One size does not fit all: universal cuff overestimates oscillometric blood pressure in persons with large arm circumference.

OBJECTIVE: Some brachial cuffs for oscillometric blood pressure (BP) measurement are claimed to cover a wide range of upper-arm circumferences; however, their validation is rarely conducted. Our aim was to compare oscillometric BP measurements obtained with a universal cuff with those obtained with an appropriately sized cuff. METHODS: We utilised the Microlife B6 Connect monitor, conducting oscillometric BP measurements in a random sequence with both a universal cuff (recommended for arm circumferences from 22 to 42 cm) and an appropriately sized cuff (medium for circumference 22-32 cm and large for 32-42 cm). We included 91 individuals with an arm circumference of 22-32 cm and 64 individuals with an arm circumference of 32-42 cm. RESULTS: For arm circumferences > 32 cm, systolic and diastolic BP measured with the universal cuff was higher than that measured with the large cuff (systolic 6.4 mmHg, 95% confidence interval [CI]). 3.9-8.8, diastolic 2.4 mmHg, 95%CI, 1.2-3.7, p < 0.001 for both). Overestimation of BP with the universal cuff was statistically significant after correcting for the sequence of measurements. No statistical difference was found between the universal cuff and medium cuff for circumferences in the 22-32 cm range. The bladder size in the universal cuff matched the dimensions of the medium-sized cuff; however, the cuff was larger. CONCLUSION: Overestimation of BP measured with a universal cuff in persons with large arm circumferences is clinically important. It poses the risk of unnecessary initiation or intensification of antihypertensive medication in persons using the universal cuff.

What is the context?Clinical guidelines recommend individualisation of the size of the cuff used for blood pressure measurement according to the circumference of the upper arm.Many blood pressure monitors are sold with a single "universal" cuff claimed to cover a wide range of upper arm sizes.We compared blood pressure obtained with the Microlife B6 Connect monitor and a "universal" cuff with the results obtained with individual sized cuffs (medium size for arm circumference between 22 and 32 cm and large size for arm circumference between 32 and 42 cm).What is new?In persons with large upper arm circumference is the systolic blood pressure 6.4 mmHg higher and the diastolic blood pressure 2.4 mmHg higher with the universal cuff than with the individual-sized large cuff.What is the impact?The universal cuff overestimates blood pressure in persons with large arm circumference.

The 10 Hz dynamic response of a fluid-filled pressure monitoring system is a novel alternative to the fast flush test and indicative of unacceptable systolic pressure overshoot.

The standard method for qualitatively evaluating the dynamic response is to see if the gain of the amplitude spectrum curve approaches 1 (input signal = output signal) over the frequency band of the blood pressure waveform. In a previous report, Watanabe reported that Gardner's natural frequency and damping coefficient, which are widely used as evaluation methods, do not reflect the dynamic response of the circuit. Therefore, new parameters for evaluating the dynamic response of pressure monitoring circuits were desired. In this study, arterial pressure catheters with length of 30, 60, 150, and 210 cm were prepared, and a blood pressure wave calibrator, two pressure monitors with analog output and a personal computer were used to analyze blood pressure monitoring circuits. All data collection and analytical processes were performed using step response analysis program. The gain at 10 Hz was close to 1 and the systolic blood pressure difference was small in the short circuits (30 cm, 60 cm), and the gain at 10 Hz was 1.3-1.5 in the 150 cm circuit and over 1.7 in the 210 cm circuit. The difference in systolic blood pressure increased in proportion to the length of the circuit. It could also be inferred that the gain at 10 Hz should be less than 1.2 to meet a clinically acceptable blood pressure difference. In conclusion, the gain at 10 Hz is sufficiently useful as an indicator to determine the correct systolic blood pressure.

A comparison of invasive arterial blood pressure measurement with oscillometric non-invasive blood pressure measurement in patients with sepsis.

PURPOSE: This study aimed to compare non-invasive oscillometric blood pressure (NIBP) measurement with invasive arterial blood pressure (IBP) measurement in patients with sepsis. METHODS: We conducted a retrospective study to evaluate the agreement between IBP and NIBP using the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Paired blood pressure measurements of mean arterial pressure (MAP), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were compared using Bland-Altman analysis and paired Student's t test. We also focus on the effect of norepinephrine (NE) on the agreement between the two methods and the association between blood pressure and mortality during intensive care unit (ICU) stay. RESULTS: A total of 96,673 paired blood pressure measurements from 6060 unique patients were analyzed in the study. In Bland-Altman analysis, the bias (± SD, 95% limits of agreement) was 6.21 mmHg (± 12.05 mmHg, - 17.41 to 29.83 mmHg) for MAP, 0.39 mmHg (± 19.25 mmHg, - 37.34 to 38.12 mmHg) for SBP, and 0.80 mmHg (± 12.92 mmHg, - 24.52 to 26.12 mmHg) for DBP between the two techniques. Similarly, large limits of agreement were shown in different groups of NE doses. NE doses significantly affected the agreement between IBP and NIBP. SBP between the two methods gave an inconsistent assessment of patients' risk of ICU mortality. CONCLUSION: IBP and NIBP were not interchangeable in septic patients. Clinicians should be aware that non-invasive MAP was clinically and significantly underestimated invasive MAP.

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 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 ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.

OBJECTIVE: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. METHODS: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard. RESULTS: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ±â€…5.35 and 0.82 ±â€…5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively. CONCLUSION: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.

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.

Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms.

OBJECTIVE: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol. METHODS: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard. RESULTS: The mean BP difference between the device and the observers' reference measurements was 1.2 ±â€…2.0 mmHg for systolic BP and 1.0 ±â€…2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ±â€…8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle. CONCLUSIONS: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm.

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 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.

Visual assessment of Korotkoff sounds improves the accuracy of a validated professional automated auscultatory blood pressure monitor KOROT P3 Accurate.

OBJECTIVE: A novel automated auscultatory upper-arm cuff blood pressure (BP) monitor for office use (KOROT P3 Accurate, previously InBody BPBIO480KV), which displays Korotkoff sound curves for each BP reading was recently developed. This study investigated whether the review of Korotkoff sound curves by healthcare professionals further improves the accuracy of the device by identifying unreliable BP readings. METHODS: Three observers assessed independently the morphology of Korotkoff sound curves of BP measurements obtained during an ISO 81060-2:2018 validation study, and classified them as of good, fair, or poor quality (low amplitude or sound intensity, aberrant morphology, background noise, signal artifact, auscultatory gap, irregular rhythm). The observers were blinded to the study BP measurements. RESULTS: Korotkoff sound curves of 255 BP readings obtained in 85 individuals were analyzed (mean age 57.3 ±â€Š15.0 years, 53 men). Of the SBP readings 80.4/12.2/7.4% were classified as good/fair/poor, and DBP 76.9/12.2/10.9%. Inter-observer agreement in detecting poor-quality curves was 84.7/83.1% (systolic/diastolic). Of poor-quality curves, 10.5/60.7% (systolic/diastolic) clustered in the same individuals. The validation criterion 1 [mean test-reference BP difference ≤5 ±â€Š8 (SD) mmHg] was satisfied for readings with good (0.1 ±â€Š4.9/0.3 ±â€Š3.8 mmHg, systolic/diastolic) and fair-quality curves (-0.4 ±â€Š6.4/0.2 ±â€Š5.0), but not for poor-quality ones (2.7 ±â€Š8.8/3.6 ±â€Š8.1). By excluding poor-quality readings (40 of 255), criterion 1 of the validation study was improved (0.2 ±â€Š4.9/0.2 ±â€Š3.9 versus 0.3 ±â€Š5.5/0.6 ±â€Š4.7 mmHg). CONCLUSION: The visual assessment of Korotkoff sounds generated during automated auscultatory BP measurement by the KOROT P3 Accurate professional monitor identifies unreliable readings and further improves the device accuracy.

Accuracy of the OMRON HEM-7361T blood pressure monitor in the differentiation between atrial fibrillation and sinus rhythm.

OBJECTIVE: We investigated the accuracy of the OMRON HEM-7361T automated oscillometric blood pressure (BP) monitor in the differentiation between atrial fibrillation and sinus rhythm. METHODS: An approximately equal number of patients with persistent atrial fibrillation and individuals with sinus rhythm were recruited from outpatients and inpatients of Ruijin Hospital, Shanghai, China. BP was measured three times consecutively with a 30-s interval with the OMRON HEM-7361T automatic electronic BP monitor for atrial fibrillation detection. A hand-held single lead electrocardiogram device was used for simultaneous electrocardiogram recordings. RESULTS: The device accurately identified atrial fibrillation in 100 (99.0%) of the 101 patients, with only 1 patient incorrectly classified as non-atrial fibrillation. The device correctly identified 99 (95.2%) of the 104 participants with sinus rhythm as non-atrial fibrillation, with five participants incorrectly classified as atrial fibrillation. The device had a positive predictive value of 95.2%, negative predictive value of 99.0%, and overall accuracy of 97.1%. Among the six misclassified participants, one with atrial fibrillation had a heart rate of 65 beats/min, and four of the five participants with sinus rhythm had cardiac arrhythmias (atrial or ventricular premature beat in one participants, sinus tachycardia in one participant, and both arrhythmias in one participant). CONCLUSION: The OMRON HEM-7361T BP monitor is accurate in the differentiation between atrial fibrillation and sinus rhythm. Whether the device is sufficiently accurate in the differentiation between atrial fibrillation and other cardiac arrhythmias remains under investigation.

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.

Validation of the RBP-9801 oscillometric 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.

The aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor RBP-9801 developed for office and home 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). 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. A total of 105 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.3 ± 6.4/3.1 ± 5.8 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.24/5.03 mmHg (systolic/diastolic). The conclusion is that the RBP-9801 oscillometric device for office and home BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in the general population and can be recommended for clinic and self-use at home.

Optimización del desempeño del observador al medir la presión arterial en el consultorio: declaración de posición de la Comisión Lancet de Hipertensión / Optimizing observer performance of clinic blood Pressure measurement: a position statement from the Lancet Commission on Hypertension Group / Otimização do desempenho do observador na medição clínica da pressão arterial: posicionamento do Grupo da Lancet Commission on Hypertension

RESUMEN La hipertensión arterial es una causa modificable muy prevalente de enfermedades cardiovasculares, accidentes cerebrovasculares y muerte. Medir con exactitud la presión arterial es fundamental, dado que un error de medición de 5 mmHg puede ser motivo para clasificar incorrectamente como hipertensas a 84 millones de personas en todo el mundo. En la presente declaración de posición se resumen los procedimientos para optimizar el desempeño del observador al medir la presión arterial en el consultorio, con atención especial a los entornos de ingresos bajos o medianos, donde esta medición se ve complicada por limitaciones de recursos y tiempo, sobrecarga de trabajo y falta de suministro eléctrico. Es posible reducir al mínimo muchos errores de medición con una preparación adecuada de los pacientes y el uso de técnicas estandarizadas. Para simplificar la medición y prevenir errores del observador, deben usarse tensiómetros semiautomáticos o automáticos de manguito validados, en lugar del método por auscultación. Pueden ayudar también la distribución de tareas, la creación de un área específica de medición y el uso de aparatos semiautomáticos o de carga solar. Es fundamental garantizar la capacitación inicial y periódica de los integrantes del equipo de salud. Debe considerarse la implementación de programas de certificación de bajo costo y fácilmente accesibles con el objetivo de mejorar la medición de la presión arterial.(AU)

ABSTRACT High blood pressure (BP) is a highly prevalent modifiable cause of cardiovascular disease, stroke, and death. Accurate BP measurement is critical, given that a 5-mmHg measurement error may lead to incorrect hypertension status classification in 84 million individuals worldwide. This position statement summarizes procedures for optimizing observer performance in clinic BP measurement, with special attention given to low-tomiddle- income settings, where resource limitations, heavy workloads, time constraints, and lack of electrical power make measurement more challenging. Many measurement errors can be minimized by appropriate patient preparation and standardized techniques. Validated semi-automated/automated upper arm cuff devices should be used instead of auscultation to simplify measurement and prevent observer error. Task sharing, creating a dedicated measurement workstation, and using semi-automated or solar-charged devices may help. Ensuring observer training, and periodic re-training, is critical. Low-cost, easily accessible certification programs should be considered to facilitate best BP measurement practice.(AU)

RESUMO A hipertensão é uma causa altamente prevalente de doença cardiovascular, acidente vascular cerebral e morte. A medição precisa da pressão arterial (PA) é um aspecto crítico, uma vez que erros de mensuração da ordem de 5 mmHg podem levar a uma classificação incorreta do status de hipertensão em 84 milhões de pessoas em todo o mundo. O presente posicionamento resume os procedimentos para otimizar o desempenho do observador (o indivíduo responsável pela mensuração da PA) na mensuração clínica da PA, com atenção especial para contextos de baixa a média renda, onde recursos limitados, cargas de trabalho pesadas, restrições de tempo e falta de energia elétrica tornam mais desafiadora a tarefa de medir a PA. Muitos erros de mensuração podem ser minimizados pela preparação adequada do paciente e pelo uso de técnicas padronizadas. Para simplificar a mensuração e evitar erros do observador, devem-se utilizar dispositivos semiautomatizados ou automatizados validados, com manguito para braço, ao invés de auscultação. O compartilhamento de tarefas, a criação de uma estação de trabalho dedicada à mensuração e o uso de dispositivos semiautomatizados ou com carga solar podem ajudar. É essencial que seja assegurado o treinamento e retreinamento periódico do observador. Programas de certificação de baixo custo e de fácil acesso devem ser considerados para facilitar a adoção das melhores práticas na mensuração da PA.(AU)

Development and clinical validation of a non-invasive, beat-to-beat blood pressure monitoring device, compared to invasive blood pressure monitoring during coronary angiography / Desenvolvimento e validação clínica de equipamento para medida de pressão arterial não invasiva, batimento a batimento, comparado ao de pressão arterial invasiva durante procedimentos de angiocoronariografia

ABSTRACT Objective To develop and test a beat-to-beat blood pressure monitoring device during coronary angiography, and compare it with invasive blood pressure monitoring. Methods Twenty-eight patients with an indication for hemodynamic study were selected for this investigation, and kept in supine position. Before starting the coronary angiography, they were instructed about the use of the left radial bracelet for beat-to-beat blood pressure monitoring. Results There was a significant difference between the time required for the catheterization laboratory team to acquire the first invasive blood pressure reading and the time to obtain the first beat-to-beat reading (11.1±5.1 and 1.5±1.8, respectively; p<0.0001). The intraclass correlation coefficients (95%CI) of systolic and diastolic blood pressures were 0.897 (0.780-0.952) and 0.876 (0.734-0.942), indicating good reproducibility. Conclusion This study showed the process to develop a beat-to-beat blood pressure monitoring device. When compared to invasive blood pressure monitoring, there were no significant differences between the two methods. This technique may play a promising coadjuvant role when combined with invasive monitoring during coronary angiography procedures.

RESUMO Objetivo Desenvolver e validar um equipamento para monitorização de pressão arterial batimento a batimento, durante a realização de coronariografia, e comparar com as medidas de pressão arterial invasiva obtidas. Métodos Foram selecionados 28 pacientes com indicação de estudo hemodinâmico, que permaneceram em decúbito dorsal horizontal e, antes do início da coronariografia, foram orientados quanto ao uso da pulseira radial esquerda para monitorização da pressão arterial batimento a batimento. Resultados Houve diferença significativa entre o tempo necessário para a equipe de hemodinâmica adquirir a primeira medida da pressão arterial invasiva e o tempo da primeira medida da pressão arterial batimento a batimento (11,1±5,1 e 1,5±1,8, respectivamente; p<0,0001). Os coeficientes de correlação intraclasse (IC95%) da pressão arterial sistólica e da diastólica foram 0,897 (0,780-0,952) e 0,876 (0,734-0,942), indicando boa reprodutibilidade. Conclusão Este estudo demonstrou o processo de desenvolvimento de um equipamento para avaliação da pressão arterial batimento a batimento. Quando comparado com a pressão arterial invasiva, não foram encontradas diferenças significativas entre as duas medidas. Essa técnica pode constituir ferramenta coadjuvante promissora, associada à monitorização invasiva, durante procedimentos de coronariografia.

Análise das recomendações para a aferição da pressão arterial: revisão sistematizada da literatura / Analysis of recommendations for blood pressure assessment: systematic review of literature / Análisis de recomendaciones para la evaluación de la presión arterial: revisión sistematizada de la literatura

Objetivo: Identificar a melhor evidência científica sobre a correta aferição da pressão arterial. Métodos: revisão sistematizada da literatura com levantamento em ambiente virtual no período de setembro a dezembro de 2016, com textos publicados nas bases virtuais LILACS, PubMed, SciELO e Scopus. O material foi lido e as informações organizadas em quadro. Resultados: foram obtidos 12 artigos, oito abordavam a técnica de aferição em dois tempos, dois discutiram a eficácia de valores obtidos com aparelhos digitais, um debateu a eficácia do rastreômetro, e um comparou a aferição invasiva e não invasiva. Conclusão: o método indireto auscultatório é o mais utilizado para aferição de pressão arterial. Nesse procedimento inclui-se a técnica em dois tempos, considerada padrão ouro na acurácia dos valores e recomendada por normatizações. Recursos como aparelho digital e rastreômetro não apresentam a mesma acurácia, porém são importantes no diagnóstico da hipertensão. São alternativas para garantir a confiabilidade da medida das cifras: estabelecer protocolos para o procedimento, fornecer equipamentos adequados e educação continuada.(AU)

Objective: To identify the best scientific evidence on the correct measurement of arterial pressure. Methods: Systematic review of the literature with a virtual environment survey from September to December 2016, with texts published in the virtual databases LILACS, PubMed, SciELO and Scopus. The material has been read, and the information organized in frame. Results: Twelve articles were obtained, eight were on the technique of measurement in two times, two discussed the effectiveness of values obtained with digital devices, one discussed the effectiveness of the trace meter, and one compared the invasive and noninvasive measurement. Conclusion: the indirect auscultatory method is the most used for blood pressure measurement. This procedure includes the two-stroke technique, considered gold standard in the accuracy of values and recommended by standardization. Features such as digital apparatus and tracker do not present the same accuracy, but are important in the diagnosis of hypertension. They are alternatives to guarantee the reliability of the measurement of the numbers: to establish protocols for the procedure, to provide adequate equipment and continuous education.(AU)

Objetivo: conocer cuáles son las recomendaciones de las literaturas actuales para la correcta medición de la presión arterial sistémica. Metodo: revisión sistematizada de la literatura con levantamiento en ambiente virtual en el período de septiembre a diciembre de 2016, con textos publicados en las bases virtuales LILACS, PubMed, Scielo y Scopus. El material fue leído, y la información organizada en cuadro. Resultados: se obtuvieron 12 artículos, ocho abordaban la técnica de medición en dos tiempos, dos discutieron la eficacia de valores obtenidos con aparatos digitales, un debatió la eficacia del rastreo, y uno comparó la aferencia invasiva y no invasiva. Conclusión: el método indirecto auscultatorio es el más utilizado para la medición de la presión arterial. En este procedimiento se incluye la técnica en dos tiempos, considerada patrón oro en la exactitud de los valores y recomendada por normatizaciones. Los recursos como el dispositivo digital y el rastreo no presentan la misma exactitud, pero son importantes en el diagnóstico de la hipertensión. Son alternativas para garantizar la confiabilidad de la medida de las cifras: establecer protocolos para el procedimiento, suministrar equipos adecuados y educación continuada.(AU)

Conhecimento e habilidades sobre a medida da pressão arterial entre graduandos de enfermagem / Knowledge and skills about measuring blood pressure among nursing undergraduate students / Conocimientos y habilidades en la medición de la presión arterial entre los estudiantes de enfermeira

Objetivo: investigar os conhecimentos teórico e prático sobre a medida da pressão arterial entre graduandos de enfermagem. Método: estudo com abordagem mista, descritivo e exploratório, com corte transversal, realizado em 2015, com 40 graduandos de enfermagem de uma universidade pública de Minas Gerais, em três fases: observacional, levantamento do conhecimento teórico e grupo focal. Organização dos dados pela análise temática. Resultados: Da análise dos dados foi construído o mapa temático, As falhas na interrelação teoria-prática como tema central e seus subtemas, Barreiras para o aprendizado teórico, Barreiras para aprendizado prático, Barreiras no processo de acompanhamento e avaliação e Estratégias para melhoria do processo de ensino aprendizagem. Conclusão: As lacunas do conhecimento teórico e prático sobre a medida da pressão arterial contribuem para a obtenção de valores não fidedignos, o que compromete a segurança do paciente

Objetivo: investigar los conocimientos teórico y práctico sobre la medición de la presión arterial entre los estudiantes de enfermería. Método: estudio descriptivo con un enfoque mixto y exploratoria, con sección transversal en el año 2015, con 40 enfermería graduados de una pública Universidad de Minas Gerais, en tres fases: conocimiento teórico y observacional encuesta y grupos focales. Organización de datos para el análisis temático. Resultados: el análisis de los datos fue construido mapa temático, los defectos en la interelação teoría-práctica como un tema central y sus subtemas, barreras para el aprendizaje teórico, las barreras al aprendizaje prácticas barreras en el proceso de monitoreo y evaluación y estrategias para mejorar el proceso de enseñanza-aprendizaje. Conclusión: Las lagunas de conocimientos teóricos y prácticos sobre la medición de la presión arterial contribuyen a obtener valores confiables, que apuesta por la seguridad del paciente

Objective: The study's main goal was to assess the theoretical and practical knowledge about measuring blood pressure among nursing undergraduate students. Methods: It was a mixed approach study, both descriptive and explanatory, and a cohort study; it was performed in 2015 with 40 nursing undergraduate students from a Public University in Minas Gerais State. The research was carried out in three phases, as follows: observational, theoretical knowledge survey and focus group. Data was organized by thematic analysis. Results: Following the data analysis, it was built the thematic map, the interrelationship faults between theory and practice as the central theme and their subthemes, the theoretical learning barriers, the practical learning barriers, the barriers of following and evaluation process, and also the strategies to improve the teaching-learning process. Conclusion: The theoretical and practical knowledge gaps about blood pressure measurement contribute to non-reliable values in daily practice, which may compromise the patient safety

Confiabilidad de un monitor automatizado para la medición de la presión arterial / Reliability of an automatic monitor for blood pressure measurement

Background A correct blood pressure (BP) measurement is essential for the diagnosis and control of high BP. Aim: To evaluate the agreement and repeatability of BP measurements with the OMRON HEM-7320-LA device compared to a mercury sphygmomanometer. Material and Methods: A cross-sectional study comparing BP measurements made by two randomly selected trained nurses and an automatic oscillometric device. The mercurial sphygmomanometer was connected to the automated device via a "T" type connector and a dual-head stethoscope was used, allowing simultaneous measurements. The results were analyzed with one-factor analysis of variance, Bland-Altman's test, repeatability coefficient (RC), and intra-class correlation coefficient (ICC). Results: Forty-nine participants aged 56 ± 19 years were included. Nineteen had hypertension (38%). We did not observe a significant difference in either systolic (SBP) or diastolic blood pressure (DBP) pressure measurements between the observers and the device. The mean difference was −0.09 mmHg (95% confidence intervals (CI)-0.9 to 0.7) for SBP and −0.9 mmHg (95% CI −1.7 to −0.13) for DBP. The RC for SBP (6.2, 5.2 and 5.8 mmHg) and DBP (4.7, 4.2 y 5.2 mmHg) was similar between the observers and the device. The ICC for SBP was 0.990 (95% CI 0.983 to 0.995, p < 0.01) and 0.986 (95% CI 0.977 to 0.991, p < 0.01) for DBP. Conclusions: There was a high level of agreement and similar measurement repeatability in the measurements performed by the automatic device and the mercurial sphygmomanometer. No differences in BP measurements were observed.