Hypertension in Low- and Middle-Income Countries.

In recent decades low- and middle-income countries (LMICs) have been witnessing a significant shift toward raised blood pressure; yet in LMICs, only 1 in 3 are aware of their hypertension status, and ≈8% have their blood pressure controlled. This rising burden widens the inequality gap, contributes to massive economic hardships of patients and carers, and increases costs to the health system, facing challenges such as low physician-to-patient ratios and lack of access to medicines. Established risk factors include unhealthy diet (high salt and low fruit and vegetable intake), physical inactivity, tobacco and alcohol use, and obesity. Emerging risk factors include pollution (air, water, noise, and light), urbanization, and a loss of green space. Risk factors that require further in-depth research are low birth weight and social and commercial determinants of health. Global actions include the HEARTS technical package and the push for universal health care. Promising research efforts highlight that successful interventions are feasible in LMICs. These include creation of health-promoting environments by introducing salt-reduction policies and sugar and alcohol tax; implementing cost-effective screening and simplified treatment protocols to mitigate treatment inertia; pooled procurement of low-cost single-pill combination therapy to improve adherence; increasing access to telehealth and mHealth (mobile health); and training health care staff, including community health workers, to strengthen team-based care. As the blood pressure trajectory continues creeping upward in LMICs, contextual research on effective, safe, and cost-effective interventions is urgent. New emergent risk factors require novel solutions. Lowering blood pressure in LMICs requires urgent global political and scientific priority and action.

Home Blood Pressure Monitoring.

Home blood pressure monitoring provides important diagnostic information beyond in-office blood pressure readings and offers similar results to ambulatory blood pressure monitoring. Home blood pressure monitoring involves patients independently measuring their blood pressure with an electronic device, whereas ambulatory blood pressure monitoring involves patients wearing a portable monitor for 24 to 48 hours. Although ambulatory blood pressure monitoring is the diagnostic standard for measurement, home blood pressure monitoring is more practical and accessible to patients, and its use is recommended by the U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association. Home blood pressure monitoring generally results in lower blood pressure readings than in-office measurements, can confirm the diagnosis of hypertension after an elevated office blood pressure reading, and can identify patients with white coat hypertension or masked hypertension. Best practices for home blood pressure monitoring include using an appropriately fitting upper-arm cuff on a bare arm, emptying the bladder, avoiding caffeinated beverages for 30 minutes before taking the measurement, resting for five minutes before taking the measurement, keeping the feet on the floor uncrossed and the arm supported with the cuff at heart level, and not talking during the reading. An average of multiple readings, ideally two readings in the morning and again in the evening separated by at least one minute each, is recommended for one week. Home blood pressure readings can be used in hypertension quality measures.

QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010.

BACKGROUND: Hypertension is considered as a main risk factor for chronic kidney disease development and progression. Thus, the control and evaluation of this disease with new software and devices are especially important in patients who suffer from chronic kidney disease. OBJECTIVE: This study aimed to validate the QardioArm mobile device, which is used for blood pressure (BP) self-measurement in patients who suffer from chronic kidney disease, by following the European Society of Hypertension International Protocol 2 (ESH-IP2) guidelines. METHODS: A validation study was carried out by following the ESH-IP2 guidelines. A sample of 33 patients with chronic kidney disease self-measured their BP by using the QardioArm and Omron M3 Intellisense devices. Heart rate (HR), diastolic BP, and systolic BP were measured. RESULTS: The QardioArm fulfilled the ESH-IP2 validation criteria in patients who suffered from chronic kidney disease. CONCLUSIONS: Thus, this study is considered as the first validation using a wireless upper arm oscillometric device connected to an app to measure BP and HR meeting the ESH-IP2 requirements in patients who suffer from chronic kidney disease. New validation studies following the ESH-IP2 guidelines should be carried out using different BP devices in patients with specific diseases.

A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices.

BACKGROUND: Clinical guidelines recommend monitoring of blood pressure at home using an automatic blood pressure device for the management of hypertension. Devices are not often calibrated against direct blood pressure measures, leaving health care providers and patients with less reliable information than is possible with current technology. Rigorous assessments of medical devices are necessary for establishing clinical utility. OBJECTIVE: The purpose of our study was 2-fold: (1) to assess the validity and perform iterative calibration of indirect blood pressure measurements by a noninvasive wrist cuff blood pressure device in direct comparison with simultaneously recorded peripheral and central intra-arterial blood pressure measurements and (2) to assess the validity of the measurements thereafter of the noninvasive wrist cuff blood pressure device in comparison with measurements by a noninvasive upper arm blood pressure device to the Canadian hypertension guidelines. METHODS: The cloud-based blood pressure algorithms for an oscillometric wrist cuff device were iteratively calibrated to direct pressure measures in 20 consented patient participants. We then assessed measurement validity of the device, using Bland-Altman analysis during routine cardiovascular catheterization. RESULTS: The precalibrated absolute mean difference between direct intra-arterial to wrist cuff pressure measurements were 10.8 (SD 9.7) for systolic and 16.1 (SD 6.3) for diastolic. The postcalibrated absolute mean difference was 7.2 (SD 5.1) for systolic and 4.3 (SD 3.3) for diastolic pressures. This is an improvement in accuracy of 33% systolic and 73% diastolic with a 48% reduction in the variability for both measures. Furthermore, the wrist cuff device demonstrated similar sensitivity in measuring high blood pressure compared with the direct intra-arterial method. The device, when calibrated to direct aortic pressures, demonstrated the potential to reduce a treatment gap in high blood pressure measurements. CONCLUSIONS: The systolic pressure measurements of the wrist cuff have been iteratively calibrated using gold standard central (ascending aortic) pressure. This improves the accuracy of the indirect measures and potentially reduces the treatment gap. Devices that undergo auscultatory (indirect) calibration for licensing can be greatly improved by additional iterative calibration via intra-arterial (direct) measures of blood pressure. Further clinical trials with repeated use of the device over time are needed to assess the reliability of the device in accordance with current and evolving guidelines for informed decision making in the management of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03015363; https://clinicaltrials.gov/ct2/show/NCT03015363 (Archived by WebCite at http://www.webcitation.org/6xPZgseYS).

Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

The purpose of the study was to validate the ambulatory blood pressure monitoring (ABPM) device custo screen pediatric in children aged 3 to 12 years according to the International Protocol of the European Society of Hypertension (ESH-IP revision 2010). Thirty-three children were included and systolic and diastolic blood pressure measurements were performed according to the ESH-IP. The protocol was modified for children considering data from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS). The custo screen pediatric met all the requirements of the ESH-IP. The mean difference between the test device and the reference was -1.4 ± 3.0 mmHg for systolic blood pressure (SBP) and -0.7 ± 3.2 mmHg for diastolic blood pressure (DBP). For SBP and DBP, all 99 measurements were within the absolute difference of 10 mmHg between the test device and the reference. As to part 2 of the protocol, for DBP in all subjects, two out of three measurements were within 5 mmHg between the device and the standard, whereas for SBP in 32 of 33 subjects, two out of three measurements were within this range. CONCLUSION: The custo screen pediatric met all criteria of the ESH-IP review 2010, modified for children from 3 to about 12 years, and can be recommended for ABPM in children. What is Known: • Validation of blood pressure measuring devices is essential to provide patients with an accurate blood pressure measuring device. • The majority of devices has not been validated in children. What is New: • Prior to the present validation, study protocol adjustments of ESH-IP review 2010 for children were defined according to German Health Interview and Examination Survey for Children and Adolescents 2013 (KIGGS). • The custo screen pediatric test device met all criteria of ESH-IP revision 2010, modified for children, and can be recommended for ABPM in children aged 3 to about 12 years.

A tale of three cuffs: the hemodynamics of blood flow restriction.

INTRODUCTION: The blood flow response to relative levels of blood flow restriction (BFR) across varying cuff widths is not well documented. With the variety of cuff widths and pressures reported in the literature, the effects of different cuffs and pressures on blood flow require investigation. PURPOSE: To measure blood pressure using three commonly used BFR cuffs, examine possible venous/arterial restriction pressures, and measure hemodynamic responses to relative levels of BFR using these same cuffs. METHODS: 43 participants (Experiment 1, brachial artery blood pressure assessed) and 38 participants (Experiment 2, brachial artery blood flow assessed using ultrasound, cuff placed at proximal portion of arm) volunteered for this study. RESULTS: Blood pressure measurement was higher in the 5 cm cuff than in the 10 and 12 cm cuffs. Sub-diastolic relative pressures appear to occur predominantly at <60% of arterial occlusion pressure (AOP). Blood flow under relative levels of restriction decreases in a non-linear fashion, with minimal differences between cuffs [resting: 50.3 (44.2) ml min-1; 10% AOP: 42.0 (36.8); 20%: 33.6 (28.6); 30%: 23.6 (20.4); 40%: 17.1 (15.9); 50%: 12.5 (9.4); 60%: 11.5 (8.1); 70%: 11.4 (7.0); 80%: 10.3 (6.3); 90%: 7.9 (4.8); 100%: 1.5 (2.9)]. Peak blood velocity remains relatively constant until higher levels (>70% of AOP) are surpassed. Calculated mean shear rate decreases in a similar fashion as blood flow. CONCLUSIONS: Under relative levels of restriction, pressures from 40 to 90% of AOP appear to decrease blood flow to a similar degree in these three cuffs. Relative pressures appear to elicit a similar blood flow stimulus when accounting for cuff width and participant characteristics.

Comparison of arterial blood pressure measurements obtained invasively or oscillometrically using a Datex S/5 Compact monitor in anaesthetised adult horses.

OBJECTIVE: To assess agreement between noninvasive blood pressure (NIBP) oscillometrically-derived values from a multiparameter monitor (Datex Ohmeda S/5 Compact) with those obtained by invasive blood pressure (IBP) measurement in anaesthetised horses undergoing elective surgery. STUDY DESIGN: Prospective clinical study. ANIMALS: A total of 40 healthy adult horses. METHODS: Horses were anaesthetised with various anaesthetic protocols (based on clinical requirements). Depending on positioning, cannulation of the facial or lateral metatarsal artery was performed for IBP measurement. The cannula was connected via a transducer to the monitor. An appropriately sized NIBP cuff was placed around the tail base and connected to the same monitor. Systolic (SAP), mean (MAP) and diastolic (DAP) arterial blood pressures were continuously recorded from the invasive system, and at 3 minute intervals from the oscillometric system, throughout the surgical procedure using a Datex iCollect program. An appropriate arithmetic correction factor was applied to the oscillometric results where the cuff was not level with the heart. Assessment of the degree of agreement between invasive and noninvasive readings at each time point was performed using a modified Bland-Altman analysis. RESULTS: While in many horses there was relatively close correlation between the values obtained over time, there was substantial variability in individual animals which resulted in wide Bland-Altman limits of agreement. The oscillometric device over-reads by approximately 32, 23 and 22 mmHg, and under-reads by 26, 17 and 19 mmHg for SAP, MAP and DAP, respectively, compared with the IBP values. However, using the mean difference and standard deviation, the device conforms to American College of Veterinary Internal Medicine (ACVIM) standards. CONCLUSIONS AND CLINICAL RELEVANCE: Oscillometric blood pressure measurement using the Datex Ohmeda S/5 Compact multiparameter monitor conforms to ACVIM standards when the NIBP cuff is placed on the tail. However, because of the wide variability in measurements, we cannot recommend this technique to guide therapy in anaesthetised adult horses.

Validation of Omron HBP-1300 professional blood pressure monitor based on auscultation in children and adults.

UNLABELLED: BACKGROUnD: To determine whether the professional Omron HBP-1300 blood pressure (BP) monitor meets American Association for the Advancement of Medical Instrumentation (AAMI) accuracy standards in Chinese children and adults. METHOD: According to the AAMI protocol, simultaneous auscultatory measurements by two observers using a mercury manometer were obtained in participants using the Omron HBP-1300. Triple measurements were obtained after a minimum 5-min rest with a 1-min interval between adjacent measurements. RESULTS: A total of 85 participants submitted to 255 doctor-measured BP and 255 successful professional monitor readings. The initial auscultation systolic BP was <100 mmHg in 25 participants (29.4%), 100-160 mmHg in 53 participants (62.4%), and >160 mmHg in seven participants (8.2%). All of the simultaneous measurements agreed to within ± 10 mmHg, while 95% agreed to within ± 4 mmHg for both systolic and diastolic BP, and the consistency between two observers was satisfactory. The difference between the devices was -1.3 ± 3.6 mmHg for systolic BP and 0.7 ± 3.8 mmHg for diastolic BP and by AAMI method 1, which met this guideline. The average difference between two devices by AAMI method 2 was 1.4 ± 3.2 mmHg for systolic BP and 1.0 ± 3.9 mmHg for diastolic BP, which met this guideline. CONCLUSION: The professional BP monitor Omron HBP-1300 is desirable for measuring the BP for Chinese children and adults.

The CNAP™ Finger Cuff for Noninvasive Beat-To-Beat Monitoring of Arterial Blood Pressure: An Evaluation in Intensive Care Unit Patients and a Comparison with 2 Intermittent Devices.

BACKGROUND: Continuous and intermittent noninvasive measurements of arterial blood pressure (BP) have not been compared in the same population. In a large panel of intensive care unit patients, we assessed the agreement between CNAP™ (Continuous Noninvasive Arterial Pressure) finger cuff beat-to-beat monitoring of BP and reference intraarterial measurements. Two automated oscillometric brachial cuff devices were also tested: CNAP brachial cuff (used for CNAP finger cuff calibration) and an alternative device. The performance for detecting hypotension (intraarterial mean BP <65 mm Hg or systolic BP <90 mm Hg), response to therapy (therapy-induced increase in mean BP >10%), and hypertension (intraarterial systolic BP >140 mm Hg) was evaluated. We also assessed the between-calibration drift of CNAP finger cuff BP in specific situations: cardiovascular intervention or no intervention. METHODS: With each device, 3 pairs of noninvasive and intraarterial measurements were prospectively collected and analyzed according to current guidelines, the International Organization for Standardization (ISO) standard. The trending ability and drift of the CNAP finger cuff BP were assessed over a 15-minute observation period. RESULTS: In 182 patients, CNAP finger cuff and CNAP brachial cuff readings did not conform to ISO standard requirements (mean bias ± SD exceeding the maximum tolerated 5 ± 8 mm Hg), whereas the alternative automated brachial cuff succeeded for mean and diastolic BP. CNAP finger cuff trending ability was poor (concordance rate <70% over a 15-minute period) owing to a significant drift since calibration, especially if a cardiovascular intervention was performed (n = 75, -7.5 ± 10.2 mm Hg at the 14th minute, ie, before recalibration, versus -2.9 ± 7.9 mm Hg if no cardiovascular intervention occurred, n = 103, P = 0.0008). However, a similar and reliable performance was observed for the detection of hypotension with the CNAP finger cuff (within 4 minutes after calibration) and with the 2 automated brachial cuffs (area under the receiver operating characteristic curve ≥0.91, positive and negative likelihood ratios ≥5 and ≤0.20, respectively). The performance for the detection of response to therapy or of hypertension was slightly lower. CONCLUSIONS: In a large population of intensive care unit patients, CNAP did not fulfill the ISO criteria and exhibited a relevant between-calibration drift. However, CNAP measurements collected within 4 minutes after calibration were reliable for detecting hypotension, as were oscillometric devices, while providing beat-to-beat measurements. Interestingly, an alternative automated brachial cuff was more reliable than the native one, used for calibration. This information is important to clinicians using those devices and for further development of the CNAP technology.

The Accuracy of the CNAP® Device Compared with Invasive Radial Artery Measurements for Providing Continuous Noninvasive Arterial Blood Pressure Readings at a Medical Intensive Care Unit: A Method-Comparison Study.

BACKGROUND: In cases of intensive care unit (ICU) patients without an arterial line, noninvasive continuous blood pressure monitoring could be very beneficial. The CNAP® monitor (CNSystems Medizintechnik AG) provides noninvasive, beat-to-beat blood pressure (BP) estimates using the volume clamp method to measure finger arterial pressure calibrated to brachial pressure values. The aim of this study was to compare noninvasive BP estimates of the CNAP monitor with invasive blood pressure (IBP) measurements obtained via a radial arterial catheter in unselected medical ICU patients under routine clinical conditions. METHODS: In 40 adult patients, IBP and noninvasive CNAP blood pressure (CBP) were measured simultaneously for 30 minutes. Bland-Altman analysis accounting for repeated measurements revealed accuracy and precision of CBP toward IBP. Percentage errors were calculated using the summary measures method and tested for interchangeability. Trending analysis was assessed using 4-quadrant plots and polar plots, whereby each reported statistical calculation used the sample size of n = 40 patients. RESULTS: A total of 7200 measurement pairs of CBP and IBP were analyzed. For mean arterial pressure, accuracy ± precision resulted in 4.6 ± 6.7 mm Hg (limits of agreement -8.7 to 17.8 mm Hg) with a percentage error of 6.77% (95% confidence interval [CI], 6.57%-6.97%). Trending analysis of 3-minute intervals showed a concordance rate of 94.6% (95% CI, 94.0%-95.2%; exclusion zone 10%) and a polar concordance rate of 99.50% (95% CI, 99.48%-99.52%) for changes lying within 10% limits. CONCLUSIONS: The CNAP device provided feasible estimates of BP in unselected medical ICU patients under routine clinical conditions. Mean arterial pressure met interchangeability criteria for accuracy toward radial arterial pressure, as well as for percentage error, and showed good trending capabilities according to the Critchley predefined criteria.

[Mobile Health: IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices].

IEEE Std 1708-2014 breaks through the traditional standards of cuff based blood pressure measuring devices and establishes a normative definition of wearable cuffless blood pressure measuring devices and the objective performance evaluation of this kind of devices. This study firstly introduces the background of the new standard. Then, the standard details will be described, and the impact of cuffless blood pressure measuring devices with the new standard on manufacturers and end users will be addressed.

Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis.

BACKGROUND: Continuous noninvasive arterial pressure monitoring devices are available for bedside use, but the accuracy and precision of these devices have not been evaluated in a systematic review and meta-analysis. METHODS: The authors performed a systematic review and meta-analysis of studies comparing continuous noninvasive arterial pressure monitoring with invasive arterial pressure monitoring. Random-effects pooled bias and SD of bias for systolic arterial pressure, diastolic arterial pressure, and mean arterial pressure were calculated. Continuous noninvasive arterial pressure monitoring was considered acceptable if pooled estimates of bias and SD were not greater than 5 and 8 mmHg, respectively, as recommended by the Association for the Advancement of Medical Instrumentation. RESULTS: Twenty-eight studies (919 patients) were included. The overall random-effect pooled bias and SD were -1.6 ± 12.2 mmHg (95% limits of agreement -25.5 to 22.2 mmHg) for systolic arterial pressure, 5.3 ± 8.3 mmHg (-11.0 to 21.6 mmHg) for diastolic arterial pressure, and 3.2 ± 8.4 mmHg (-13.4 to 19.7 mmHg) for mean arterial pressure. In 14 studies focusing on currently commercially available devices, bias and SD were -1.8 ± 12.4 mmHg (-26.2 to 22.5 mmHg) for systolic arterial pressure, 6.0 ± 8.6 mmHg (-10.9 to 22.9 mmHg) for diastolic arterial pressure, and 3.9 ± 8.7 mmHg (-13.1 to 21.0 mmHg) for mean arterial pressure. CONCLUSIONS: The results from this meta-analysis found that inaccuracy and imprecision of continuous noninvasive arterial pressure monitoring devices are larger than what was defined as acceptable. This may have implications for clinical situations where continuous noninvasive arterial pressure is being used for patient care decisions.

Accuracy of invasive arterial pressure monitoring in cardiovascular patients: an observational study.

INTRODUCTION: Critically ill patients and patients undergoing high-risk and major surgery, are instrumented with intra-arterial catheters and invasive blood pressure is considered the "gold standard" for arterial pressure monitoring. Nonetheless, artifacts due to inappropriate dynamic response of the fluid-filled monitoring systems may lead to clinically relevant differences between actual and displayed pressure values. We sought to analyze the incidence and causes of resonance/underdamping phenomena in patients undergoing major vascular and cardiac surgery. METHODS: Arterial pressures were measured invasively and, according to the fast-flush Gardner's test, each patient was attributed to one of two groups depending on the presence (R-group) or absence (NR-group) of resonance/underdamping. Invasive pressure values were then compared with the non-invasive ones. RESULTS: A total of 11,610 pulses and 1,200 non-invasive blood pressure measurements were analyzed in 300 patients. Ninety-two out of 300 (30.7%) underdamping/resonance arterial signals were found. In these cases (R-group) systolic invasive blood pressure (IBP) average overestimation of non-invasive blood pressure (NIBP) was 28.5 (15.9) mmHg (P <0.0001) while in the NR-group the overestimation was 4.1(5.3) mmHg (P < 0.0001). The mean IBP-NIBP difference in diastolic pressure in the R-group was -2.2 (10.6) mmHg and, in the NR-group -1.1 (5.8) mmHg. The mean arterial pressure difference was 7.4 (11.2) mmHg in the R-group and 2.3 (6.4) mmHg in the NR-group. A multivariate logistic regression identified five parameters independently associated with underdamping/resonance: polydistrectual arteriopathy (P = 0.0023; OR = 2.82), history of arterial hypertension (P = 0.0214; OR = 2.09), chronic obstructive pulmonary disease (P = 0.198; OR = 2.61), arterial catheter diameter (20 vs. 18 gauge) (P < 0.0001; OR = 0.35) and sedation (P = 0.0131; OR = 0.5). The ROC curve for the maximal pressure-time ratio, showed an optimum selected cut-off point of 1.67 mmHg/msec with a specificity of 97% (95% CI: 95.13 to 99.47%) and a sensitivity of 77% (95% CI: 67.25 to 85.28%) and an area under the ROC curve by extended trapezoidal rule of 0.88. CONCLUSION: Physicians should be aware of the possibility that IBP can be inaccurate in a consistent number of patients due to underdamping/resonance phenomena. NIBP measurement may help to confirm/exclude the presence of this artifact avoiding inappropriate treatments.

Validating the accuracy of Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population.

PURPOSE: The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol. METHODS: The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions. RESULTS: In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ±â€…6.17/3.6 ±â€…5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ±â€…4.82 mmHg for systolic BP and 3.6 ±â€…4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled. CONCLUSION: The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.

Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).

OBJECTIVE: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy. METHODS: The requirements of 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) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm. RESULTS: Data from 85 individuals were analyzed [mean age: 56.4 ±â€…16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ±â€…8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg). CONCLUSION: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.

Validation of the Mindray VS9 Vital Signs Monitor in a combined adult and pediatric population according to ISO Standard 81060-2:2018.

We aimed to validate the accuracy of the Mindray VS9 Vital Signs Monitor, which features the Mindray TrueBP inflation algorithm for oscillometric blood pressure (BP) measurement, to check if it complies with the International Organization for Standardization Standard (ISO 81060-2:2018) in a combined adult and pediatric population. A total of 86 participants, including both adult and pediatric subjects, were recruited. The distribution of their ages, gender, BPs and limb sizes all complied with the requirement of the ISO standard. The inflation and deflation algorithms were validated independently using the same-arm sequential BP measurement method. For each subject, the BP was first determined by two independent observers using a mercury sphygmomanometer (R1). The BP of the subject was then determined by the third observer using the test equipment (T1). Then, using a mercury sphygmomanometer, two independent observers were asked to determine the subject's BP (R2) again. R1-T1-R2 were considered a valid pair of data. This cycle continued until 3 pairs of valid data were achieved. We collected 258 pairs of valid BP data for the validation of the inflation and deflation algorithms respectively. For validation Criterion 1, the mean ± SD of the differences between the readings obtained from the test device and reference BP was 0.0 ±â€…6.6/-1.8 ±â€…7.1 mmHg (systolic/diastolic) when the deflation algorithm was used, and 2.4 ±â€…6.3/ 0.3 ±â€…6.9 mmHg (systolic/diastolic) when the inflation algorithm was used. For validation Criterion 2, the SD of the averaged BP differences between the test device and the reference BP per subject was 5.35/6.33 mmHg (systolic/diastolic) when the deflation algorithm was used, and 5.17/5.75 mmHg (systolic/diastolic) when the inflation algorithm was used. The VS9 Vital Signs Monitor fulfilled all the criteria in the ISO Standard. Moreover, the inflation algorithm had a shorter Measure Time (by 7-21 s) and lower maximum inflation pressure (by 9.7-22 mmHg). The VS9 Vital Signs Monitor fulfilled all the requirements of the ISO Standard (ISO 81060-2:2018) in a combined adult and pediatric population and is recommended for clinical use.

Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard.

OBJECTIVE: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard. METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results. RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ±â€…5.60 mmHg for SBP and -0.09 ±â€…6.10 mmHg for DBP for the iFAST mode, and -2.04 ±â€…5.55 mmHg for SBP and -0.79 ±â€…5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP. CONCLUSION: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.

Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020).

To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.

Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).

OBJECTIVE: The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the 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) at rest and during dynamic exercise. METHOD: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large). RESULTS: For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ±â€…SD of the differences between the test device and reference BP readings was 0.5 ±â€…6.2/-0.2 ±â€…5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N  = 35), the mean difference was 0.4 ±â€…5.9/-1.1 ±â€…5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error. CONCLUSION: These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.

Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.

Purpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol. Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions. Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled. Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.