors' Reply to: Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Authors' Reply to: Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Comment on "Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study".

Sex Differences in Renal T cells in DOCA‐salt Hypertension are not Blood Pressure Dependent.

BackgroundThere is increasing evidence implicating T cells in the development and maintenance of hypertension. Our lab has previously shown that there is a sex difference in renal T cells in deoxycorticosterone acetate salt (DOCA) hypertension, with females having greater T regulatory cells than males. Moreover, Tregs attenuate DOCA‐induced increases in blood pressure (BP) only in female rats. Therefore, the goal of the current study was to test the hypothesis that the sex difference in renal Tregs in DOCA‐salt rats is BP dependent.MethodsAt 10 wks of age, male and female Sprague‐Dawley rats were anesthetized, a right uni‐nephrectomy was performed, and all rats were implanted with telemetry devices for the continuous measurement of BP. After one week of recovery, all rats received a subcutaneous 21‐day slow‐release DOCA pellet (200 mg) with 0.9% saline water to drink. To prevent DOCA‐salt induced increases in BP, a subset of rats (N=9–12/group) were randomized to receive hydrochlorothiazide (HCTZ; 55 mg/kg/day) and reserpine (4.5 mg/kg/day) combined with 0.9% saline in the drinking water for 3 weeks. Rats were individually housed throughout the study. Water intake and body weights were measured every two days and the dose of drugs were altered, as needed, to maintain baseline BP levels. After 3 wks of treatment, the remaining kidney was isolated for flow cytometric analysis of T cells.ResultsAfter 3 wks of DOCA‐treatment, males had a higher BP than females (179 ± 3 mmHg vs. 157 ± 4 mmHg; n=6–7; Psex=0.0001). Treatment with HCTZ and reserpine prevented DOCA‐induced increases in BP in both males (110 ± 5 mmHg) and females (101 ± 5 mmHg; Ptreatment<0.0001; Pinteraction=0.307). With DOCA‐salt induced hypertension, males had more renal CD4+ T cells (expressed as %CD3+ T cells: 63 ± 2 vs 60 ± 1) and Th17 (expressed as %CD3+CD4+ cells: 14 ± 1 vs 11 ±1) than females (Psex=0.04). HCTZ and reserpine decreased both CD4+ cells (expressed as %CD3+ T cells: 61 ± 3.9 vs 60 ±2.9; Ptreatment<0.0001) and Th17 cells (expressed as %CD3+CD4+ cells: 5.15 ±0.93 vs 5.1 ± 1.3; Ptreatment<0.0001) and the decrease was comparable between sexes (CD4+: Pinteraction=0.86; Th17: Pinteraction=0.55). With DOCA alone, females had a higher number of Tregs than males (expressed as %CD3+CD4+ cells: 3.9 ±0.21 vs 2.6 ±0.2; Psex<0.0001). Preventing DOCA‐salt induced increases in BP with HCTZ and reserpine did not significantly change renal Tregs in either sex (Ptreatment=0.11; Pinteraction=0.38).DiscussionOur data suggests that while preventing DOCA‐salt induced increases in BP attenuates the increase in renal pro‐inflammatory T cells, sex differences in renal T cells is not dependent on hypertension.

Validation of the InBody BPBIO250 oscillometric blood pressure monitor for professional office use in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

The aim of this study was to evaluate the accuracy of the InBody BPBIO250 oscillometric upper-arm professional office blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited to fulfil the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). Ninety-seven subjects were recruited and 88 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.9 ± 5.9/0.9 ± 4.9 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.78/4.31 mmHg (systolic/diastolic). The InBody BPBIO250 professional oscillometric device for office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station.

ObjectiveA new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user’s arm prior to bladder inflation. The purpose of this study was to validate the adaptable BP system (ABPS) using the current standards from the Association for the Advancement of Medical Instrumentation (AAMI).MethodsThe AAMI/ISO 81060:2013 standards for clinical validation of non-invasive automated arterial BP measurement devices were followed precisely using the same arm sequential method. For each participant, BP was measured over multiple trials by trained observers alternating a reference sphygmomanometer with the ABPS. All study requirements were met with 85 qualifying participants, each with 3 valid paired determinations.ResultsThe mean difference between ABPS BP and reference BP using all 255 paired determinations was −2.4 ± 7.7 mmHg for systolic and 1.7 ± 5.7 mmHg for diastolic. The standard deviation of the averaged paired determinations per participant was 6.3 mmHg for systolic and 5.2 mmHg for diastolic. Arm circumference measurements had a mean error of −2.1 ± 2.4 cm (R2 = 0.87). A new prediction model for arm circumference was validated using a holdout dataset (R2 = 0.94).ConclusionThe results of the study confirm that the ABPS met all benchmarks established by the AAMI. The device accurately measures BP across a wide range of arm circumferences (24–44 cm) and is suitable for use by individuals to self-monitor BP.

STRIDE BP: an international initiative for accurate blood pressure measurement.

: The diagnosis and management of hypertension is dependent upon accurate blood pressure (BP) measurement. Despite intense efforts over several decades by the international medical community worldwide, the use of inaccurate devices has resulted in the misdiagnosis and poor management of hypertension, which remains a largely unresolved public health problem. STRIDE BP (www.stridebp.org) is an international nonprofit organization the mission of which is to improve the accuracy of BP measurement and the diagnosis of hypertension. STRIDE BP comprises a group of 24 recognized experts in BP monitoring from across the world and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. In the first stage, STRIDE BP has reviewed 419 validations of 260 devices and approved 69% of them, providing recommendations on accurate devices for office, ambulatory and home BP measurement in adults, children and during pregnancy. At the next stage, STRIDE BP intends to develop programs for on-line training and tools for use in clinical practice leading to improved measurement of BP and better diagnosis of hypertension world-wide.

Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement

Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement

Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for professional office BP monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was 1 ± 8/-2 ± 6 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 1 ± 7 mmHg for systolic BP and -2 ± 6 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The OMRON HBP-9031C professional BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.

Comparison of cuff-based and cuffless continuous blood pressure measurements in children and adolescents

ABSTRACT Objective In recent times, new methods of blood pressure measurements have been introduced, including cuffless blood pressure (BP) measurement device using pulse transit time (PTT) for calculation of BP values. However, it is still unknown how values obtained with a new cuffless device compare with standard ambulatory measurements in children. The main aim of the study was to investigate whether BP values measured by a cuffless PTT device are comparable with measurements by a standard upper arm cuff-based BP device. Methods Thirty children were prospectively included. Blood pressure measurements using the cuffless device (Somnotouch-NIBP) and cuff-based standard device (Omron 907) were performed simultaneously on the left and right arm. Results Mean systolic BP of the standard measurements was 123,47 ± 14,91 mmHg and 127,48 ± 15,98 mmHg (p < .001) measured by cuffless method. Mean diastolic BP of the standard ABPM measurements was 66,88 ± 11,86 mmHg and 68,52 ± 12,36 mmHg (p < .001). There were significant positive correlations between standard and cuffless measurements. Conclusion The results show that the created PWV–BP function produces a significant correlation between BP derived from the PWV and the SBP measured by sphygmomanometry. When applying this device in clinical practice, one may keep in mind that the reported mean values over 24 hours, awake and asleep time are not directly interchangeable with cuff-based standard 24-hour BP values. The measured BP values were higher by the new technique. Although differences in SBP between both methods reached values up to 20 mmHg, we think that the development of a cuffless BP monitoring system will provide novel solutions in various medical situations.

Hubungan Kadar High Density Lipoprotein (HDL) Dengan Kejadian Hipertensi

Eventyally this study aims to determine the correlation between HDL levels as a risk factor of hypertension. This research used observational analytic design with cross sectional approach. The independent variable was total cholesterol levels and the dependent variable was hypertension. The research was located in Selabangga Village, Moramo District with the total sample of 57 samples based on the inclusion and exclusion criteria selected by the purposive sampling method. These data were obtained by using a measurement instrument of HDL level (lipids Pro) and blood pressure measurement devices (aneroid sphygmomanometer). The result of data was processed by Chi Square statistic test and Prevalence Odds Ratio (POR). The results of HDL research on hypertension found that from the 57 respondents, 34 respondents (56,9%) were hypertension and 25 respondents (43,9%) were hypertension whit HDL level at risk. Based on Chi-square statistical test, it was found that between HDL level and hypertension showed p value of 0.000 &lt;α (0,05). While, the POR value of the HDL variable was 10,000 CI 95% 2,865-34,899. The conclusion of this study was the HDL level correlated as a risk factor for hypertension incidence.

Promoting non-communicable disease risks in rural area: a Community and Family Health Care - inter professional education (CFHC-IPE) activity

Health is an aspect that could be viewed from various age groups and factors. Risk factors found during Community and Family Health Care-Inter Professional Education visits in Pondok 2, Widodomartani, Ngemplak are the habits of people who still lacking in controlling excessive consumption of sugar, salt, and oily foods. These may lead to many problems such as hypertension, diabetes mellitus and hypercholesterolemia. Based on the problem, our group held the community service activities focusing on health screening, particularly on the measurement of blood pressure, random blood glucose, and total cholesterol level. This activity aims to screen the community health condition and to raise health awareness and understanding. Therefore, people may start to take action improving their lifestyle in order to maintain their long term health status. This research is a retrospective study using secondary data obtained from health examination records at the time of community service. The health check-up was conducted on May 4, 2019. We utilize mannual mercury sphygmomanometer for blood pressure measurement and automatic skin prick test device for random blood glucose and total cholesterol level. During the health examination, we also counsel the subjects about healthy lifestyle. Sixteen people from the targeted community attended the activity. Half of the people had normal blood pressure; 1 person pre-hypertension; 4 persons stage I hypertension, and 3 persons stage II hypertension. For random blood glucose measurement, only 1 resulted in high random blood glucose whilst others were within normal limit. Total cholesterol level was examined to 9 people with history of hypercholesterolemia with the following results; 2 people had high level, 2 people had borderline-high level ,and the rest had normal level. Most of the people within the community had good health status. This kind of activity can be routinely conducted not only to screen community health status but also to promote health awareness.

Formulas to Explain Popular Oscillometric Blood Pressure Estimation Algorithms.

Oscillometry is the blood pressure (BP) measurement principle of most automatic cuff devices. The oscillogram (which is approximately the blood volume oscillation amplitude-external pressure function) is measured, and BP is then estimated via an empirical algorithm. The objective was to establish formulas to explain three popular empirical algorithms in the literature—the maximum amplitude, derivative, and fixed ratio algorithms. A mathematical model of the oscillogram was developed and analyzed to derive parametric formulas for explaining each algorithm. Exemplary parameter values were obtained by fitting the model to measured oscillograms. The model and formulas were validated by showing that their predictions correspond to measurements. The formula for the maximum amplitude algorithm indicates that it yields a weighted average of systolic and diastolic BP (0.45 and 0.55 weighting) instead of commonly assumed mean BP. The formulas for the derivative algorithm indicate that it can accurately estimate systolic and diastolic BP (<1.5 mmHg error), if oscillogram measurement noise can be obviated. The formulas for the fixed ratio algorithm indicate that it can yield inaccurate BP estimates, because the ratios change substantially (over a 0.5–0.6 range) with arterial compliance and pulse pressure and error in the assumed ratio translates to BP error via large amplification (>40). The established formulas allow for easy and complete interpretation of perhaps the three most popular oscillometric BP estimation algorithms in the literature while providing new insights. The model and formulas may also be of some value toward improving the accuracy of automatic cuff BP measurement devices.

Measuring the oscillometric method contribution to the measurement uncertainty of automated sphygmomanometers using a patient simulator

The sphygmomanometer is a widely used device for non-invasive blood pressure measurement. Systematic measurement errors and uncertainties can affect measurements, consequently, impacting diagnosis or medication. In order to maintain the conformity of the instruments, sphygmomanometers are usually under control of legal metrology demanding periodical verifications. Automated sphygmomanometers are based on the oscillometric method, measuring small changes of arterial blood pressure occurring in the cuff. Once pressure working standards are unable to generate the oscillometric pulses, verifications are performed on the sphygmomanometer on its manometer mode, disregarding the contribution of the oscillometric mode to the uncertainties. The present study investigates the contribution of the oscillometric method to the expanded measurement uncertainty. We used a patient simulator in four sphygmomanometers available in the market for consumers. The results show that the contribution of the oscillometric mode to the expanded uncertainty can be significant, varying from 0.16 to 1.56 mmHg and from 0.12 to 1.55 mmHg, for 100 and 150 mmHg, respectively. We also observed different contributions to the uncertainty for systolic and diastolic blood pressure.

Development of equations for converting random-zero to automated oscillometric blood pressure values

Background: This study aimed to collect data to compare blood pressure values between random-zero sphygmomanometers and automated oscillometric devices and generate equations to convert blood pressure values from one device to the other. Methods: Omron HEM-907, a widely used automated oscillometric device in many epidemiologic surveys and cohort studies, was compared here with random-zero sphygmomanometers. In total, 201 participants aged 40-79 years (37% men) were enrolled and randomly assigned to one of two groups, with blood pressure measurement first taken by automated oscillometric devices or by random-zero sphygmomanometers. The study design enabled comparisons of blood pressure values between random-zero sphygmomanometers and two modes of this automated oscillometric device (automated and manual), and assessment of effects of measurement order on blood pressure values. Results: Among all participants, mean blood pressure levels were the lowest when measured with random-zero sphygmomanometers compared with both modes of automated oscillometric devices. Several variables, including age and gender, were found to contribute to the blood pressure differences between random-zero sphygmomanometers and automated oscillometric devices. Equations were developed using multiple linear regression after taking those variables into account to convert blood pressure values by random-zero sphygmomanometers to automated oscillometric devices. Conclusions: Equations developed in this study could be used to compare blood pressure values between epidemiologic and clinical studies or identify shift of blood pressure distribution over time using different devices for blood pressure measurements.

Development of Blood Pressure Measurement Device Using The Curve Fitting Method

In present study, an automatic blood pressure measurement device was developed to perform measurement on the arm. The developed blood pressure measurement device was also used as display and control device. On this device, the curve fitting method, which is a very common numerical analysis method, was used to predict blood pressure. Resistor-Capacitor (RC) and digital filters were preferred to process and filter signal. Various tests were conducted on 21 individuals under the supervision of specialist health personnel. The obtained results indicate that a prediction accuracy of 94.67%, 92.51% and 97.68% can be achieved for systolic and diastolic blood pressure and heart rate values, respectively.

Validation of an automated home blood pressure measurement device in oldest-old populations.

Despite the wide use of automated devices for the self-measurement of home blood pressure (BP), no evidence is available regarding the accuracy of such devices in oldest-old populations. The aim of this study was to validate the accuracy of the automated oscillometric upper arm-cuff BP-monitoring device according to an international protocol in oldest-old individuals. In 35 participants aged over 85 years old, BP was measured on the same arm sequentially using a mercury sphygmomanometer (by two observers) and an Omron HEM-7080IC. The difference between the test device and observer measurements and associated factors were evaluated according to the International Organization for Standardization (ISO) 81060-2:2013 protocol. A total of 105 pairs (three pairs per participant) of the test device and observer BP measurements were obtained. The mean (±standard deviation: SD) differences in systolic BP (SBP) and diastolic BP (DBP) between the methods were -0.7 ± 7.1 and -1.1 ± 4.5 mmHg, respectively, and those for each participant were -0.7 ± 5.8 mmHg for SBP and -1.1 ± 4.1 mmHg for DBP; the device therefore fulfilled the requirements of the ISO protocol. In the multivariate analysis with the linear mixed model, the difference was associated with the cuff size for SBP and pulse pressure for DBP. The Omron HEM-7080IC passed the ISO requirements for oldest-old individuals aged 85 years or older. This device can be recommended for clinical and self/home use in oldest-old populations.

Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients.

Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and special populations. Reproducibility of such validation protocols is unknown. The aim of this study was to assess the inter-centre reproducibility of the European Society of Hypertension-International protocol (ESH-IP) in patients with large arm circumference at least 32 cm or obesity. Two independent validation studies were performed in parallel according to the ESH-IP protocol in two centres (Serbia and Armenia). The two studies were performed blindly and independently. The ESH-IP criteria were applied for the analysis. The OMRON RS7 wrist oscillometric devices were used in both studies. The distribution of the mean differences values of 5 or less, 10 or less and 15 mmHg or less between the observers and the device were for the Serbia team: 74, 95 and 98 for SBP and 78, 95 and 99 for DBP; and for the Armenia team: 86, 95 and 99 for SBP and 90, 99 and 99 for DBP. The mean differences (SD) of BP values between the observers and the device were for the Serbia team of 1.7 ± 4.8 mmHg for SBP and 1.2 ± 4.6 mmHg for DBP and for the Armenia team of -1.1 ± 4.2 mmHg for SBP and -0.3 ± 3.5 mmHg for DBP. This study showed that the ESH-IP validation protocol presents a good inter-centre reproducibility. The OMRON RS7 device showed similar results, fulfilling the validation criteria in two independent studies in patients with arm circumference at least 32 cm.

Abstract P2073: Blood Pressure Measurement: Should Technique Define Targets?

Background: Advancements in technology over the last decades have brought a mini-revolution into the centuries old technique of blood pressure (BP) assessment. Automated oscillometric BP devices allow not only to eliminate human error in BP readings, but more importantly they standardize the length of resting period and allow for unattended resting and BP measurement. BP thresholds for definition of hypertension as well as BP treatment targets are however largely derived from studies using mercury sphygmomanometers or non-automated oscillometric BP devices. Comparative studies addressing the effect of standardized length of unattended resting and presence versus absence of medical personnel during BP measurement per se are however lacking. Methods and Population: In this prospective randomized, crossover trial we compared office casual BP readings to BP readings after 5 minutes unattended resting and unattended BP measurement. Additionally, we compared 5 minutes unattended resting and unattended BP measurement with medical personnel presence during BP measurement. BP readings were obtained from the same arm on 2 different visits using an automated oscillometric BP device (Omron HEM 907XL), one pre- and second one post 24-hour ABPM. All patients followed at our regional, tertiary care hospital-based Hypertension Centre were eligible for this trial. Results: 90 adult patients were consented and 79 (men 54% and women 46%) completed all the measurements. Mean casual BP was 137. 1 ± 16.7, mean resting unattended BP was 130.1 ± 13.7, indicating difference of 7.0 + 10.0 mm Hg (p &lt; 0.0001). Mean resting attended BP was 129.3 ± 13.2 (not statistically different from completely unattended resting BP, difference - 2.7 [95% CI 1.4 -6.8] p = 0.18). Summary: Our study conclusively confirms that resting decreases blood pressure as assess from the difference between casual BP and BP obtained after 5 minutes of rest. More importantly, our study indicates that presence of medical personnel during BP measurements after initial 5 minutes unattended rest does not have a significant impact on overall resting BP readings. Conclusion: These data no superiority of fully automated devices versus semi-automated devices for BP measurements

Using the Characteristics of Pulse Waveform to Enhance the Accuracy of Blood Pressure Measurement by a Multi-Dimension Regression Model

With the advancement of wearable technology, many physiological monitoring instruments are gradually being converted into wearable devices. However, as a consumer product, the blood pressure monitor is still a cuff-type device, which does perform a beat-by-beat continuous blood pressure measurement. Consequently, the cuffless blood pressure measurement device was developed and it is based on the pulse transit time (PTT), although its accuracy remains inadequate. According to the cardiac hemodynamic theorem, blood pressure relates to the arterial characteristics and the contours of the pulse wave include some characteristics of the artery. Therefore, the purpose of this study was to use the contour characteristics of the pulses measured by photoplethysmography (PPG) to estimate the blood pressure using a linear multi-dimension regression model. Ten subjects participated in the experiment, and the blood pressure levels of the subjects were elevated by exercise. The results showed that the mean and standard deviation (mean ± SD) of the root mean square error of the estimated systolic and diastolic pressures within the best five parameters were 6.9 ± 2.81 mmHg and 4.0 ± 0.65 mmHg, respectively. Compared to the results that used one parameter, the PTT, for estimating the systolic and diastolic pressures, 8.2 ± 2.1 mmHg and 4.5 ± 0.79 mmHg, respectively, our results were better.

IMPROVED AGREEMENT OF A CUFFLESS 24 HOUR BLOOD PRESSURE MEASUREMENT DEVICE COMPARED TO CUFF-BASED STANDARD MEASUREMENT

Objective:A cuffless blood pressure (BP) measurement device (TestBP) using pulse-transit time (PTT) for beat-to-beat calculation of BP is in clinical use. Recently, we published data, demonstrating a significant difference between TestBP and a cuff-based standard 24 h BP device (RefBP) with signific