Blood Pressure Monitoring最新文献

The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects ( n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for general population.

The aim of this study was to evaluate the accuracy of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The test monitor was used to measure SBP and DBP and pulse rate in the wrists using the oscillometric method. According to this protocol using the same-arm sequential blood pressure measurement method, subjects were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the Universal Standard. A single cuff for wrist sizes of 13.5-21.5 cm was used. A total of 85 subjects were included in this study. According to Criterion 1, the mean difference in SBP between the test device and the reference device was 0.89 mmHg, with a SD of 7.76 mmHg. The mean difference of DBP was -1.44 mmHg, with a SD of 6.23 mmHg. The mean difference between SBP and DBP was less than 5.0 mmHg, and the SD was less than 8.0 mmHg, which met the requirements. According to Criterion 2, the SD of the mean differences of SBP between the test device and the reference device per subject was 5.65 mmHg, which was less than 6.88 mmHg and met the requirements. The SD of the mean differences of DBP between the test device and the reference device per subject was 5.61 mmHg, which was less than 6.78 mmHg and met the requirements. The DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor met the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). It can be recommended for home and clinical use.

Objective: The aim of this study was to evaluate the accuracy of the CONTEC08A oscillometric upper-arm blood pressure (BP) monitor for BP measurement in adults according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd)1:2020 standard.

Methods: Eighty-five subjects (male 40 and female 45) were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the ISO standard in the general population, and had a mean age of 40.2 years. The same arm sequential BP measurement method was used with three differently sized cuffs for the arm circumference ranging from 18 to 26 cm (small), 22-32 cm (medium), and 22-43 cm (large), respectively, for the test device, and two differently sized cuffs for the arm circumference ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer.

Results: Two hundred and fifty-five comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference SBP/DBP readings was 1.1 ± 6.7/3.0 ± 5.3 mmHg. For validation criterion 2, the SD of the averaged SBP/DBP differences between the test device and reference BP per subject was 5.63/4.68 mmHg.

Conclusion: The automated upper-arm BP monitor CONTEC08A has passed the requirements of the ISO Universal Standard in the general population, and can be recommended for BP measurement in adults.

Objective: The study aimed to validate the Pangao PG-800B18 oscillometric upper-arm blood pressure monitor in the general population in accordance with the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 protocol.

Methods: Participants were recruited, and the same left-arm sequential method was used for blood pressure measurement in accordance with the protocol. Data validation and analysis were performed according to the protocol, and the Bland-Altman scatter plot was used to show the difference between the test device and reference results.

Results: A total of 86 participants were included in the validation analysis. For the validation criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference readings was -1.21 ± 6.71 mmHg and -0.73 ± 5.83 mmHg for systolic (SBP) and diastolic blood pressure (DBP), respectively. Furthermore, the SD of the differences between the test device and reference readings per participant was 5.81 and 5.02 mmHg for SBP and DBP, fulfilling the criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP.

Conclusion: The Pangao PG-800B18 upper-arm blood pressure monitor fulfilled the requirements of the ISO validation standard and can be recommended for clinical use and self-measurement in the general population.

This study evaluates the measurement accuracy of the Hanvon FY730 upper-arm blood pressure (BP) monitor, which uses the Korotkoff sound method, in compliance with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018). A clinical trial involving 86 eligible adults was conducted, and data were analyzed based on standardized protocols. The mean differences between the device and reference measurements for systolic blood pressure (SBP) and diastolic blood pressure (DBP) were -0.37 mmHg (SD: 2.25 mmHg) and -0.17 mmHg (SD: 2.02 mmHg), respectively. Standard deviations for SBP (≤6.93 mmHg) and DBP (≤6.95 mmHg) met the required thresholds. A total of 258 effective paired measurements demonstrated that the Hanvon FY730 provides highly consistent results compared with reference methods, with all deviations falling within acceptable limits. The study also confirmed the device's reliability across a wide range of arm circumferences (22-36 cm) and BP levels (SBP: 90-188 mmHg, DBP: 53-107 mmHg). These findings confirm that the Hanvon FY730 complies with ISO 81060-2:2018 standards, demonstrating its suitability for accurate BP monitoring in clinical, personal, and home settings.

The aim of this study was to validate the performance of the A&D UA-1100NFC hoseless devices of two cuff sizes in monitoring blood pressure (BP) in the upper arm according to the International Organization for Standardization (ISO) 81060-2:2018/amendment (Amd) 1:2020 protocol. The accuracy of the UA-1100NFC (for arm circumferences of 22.0-32.0 cm) and the UA-1100NFC-W (for arm circumferences of 22.0-42.0 cm) was assessed using the same-arm sequence protocol as per the ISO 81060-2:2018/Amd 1:2020 standard. Individuals aged >12 years were recruited from the outpatients and volunteers of Jichi Medical University (Tochigi, Japan); 85 participants were included in the final analyses for each device. Both devices performed well against the standard; mean and SD values for the differences between the device-measured and observer-measured SBP and DBP values met both criterion 1 and criterion 2 of the standard [(UA-1100NFC) criterion 1: -3.71 ± 6.82 mmHg and 0.86 ± 6.33 mmHg, respectively; criterion 2: 5.65 mmHg and 5.87 mmHg, respectively; (UA-1100NFC-W) criterion 1: 0.73 ± 7.84 mmHg and 1.72 ± 6.44 mmHg, respectively; criterion 2: 6.49 mmHg and 5.86 mmHg, respectively]. The Bland-Altman plots did not show any systematic variation in the error. Both the UA-1100NFC and UA-1100NFC-W hoseless devices had a high level of accuracy and fulfilled the requirements of the ISO81060-2:2018/Amd 1:2020 validation standard. They are therefore suitable as home BP monitoring tools in patients with hypertension.

Aim: ST2 receptor is a member of toll-like/interleukin-1 receptor family. After the activation of IL-33/ST2 signaling pathway clinically detectable amount of soluble form of ST2 (sST2) is released into the circulation. Previous studies showed that sST2 levels were significantly higher in hypertension patients than in controls. In this prospective study, we aimed to analyze this relation and test the predictive accuracy of the sST2 level in diagnosis of nondipping hypertension in newly diagnosed hypertension patients.

Methods: Three hundred thirty-seven patients (150 normal, 187 hypertension) who presented with symptoms of hypertension were included in the study. All patients underwent 24-h ambulatory blood pressure monitoring and sST2 measurement.

Results: Of 187 hypertension patients, 92 of them had nondipping and 95 of them had dipping pattern. sST2 level was significantly higher in nondipping group compared to dipping group and control group (40.79 ± 7.77 vs. 32.47 ± 6.68; P  < 0.0001 and 40.79 ± 7.77 vs. 20.09 ± 7.09; P  < 0.0001 respectively). Binary logistic regression analysis revealed that; only sST2 level was an independent risk factor for hypertension [ P  < 0.0001, β : 1.258, odds ratio (OR) (95% confidence interval (CI)): 1.158-1.366]. and also nondipping hypertension [ P  < 0.0001, β : 1.208, OR (95% CI): 1.108-1.317].

Conclusion: Based on the present study it could be concluded that sST2 level is significantly associated with the newly diagnosed hypertension and nondipping hypertension. Hence it could reliably be used to diagnose hypertension and nondipping hypertension with high sensitivity and specificity.

Background: Morning blood pressure surge (MBPS) has been recognized as an independent predictor of cardiovascular disease events. Psychological distress, including anxiety, depression, and perceived stress, and behavioral risk factors, such as poor sleep quality, have been associated with increased MBPS. Elevations in sympathetic activity induced by forced awakening may also contribute to further increases in MBPS. Yet, no examination of the interrelationships among psychological distress, sleep quality, awakening mode (natural vs. forced awakenings), and MBPS has been undertaken.

Objective: This pilot study aimed: (1) to examine if MBPS differs by awakening mode and (2) to investigate whether psychological distress is associated with MBPS difference between natural and forced awakenings, independent of sleep quality.

Methods: Thirty-two healthy adults were included in this cross-sectional study. Blood pressure was measured using a beat-to-beat blood pressure monitor over two nights, consisting of one night of natural awakening and one night of forced awakening. Psychological distress and sleep quality were assessed using questionnaires. We conducted paired t -tests (aim 1) and multiple linear regressions (aim 2).

Results: MBPS was significantly greater during forced awakening compared with natural awakening. In addition, the MBPS difference between natural and forced awakenings was significantly greater in participants with higher anxiety levels, independent of sleep quality.

Conclusion: We found that augmentation of MBPS by forced awakening was significantly greater in individuals who reported higher anxiety levels. Additional research is needed to examine the potential impacts of forced awakening and anxiety on MBPS in a larger sample of individuals at risk for cardiovascular disease.

Objective: A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm.

Methods: Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018.

Results: According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements.

Conclusion: Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.

Objective: Remote patient monitoring (RPM) beat-to-beat blood pressure (BP) provides an opportunity to measure poststroke BP variability (BPV), which is associated with clinical stroke outcomes. BP sampling interval (SI) influences ambulatory BPV, but RPM BP SI optimisation research is limited. SI and RPM device capabilities require compromises, meaning SI impact requires investigation. Therefore, this study assessed healthy and stroke subtype BPV via optimised BP sampling, aiding sudden BP change identification and potentially assisting cardiovascular event (recurrent stroke) prediction.

Methods: Leicester Cerebral Haemodynamic Database ischaemic [acute ischaemic stroke (AIS), n  = 68] and haemorrhagic stroke (intracerebral haemorrhage, n  = 12) patient and healthy control (HC, n  = 40) baseline BP data were analysed. Intrasubject and interpatient SD (SD i /SD p ) represented individual/population variability with synthetically altered SIs. Matched-filter approaches using cross-correlation function detected sudden BP changes.

Results: At SIs between 1 and 180 s, SBP and DBP SD i staticised while SD p increased at SI < 30 s. Mean BP and HR SD i and SD p increased at SI < 60s. AIS BPV, normalised to SI1s, increased at SI30s (26%-131%) and SI120s (1%-274%). BPV increased concomitantly with SI. Cross-correlation analysis showed HC and AIS BP sudden change detection accuracy reductions with increasing SI. Positive BP deviation detection fell 48.48% (SI10s) to 78.79% (SI75s) in HC and 67.5% (SI10s) to 100% (SI75s) in AIS. Negative BP deviation detection fell 50% (SI10s) to 82.35% (SI75s) in HC and 52.27% (SI10s) to 95.45% (SI75s) in AIS.

Conclusion: Sudden BP change detection and BPV are relatively robust to SI increases within certain limits, but accuracy reductions generate unacceptable estimates, considerable within RPM device design. This research warrants further SI optimisation.