Sequential Blood Pressure Measurements Research Articles

PP.04.03] VALIDATION OF BLOOD PRESSURE MONITORS IN PEDIATRIC POPULATION

Objective: The prevalence of hypertension in children and adolescents is increasing. Electronic devices are frequently used in children for ambulatory, home and office blood pressure (BP) measurement. However, electronic BP monitors that have been successfully validated in adults might not be accurate in children, and separate validation is required. A review of validation studies in young individuals was performed, aiming to identify protocol violations, divergences and adaptations. Design and method: Published validation studies (PubMed) performed in infants, children and adolescents from 1996 till the end of 2015 using any of the established validation protocols (British Hypertension Society [BHS] protocol; US AAMI and/or International Standardization Organization [ISO]; European Society of Hypertension International Protocol [ESH-IP]) were included. All aspects of the protocols’ procedure were scrutinized using a standard checklist. Results: 37 studies were identified (sample size 18–529 subjects). Sixteen studies (43%) used the BHS, 16 (43%) the AAMI and/or ISO and 5 (14%) the ESH-IP. The number of studies published per year were 4-5-2-5-2-5-8-3-3 for years 1996-98-2000-06-08-09-11-12-15 respectively. 21 studies (57%) tested devices for clinic/hospital use, 11 (30%) for ambulatory and 5 (13%) for home use. 26 studies reported a ’pass’ result for systolic and diastolic BP, 7 ’fail’ for systolic and diastolic BP, and 4 a ’fail’ only for diastolic BP. Two studies included infant/neonatal populations, 31 studies included children and adolescents and 4 included also adults. Same-arm sequential BP measurement procedure was applied in 24 studies (65%), same-arm simultaneous measurements in 6 studies and intra-arterial method in 2 studies (3 articles did not report the method used). Fourteen studies used Korotkoff sound V to define diastolic BP, 2 studies used K4, and 2 used K4 or K5 depending on the subject (9 articles did not report the sound used). Conclusions: The validation of BP monitors in children has specific methodological issues and challenges which are not encountered in adults. The peer review process of scientific journals often misses important deficiencies of validation studies. Few validation studies of BP monitors in children have been published and more research is needed.

PP.08.13] CLINICAL VALIDATION OF A NOVEL CUFFLESSS BLOOD PRESSURE MONITOR

Objective: A pocket-size cuffless device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense). The device requires individualized initial calibration based on a reference arm BP measurement performed by using a validated arm BP monitor, and calculates systolic and diastolic BP through the radial pulse and the ECG using electrodes and one force-sensor. An interim analysis of a clinical validation study was performed. Design and method: Three BP measurements were taken simultaneously by 2 observers (Y-tube connected mercury sphygmomanometers) and the last 2 were averaged for device calibration in each individual. According to the validation protocol, 5 same arm sequential BP measurements were taken by the observers (mercury sphygmomanometers) alternately with 4 test device measurements. Validation criteria of the American National Standards Institute / Association for the Advancement of Medical Instrumentation / International Organization for Standardization (ANSI/AAMI/ISO) 2013 and the European Society of Hypertension International Protocol (ESH-IP) 2010 protocol were applied. Results: To date 64 subjects have been recruited and 43 with complete BP data were included in the analysis (mean age 48.4 ± 10.9 [SD], men 72.1%, entry BP range 105-174/54-126 mmHg [systolic/diastolic]). For ANSI/AAMI/ISO protocol criteria, the mean device-observers difference was for systolic BP 2.3 ± 6.7 mmHg and diastolic 1.1 ± 4.0 mmHg (criterion 1). The estimated SDs (inter-subject variability) were 5.93 and 3.68 respectively (criterion 2). For the ESH-IP protocol criteria, the within 5, 10 and 15 mmHg device-observer systolic BP differences were 67%, 94% and 99% respectively and diastolic 89%, 99% and 100% (criterion 1). Of 43 subjects 31 had 2 of their 3 systolic BP differences within 5 mmHg and 41 for diastolic BP (criterion 2). In addition, 2 subjects had no systolic BP differences within 5 mmHg and 1 for diastolic (criterion 2). Conclusions: This interim analysis suggests that the cuffless BP monitor Freescan achieves a ’pass’ grade according to both the ANSI/AAMI/ISO 2013 and ESH-IP 2010 validation protocols. This novel new technology has promising potential for portable self-monitoring of BP by patients with hypertension.

Simultaneous Compared With Sequential Blood Pressure Measurement Results in Smaller Inter‐Arm Blood Pressure Differences

There are currently few recommendations on how to assess inter-arm blood pressure (BP) differences. The authors compared simultaneous with sequential measurement on mean BP, inter-arm BP differences, and within-visit reproducibility in 240 patients stratified according to age (<50 or ≥60 years) and BP (<140/90mm Hg or ≥140/90mm Hg). Three simultaneous and three sequential BP measurements were taken in each patient. Starting measurement type and starting arm for sequential measurements were randomized. Mean BP and inter-arm BP differences of the first pair and reproducibility of inter-arm BP differences of the first and second pair were compared between both methods. Mean systolic BP was 1.3±7.5mm Hg lower during sequential compared with simultaneous measurement (P<.01). However, the first sequential measurement was on average higher than the second, suggesting an order effect. Absolute systolic inter-arm BP differences were smaller on simultaneous (6.2±6.7/3.3±3.5mm Hg) compared with sequential BP measurement (7.8±7.3/4.6±5.6mm Hg, P<.01 for both). Within-visit reproducibility was identical (both r=0.60). Simultaneous measurement of BP at both arms reduces order effects and results in smaller inter-arm BP differences, thereby potentially reducing unnecessary referral and diagnostic procedures.

Validation of the Omron HEM-7201 upper arm blood pressure monitor, for self-measurement in a high-altitude environment, according to the European Society of Hypertension International Protocol revision 2010.

Few studies have been conducted on blood pressure monitors and their use at high altitude. This study is the first to evaluate an automated blood pressure device at high altitude following a standard validation protocol. The Omron HEM-7201 upper arm automatic blood pressure monitor was tested for accuracy in Lhasa, Tibet, China (3650 m above sea level) according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2). Thirty-three participants received 9–10 sequential blood pressure measurements alternating from a mercury sphygmomanometer and the device. The mean device-observer measurement difference was 1.0 ± 5.9 mmHg for systolic blood pressure (SBP) and −3.1 ± 4.6 mmHg for diastolic blood pressure (DBP). Of the 99 measurement pairs analyzed, 72, 90, and 97 device readings were within 5, 10, and 15 mmHg, respectively, of the observer measurements for SBP, and 68, 92, and 99 readings for DBP. The number of participants with at least two out of three measurements within 5mmHg was 27 for SBP and 25 for DBP. Three participants had no measurements within 5 mmHg for SBP or DBP. The Omron HEM-7201 passes the ESH-IP2 validation criteria and can therefore be recommended for use in adults in this setting.

Accuracy of oscillometric blood pressure monitors for the detection of atrial fibrillation: a systematic review

Atrial fibrillation (AF) is a significant risk factor for stroke and early detection of AF may help to identify patients in need of treatment. Automated blood pressure (BP) monitors with implemented AF or arrhythmia detection systems may be a useful tool for early diagnosis of AF. A systematic review (Medline/PubMed, Embase, Cochrane) of studies was performed to assess the accuracy of modified BP monitors (for diagnosing AF). A total of five studies (four tests in the physician’s office and one at home) were selected. For the most accurate AF detection, three sequential BP measurements should be performed. Direct comparison against a 12-lead ECG showed that the highest sensitivity, 97% (95% CI: 94–100%), for detecting AF was obtained when three readings were assessed with two or three AF-positive readings. The highest specificity (97%) was obtained when performing three measurements, of which all three must be AF positive. The modified BP monitor (Microlife Corporation, Taipei, Taiwan) has high potential in improving AF screening.

Validation of a solar powered blood pressure device, suitable for use in low resource settings

Hypertensive diseases in pregnancy are a significant cause of morbidity and mortality, particularly in low resource settings (LRS). Pre-eclampsia and eclampsia alone claim up to 50 000 women's lives globally...

Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents

PurposeTo validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol.MethodsForty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2.ResultsThe mean (±SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.85±1.65 mmHg for systolic BP (SBP) and 4.41±3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean±SD below 5±8 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed.ConclusionAlthough the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

A new technique for simultaneous validation of two manual nonmercury auscultatory sphygmomanometers (A&amp;D UM-101 and Accoson Greenlight 300) based on the International protocol

Auscultatory nonmercury manual devices seem good alternatives for the mercury sphygmomanometers in the clinic and for research settings, but individual internal validation of each device is time-consuming. The aim of this study was to validate a new technique capable of testing two devices simultaneously, based on the International protocol of the European Society of Hypertension. The concept of the new technique is to measure blood pressure alternatively by two observers using a mercury sphygmomanometer and by two observers using the A&D UM-101 and Accoson Greenlight 300 devices, connected by Y-tube to obtain simultaneous readings with both nonmercury devices. Thirty-three participants were enrolled (mean age 47.2±14.0 years). Nine sequential blood pressure measurements were performed for each participant. Both devices passed phase 1 using 15 participants. In phase 2.1 (n=33), on a maximum of 99 measurements, the Accoson device produced 81/95/99 measurements within 5/10/15 mmHg for systolic blood pressure (SBP) and 87/98/99 for diastolic blood pressure (DBP). The A&D device produced 86/96/99 for SBP and 94/99/99 for DBP. In phase 2.2 (n=33), 30 participants had at least 2 out of 3 SBP obtained with Accoson device within 5 mmHg of the mercury device, as compared with 29 of 33 participants with the A&D device. For DBP, this was 33 of 33 participants for both devices. Both the nonmercury devices passed the International protocol. The new technique of simultaneous device testing using a Y-tube represents a time saving application of the International protocol.

Validação do esfigmomanômetro aneroide Missouri para medir pressão arterial em pacientes com câncer

Auscultatory mercury sphygmomanometers to measure blood pressure (BP) have been banned from health services because of risk of pollution and environmental accidents with mercury. Aneroid appliances could be an alternative. To validate the Missouri aneroid device for blood pressure measurement in cancer patients according to the protocol of the European Society of Hypertension (ESH). 33 patients hospitalized or under outpatient care at the Cancer Institute of the State of São Paulo, FMUSP, were evaluated. Three trained and blinded observers performed nine sequential blood pressure measurements interspersed with the mercury sphygmomanometers. The differences between the values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) of the test device with the mercury sphygmomanometer were classified according to the ESH protocol. The Missouri equipment underwent all three phases required by the ESH Protocol for SBP and DBP, and it was approved in all of the phases. The average difference between the test device and the mercury sphygmomanometer was 0.62 (SD = 4.53) and 0.06 (SD = 6.57) mmHg for SBP and DBP, respectively. No association was found between the differences in BP measurements with sex, age, body mass index and arm circumference and length. The results revealed that the aneroid Missouri device meets ESH accuracy recommendations for the measurement of SBP and DBP, and it can be used to replace the mercury sphygmomanometer.

Development and validation of a blinded hybrid device according to the European Hypertension Society protocol: Nissei DM-3000

Both automated and auscultatory blood pressure (BP) devices have their strengths and accuracy limitations. Hybrid devices, such as the Nissei DM-3000, are mercury free and provide both automated and auscultatory measurement modes. The aim of this study was to validate all measurement modes of the Nissei DM-3000 device according to the European Society of Hypertension (ESH) protocol, as well as to develop and validate a 'blinded' auscultatory measurement mode. Different measurement modes were developed and evaluated in separate studies. Nine sequential same-arm BP measurements were taken alternating between simultaneous mercury sphygmomanometer readings and the device. The latter seven measurements were analysed according to the requirements of the ESH protocol. All measurement modes of the device passed the ESH protocol. The blinded mode achieved the best results with a mean difference+/-s.d. of -0.1+/-2.6 and 0.04+/-2.4 mm Hg for systolic BP (SBP) and diastolic BP (DBP), respectively. The most accurate auscultatory measurement results were obtained with a deflation rate of 2.5 mm Hg s(-1) achieving a mean difference+/-s.d. of -0.6+/-4.4 (for SBP) and -1.4+/-2.8 mm Hg (for DBP). The automated mode achieved a mean difference+/-s.d. of -0.8+/-6.0 (SBP) and 0.8+/-4.8 mm Hg (DBP). The Nissei DM-3000 device is a suitable replacement for the mercury sphygmomanometer.

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients

Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.

Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults

Electronic blood pressure (BP) measurement devices are the preferred choice of patients owing to their user-friendly nature; however, there is a requirement to investigate the accuracy and reliability of these devices. The objective of this study is to evaluate the accuracy of the Omron M6 upper-arm BP device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. One hundred and twenty-one patients, older than 30 years of age, were studied and classified on the basis of the range of the International Protocol. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. A total of 33 participants were selected for each validation study. During the validation study, 99 measurements were performed on 33 participants for comparison. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Having a two-fold purpose, this study was conducted on both adult and obese adult patients. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.1+/-4.0 mmHg for systolic BP (SBP) and -0.5+/-3.5 mmHg for diastolic BP (DBP) in the adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 88, 96, and 97 for SBP, and 88, 98, and 99 for DBP were <5, <10, and <15 mmHg, respectively. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.7+/-4.8 mmHg for SBP and -0.8+/-4.3 mmHg for DBP in the obese adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 82, 90, and 97 for SBP, and 80, 97, and 99 for DBP were <5, <10, and <15 mmHg, respectively. It was found that the Omron M6 automatic monitor, which measures BP at the upper arm, produced results in accordance with the criteria of phases 2.1 and 2.2 in both SBP and DBP, when applied to adults and to obese adults. It was concluded that the Omron M6 device, which measures BP at the upper arm, was deemed to be in accordance with the International Protocol criteria and can be recommended for use by adults and obese adults.

Validation of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure measuring devices in adults according to the International Protocol

A variety of automatic blood measurement devices with diverse features have been introduced to the medical markets recently. Among these devices, models that measure at the wrist have become increasingly popular in self measurements. The objective of this study was to evaluate the accuracy of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure devices against the mercury sphygmomanometer in adults according to the International Protocol criteria. Fifty-four patients over 30 years of age were studied and classified based on the International Protocol range. Blood pressure measurements at the wrist with the Samsung SBM-100A and Microlife BP 3BU1-5 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with randomly distributed arm circumferences were selected for both of the validation studies. During each validation study, 99 measurements were obtained for comparison from 33 participants. The first phase was performed on 15 participants and if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the device-sphygmomanometer were 0.9+/-9.2 and -2.7+/-9.3 mmHg for systolic blood pressure and -1.4+/-8.0 mmHg and 1.4+/-5.7 for diastolic blood pressure in the Samsung and Microlife study groups, respectively. The Samsung SBM-100A passed Phase 1 in 15 participants. Despite the fact that Microlife BP 3BU1-5 passed Phase 1 for diastolic pressure, it failed according to the systolic pressure criteria. Eighteen patients were added and Phase 2 was continued, in which Samsung SBM-100A failed to meet the criteria of Phases 2.1 and 2.2 for adults in systolic and diastolic blood pressure. It was found that the Microlife BP 3BU1-5 does not meet the criteria of either of Phases 2.1 and 2.2 for systolic blood pressure and Phase 2.2 for diastolic blood pressure. In this study, Samsung SBM-100A and Microlife blood pressure 3BU1-5 wrist blood pressure monitoring devices were found to be incompetent to meet the criteria of the International Protocol and it has not been possible to suggest any one of them for clinical use in adults.

Validation of the Braun BP 3550 wrist blood pressure measuring device with a position sensor and an EasyClick cuff according to the International Protocol in adults

Among the electronic blood pressure measuring devices used for self-measurement of blood pressure by patients, models that measure at the wrist are becoming increasingly popular. Validation studies done with these equipments, however, are quite few. The objective of this study was to evaluate the accuracy of the Braun BP 3550 wrist blood pressure device against the mercury sphygmomanometer in adults according to the International Protocol criteria. Fifty-four patients over 30 years of age were studied and classified on the basis of the range of the International Protocol. Blood pressure measurements at the wrist with the Braun BP 3550 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 individuals with randomly distributed arm circumferences were selected for the validation study. During the validation study, 99 measurements were obtained for comparison from 33 individuals. The first phase was performed on 15 individuals and if the device passed this phase, 18 more individuals were selected. Mean discrepancies and standard deviations of the device sphygmomanometer were 0.4+/-8.1 mmHg for systolic blood pressure and 2.1+/-5.8 mmHg for diastolic blood pressure in the study group. The device passed phase 1 in 15 individuals. In phase 2.1, from the total 99 comparisons, 65, 84 and 91 for systolic blood pressure and 62, 91 and 98 for diastolic blood pressure were <5, <10 and <15 mmHg, respectively. In phase 2.2, 23 individuals had at least two of the differences within 5 mmHg, and two had no differences within 5 mmHg for systolic blood pressure. In terms of diastolic blood pressure, 23 individuals had at least two of the differences within 5 mmHg and three had no differences within 5 mmHg. Braun BP 3550 passed phases 2.1 and 2.2 in the adult participants. The Braun BP 3550 wrist blood pressure device passed according to the International Protocol criteria and can be recommended for use in adults. Deviation from the average value, however, was greater in patients with high systolic blood pressure as compared with those with lower blood pressure.

Validation of a non-mercury digital auscultatory device with manual pressure registration (PMS Mandaus)

To assess the clinical accuracy of a non-mercury digital auscultatory device (PMS Mandaus) with manual pressure registration in an adult population. The accuracy of the device was assessed by predefined criteria (European Society of Hypertension protocol) in 33 study participants recruited from among patients and staff in a teaching hospital. A series of same-arm sequential blood pressure measurements were taken: first, two observers taking simultaneous mercury readings, followed by a reading with the device. A total of seven readings were taken from each participant in the sitting position. The data were then analysed according to the European Society of Hypertension protocol and the criteria of the Association for the Advancement of Medical Instrumentation. The device fulfilled the criteria of the European Society of Hypertension protocol, achieving a pass for both systolic and diastolic pressure. The device also passed the Association for the Advancement of Medical Instrumentation standard (the mean to be within 5+/-8 mmHg) with the mean differences being -3.2+/-3.8 mmHg for systolic blood pressure and -1.8+/-2.9 mmHg for diastolic blood pressure. The device performed in a satisfactory manner according to the European Society of Hypertension and the Association for the Advancement of Medical Instrumentation criteria. The systematic under-recording related to the delay of manual pressure registration is not sufficient to preclude clinical use.

Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly

The market for wrist devices for self-measurement is growing and these devices are becoming popular among the patients. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability in the different patient groups. The objective of this study was to evaluate the accuracy of the Omron 637IT (Omron Healthcare Europe B.V, Hoofddorp, Netherlands) wrist blood pressure device against the mercury sphygmomanometer in the elderly according to the International Protocol criteria. Seventy-six patients older than 65 years of age were studied and classified on the basis of the range of the International Protocol. Blood pressure measurements at the wrist with the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with arm circumference distributed randomly were selected for the validation study. During the validation study, 99 measurements were obtained for comparison in the 33 participants. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the sphygmomanometer device were -0.3+/-6.5 mmHg for systolic blood pressure and 2.8+/-4.8 mmHg for diastolic blood pressure in the study group. The device passed phase 1 in 15 participants. In phase 2.1, from the total 99 comparisons, 66, 87, and 95 for systolic blood pressure and 69, 92, and 97 for diastolic blood pressure were <5, <10, and <15 mmHg, respectively. In phase 2.2, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg for systolic blood pressure. For diastolic blood pressure, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg. The Omron 637 IT passed the phase 2.1 and 2.2 in the elderly group. The Omron 637IT wrist blood pressure device passed according to the International Protocol criteria and can be recommended for use in the elderly.

Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults

Wrist blood pressure devices are becoming popular for the self-measurement of blood pressure. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability. In this study, we assessed the accuracy of the Omron 637IT wrist blood pressure device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. A hundred and thirty-one participants were studied and classified on the basis of the International Protocol range. Blood pressure measurements at the wrist using the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. Initially, 33 participants with random arm circumferences were selected for the first validation study. Then, the device was evaluated in adults with arm circumferences equal to or higher than 34 cm. During each validation study, 99 measurements were obtained for comparison from the 33 participants. The first phase was performed on 15 participants, and, if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the sphygmomanometer device were 0.5+/-6.2 mmHg for systolic blood pressure and 0.1+/-3.7 mmHg for diastolic blood pressure in the adult group. The device passed phases 1 and 2 in 33 participants. Mean discrepancies and standard deviations of the sphygmomanometer device were 1.8+/-6.6 mmHg for systolic blood pressure and 1.6+/-4.7 mmHg for diastolic blood pressure in the obese adult group. The device passed phases 1 and 2 in 33 participants in this group. The Omron 637IT passed according to the International Protocol criteria and can be recommended for use in adults and obese adults.

The Accoson Greenlight 300, the first non-automated mercury-free blood pressure measurement device to pass the International Protocol for blood pressure measuring devices in adults.

Accurate blood pressure measurement is critical to successful care of the hypertensive patient. The mercury manometer is rapidly being removed from clinical practice due to concerns about environmental contamination. The Accoson Greenlight 300 device is the first non-automated mercury-free device for auscultatory blood pressure measurement to pass the International Protocol for validation of blood pressure measuring devices in adults. Fifty-one patients were enrolled to obtain the 33 patients required to fill the three systolic blood pressure (SBP) ranges (low 90-129 mmHg, medium 130-160 mmHg, high 161-180 mmHg) and diastolic blood pressure (DBP) ranges (low 40-79 mmHg, medium 80-100 mmHg, high 101-130 mmHg). Nine sequential blood pressure measurements by two observers with the mercury manometer and the supervisor with the Greenlight 300 were taken. The first two observer blood pressures were used to classify the SBP and DBP range. The readings were then analyzed in two phases to determine whether the device passed the International Protocol. The device passed Phase 1 using 15 subjects. In Phase 2.1 (n=33) for the 99 readings of SBP, 84 of 99 were within 5 mmHg, 95 of 99 were within 10 mmHg, and 98 of 99 were within 15 mmHg. For the 99 readings of DBP, 74 of 99 were within 5 mmHg, 90 of 99 were within 10 mmHg, and 96 of 99 were within 15 mmHg. In Phase 2.2 (n=33) for SBP, 33 of 33 had 2 of 3 SBP within 5 mmHg and none had all three readings >or=5 mmHg. For DBP, 27 of 33 had 2 of 3 of their DBP within 5 mmHg and only three had all three readings > or =5 mmHg. The Accoson Greenlight 300 is the first electronic non-automated blood pressure measurement device to pass the International Protocol.

A validation of the Mobil O Graph (version 12) ambulatory blood pressure monitor.

To assess the clinical accuracy of the Mobil O Graph (version 12) ambulatory blood pressure monitor in an adult population. The accuracy of the device was assessed by predefined criteria (British Hypertension Society, BHS) in 85 subjects recruited from the patients and staff in a teaching hospital. A series of same-arm sequential blood pressure measurements were taken: first two observers taking simultaneous mercury readings, followed by a reading with the Mobil O Graph ambulatory monitor. A total of seven readings were taken from each subject in the sitting position. The data were then analysed according to the BHS protocol and the criteria of the Association for the Advancement of Medical Instrumentation (AAMI). The Mobil O Graph ambulatory monitor fulfilled the criteria of the BHS protocol, achieving a grade B for systolic blood pressure (SBP) and a grade A for diastolic blood pressure (DBP). The mean differences were -2+/-8 mmHg for SBP and -2+/-7 mmHg for DBP. The device therefore also passed the AAMI standard (the mean to be within 5+/-8 mmHg). The Mobil O Graph ambulatory monitor performed in a satisfactory manner according to the BHS and the AAMI criteria and can therefore be recommended for clinical use in the general population.

Use of a neonatal blood pressure cuff to monitor blood pressure in the adult finger--comparison with a standard adult arm cuff.

There are few suitable methods for monitoring blood pressure continuously (or intermittently) for research in adult stroke patients, who are ill but do not justify invasive intensive care monitoring. We tested a neonatal arm blood pressure in adults by placing it on the forefinger ("finger cuff"). We compared the repeatability of the finger cuff with blood pressure measured by a standard adult arm cuff using the oscillometric technique in 168 ambulatory outpatients attending a cerebrovascular disease clinic. The mean difference between sequential mean blood pressure readings with the finger cuff was 0.55 mm Hg (95% confidence interval (CI) -14.36 to 15.47 mm Hg), and for the arm cuff was 3.31 mm Hg (95% CI -23.33 to 16.71 mm Hg). Measurements made with the arm cuff were shown to affect subsequent arm cuff readings made within a few minutes of the first. The mean difference between the finger cuff and arm cuff mean blood pressure readings was 0.03 mm Hg (95% CI -26.07 to 26.14 mm Hg) and agreement was better when the blood pressure was measured with the finger cuff first rather than the arm cuff. However, although there was no difference in the mean blood pressure recordings both systolic and diastolic blood pressure measurements differed systematically between arm and finger cuff. The reproducibility of sequential blood pressure measurements made with the finger cuff was better than with the arm cuff. The performance of the finger cuff compared with that of the arm cuff was sufficiently good to encourage use of the finger cuff in research involving automatic intermittent monitoring to observe sequential blood pressures over time in stroke patients. However, measurements of systolic and diastolic pressure were not the same with the two cuffs and further work on calibration of the finger cuff would be useful.