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Validation of the Mindray VS9 Vital Signs Monitor in a combined adult and pediatric population according to ISO Standard 81060-2:2018. 根据 ISO 标准 81060-2:2018,在成人和儿童人群中对 Mindray VS9 生命体征监护仪进行验证。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-08-01 Epub Date: 2024-03-25 DOI: 10.1097/MBP.0000000000000704
Na Guo, Yihan Zhang, Weiqiang Chen, Hexian Zhong, Liping Li, Hanbin Xie, Wenxiu Zhu, Jun Liu, Shangrong Li

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 ± 6.6/-1.8 ± 7.1 mmHg (systolic/diastolic) when the deflation algorithm was used, and 2.4 ± 6.3/ 0.3 ± 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.

Mindray VS9 生命体征监护仪采用 Mindray TrueBP 充气算法进行示波血压测量,我们的目的是在成人和儿童人群中验证该仪器的准确性,以检查其是否符合国际标准化组织标准 (ISO 81060-2:2018)。该研究共招募了 86 名参与者,包括成人和儿童受试者。他们的年龄、性别、血压和肢体尺寸分布均符合 ISO 标准的要求。采用同臂顺序血压测量法对充气和放气算法进行了独立验证。首先,由两名独立观察员使用水银血压计(R1)测量每位受试者的血压。然后由第三位观察员使用测试设备测定受试者的血压(T1)。然后,两名独立观察员使用水银血压计再次测定受试者的血压(R2)。R1-T1-R2 被视为一对有效数据。如此循环,直至获得 3 对有效数据。我们收集了 258 对有效血压数据,分别用于验证充气和放气算法。对于验证标准 1,使用放气算法时,从测试设备获得的读数与参考血压之间差异的平均值(± SD)为 0.0 ± 6.6/-1.8 ± 7.1 mmHg(收缩压/舒张压);使用充气算法时,差异的平均值(± SD)为 2.4 ± 6.3/ 0.3 ± 6.9 mmHg(收缩压/舒张压)。对于验证标准 2,当使用放气算法时,每个受试者的测试设备与参考血压之间的平均血压差值的 SD 为 5.35/6.33 mmHg(收缩压/舒张压);当使用充气算法时,每个受试者的测试设备与参考血压之间的平均血压差值的 SD 为 5.17/5.75 mmHg(收缩压/舒张压)。VS9 生命体征监护仪符合 ISO 标准中的所有标准。此外,充气算法的测量时间更短(7-21 秒),最大充气压力更低(9.7-22 毫米汞柱)。VS9 生命体征监护仪在成人和儿童人群中均符合 ISO 标准(ISO 81060-2:2018)的所有要求,建议临床使用。
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引用次数: 0
Home blood pressure measurement days and changes in urinary sodium-to-potassium ratio, estimated salt and potassium intakes and blood pressure: 1-year prospective study. 家庭血压测量天数与尿钠钾比率、盐和钾的估计摄入量以及血压的变化:为期一年的前瞻性研究。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-08-01 Epub Date: 2024-06-26 DOI: 10.1097/MBP.0000000000000705
Minako Kinuta, Takashi Hisamatsu, Mari Fukuda, Kaori Taniguchi, Noriko Nakahata, Hideyuki Kanda

Objective: Current international guidelines recommend home blood pressure (BP) measurement and low sodium and high potassium intakes for the management of hypertension. We hypothesized that increased home BP measurement may result in more effective management of sodium and potassium intakes and BP.

Methods: We examined associations of home BP measurement days with changes in the urinary sodium-to-potassium (Na/K) ratio, estimated salt and potassium intakes and BP. We included 209 healthy participants (mean age, 55.9 years; 56.5% women) from a prospective cohort study. We examined 1-year data on self-measured home BP and spot urine samples.

Results: Median (interquartile range) days of home BP measurement was 324 (225-358) over 1-year. Baseline mean (SD) Na/K ratio, salt and potassium intakes, morning and evening SBP, and morning and evening DBP were 3.8 (2.3), 8.5 (1.9) g/day, 1833.5 (416.5) mg/day, 120.4 (14.0) mmHg, 118.2 (14.2) mmHg, 79.2 (10.1) mmHg, and 76.2 (10.1) mmHg, respectively. In multivariable-adjusted linear regression , β (standard error) per 10 days increase in number of home BP measurement were -0.031 (0.017) for Na/K ratio, -0.036 (0.015) for salt intake, -1.357 (2.797) for potassium intake, -0.178 (0.064) for morning SBP, -0.079 (0.041) for morning DBP, -0.109 (0.067) for evening SBP and -0.099 (0.045) for evening DBP. Additionally, relationships persisted for men and women, but changes in salt intake were more pronounced among participants taking antihypertensive medication (interaction P = 0.002).

Conclusion: Continuous measurement of home BP may lead not only to self-monitoring of BP, but also to declines in salt intakes and some BP indices.

目的:目前的国际指南建议在家中测量血压并摄入低钠和高钾以控制高血压。我们假设,增加居家血压测量可更有效地控制钠和钾的摄入量以及血压:我们研究了家庭血压测量天数与尿钠钾(Na/K)比值变化、盐和钾的估计摄入量以及血压之间的关系。我们纳入了一项前瞻性队列研究中的 209 名健康参与者(平均年龄 55.9 岁;56.5% 为女性)。我们检查了自测家庭血压和定点尿样的 1 年数据:结果:1 年中家庭血压测量天数的中位数(四分位数间距)为 324 天(225-358 天)。Na/K 比值、盐和钾摄入量、早晚 SBP 和早晚 DBP 的基线平均值(标度)分别为 3.8 (2.3)、8.5 (1.9)克/天、1833.5 (416.5) 毫克/天、120.4 (14.0) 毫米汞柱、118.2 (14.2) 毫米汞柱、79.2 (10.1) 毫米汞柱和 76.2 (10.1) 毫米汞柱。在多变量调整线性回归中,Na/K 比值每增加 10 天,家庭血压测量次数的 β(标准误差)为-0.031(0.017),盐摄入量为-0.036(0.015),钾摄入量为-1.357(2.797),晨间 SBP 为-0.178(0.064),晨间 DBP 为-0.079(0.041),晚间 SBP 为-0.109(0.067),晚间 DBP 为-0.099(0.045)。此外,男性和女性之间的关系持续存在,但盐摄入量的变化在服用降压药的参与者中更为明显(交互作用 P = 0.002):结论:连续测量家庭血压不仅可以自我监测血压,还可以减少盐摄入量和某些血压指数。
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引用次数: 0
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). 根据 AAMI/ESH/ISO 通用标准在普通人群中验证新型专业自动听诊式上臂袖带血压计:KOROT V2 Doctor (InBody BPBIO280KV)。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-08-01 Epub Date: 2024-05-17 DOI: 10.1097/MBP.0000000000000707
Aikaterini Theodosiadi, Vasileios Ntousopoulos, Angeliki Ntineri, Panagiota Stathopoulou, Ariadni Menti, Konstantinos G Kyriakoulis, Anastasios Kollias, George S Stergiou

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 ± 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 ± 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.

目的:为专业人员开发了一种新型自动听诊式上臂袖带血压(BP)监测仪 KOROT V2 Doctor(InBody BPBIO280KV)。设备袖带中嵌入的电子听诊器可记录 Korotkoff 音,放气时以图形显示,以便医护人员进行可视化评估。该设备可自动测量血压,本研究对其准确性进行了评估:研究采用了医疗仪器促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准(ISO 81060-2:2018)及其 1.2020-01 修正案的要求。采用相同的手臂顺序测量方法,在普通人群中招募符合通用标准及其修订版规定的年龄、性别、血压、臂围和袖带分布标准的参与者。测试设备的三个袖带分别测试了臂围 23-28、28-35 和 33-42 厘米:分析了 85 人的数据[平均年龄:56.4 ± 16.0 (SD) 岁,男性 50 人,臂围 23-42 厘米]。对于验证标准 1,测试设备和参考血压读数(N = 255)之间的平均差(±SD)为-1.3 ± 6.0/1.5 ± 5.0 mmHg(收缩压/舒张压;阈值≤5 ± 8 mmHg)。对于标准 2,每个人(N = 85)的平均血压差异的 SD 为 4.61/3.48 mmHg(收缩压/舒张压;阈值≤6.82/6.78 mmHg):KOROT V2 Doctor(InBody BPBIO280KV)专业设备可提供自动听诊测量,并可视化显示 Korotkoff 音,在普通人群中可轻松满足 AAMI/ESH/ISO 通用标准(ISO 81060-2:2018)的所有要求,建议临床使用。
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引用次数: 0
A comparison among oscillometric waveforms in healthy nonpregnant women, pregnancy and hypertensive disorders of pregnancy. 健康非孕妇、孕妇和妊娠高血压患者的示波波形比较。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-08-01 Epub Date: 2024-03-05 DOI: 10.1097/MBP.0000000000000700
Jennifer S Ringrose, Sangita Sridar, Patricia Araneta, Lillian Chan, Jalisa Kassam, Mira Wirzba, Kate Greeff, Gillian Ramsay, Winnie Sia, Rshmi Khurana, Erin Bader, Raj Padwal

Objective: Understanding of how oscillometric waveforms (OMW) vary between pregnant and nonpregnant individuals remains low. An exploratory analysis was completed to assess for quantitative and qualitative changes in OMW and oscillometric envelope features in pregnancy.

Design and methods: Eighteen pregnant individuals (over 20 weeks gestational age) and healthy, nonpregnant (HNP) women were recruited. Six HNP were matched to six healthy pregnant (HP) women, and six pregnant women with a hypertensive disorder of pregnancy (HDP) by age, arm circumference, and cuff size. Blood pressure measurements were completed per the International Organization for Standardization (ISO) protocol using a custom-built oscillometric device as the test device and two-observer mercury auscultation as the reference measurement. Auscultatory blood pressure and blood pressure derived from slope-based and fixed ratio algorithms were determined. OMW and envelope features were compared among groups.

Results: In HNP, HP, and HDP groups respectively: mean auscultatory blood pressure (systolic mean ± SD/diastolic mean ± SD) was 103.4 ± 12.2/67.1 ± 7.9; 109.5 ± 3.1/58.1 ± 6.4; 135.6 ± 18.9/85.1 ± 14.2 mmHg. HDP had significantly higher auscultatory systolic and diastolic blood pressure than the HP group ( P  = 0.001). The pregnant groups had a lower average pulse width (mean ± SD: HNP = 0.8 ± 0 s, HP = 0.6 ± 0.1 s, HDP = 0.6 ± 0.1 s; HP vs. HNP mean difference [adjusted P value]: 0.2 [ P  = 0.004], HDP vs. HNP 0.1 [ P  = 0.018]) compared with the HNP group. The HDP group had a larger area under the OMW envelope than the HNP group (mean ± SD: HNP = 22.6 ± 3.4; HDP = 28.5 ± 4.2; HDP vs. HNP mean difference [adjusted P value]: 5.9 P  = 0.05).

Conclusion: In this exploratory work, differences in the OMW morphology and parameters were found in pregnancy and in hypertensive disorders of pregnancy compared with healthy controls. Even small differences may have important implications in algorithm development; further work comparing OMW envelopes in pregnancy is needed to optimize the algorithms used to determine blood pressure in pregnancy.

目的:人们对妊娠期和非妊娠期个体的振荡波形(OMW)如何变化的了解仍然较少。我们完成了一项探索性分析,以评估妊娠期 OMW 和示波包络特征的定量和定性变化:招募了 18 名孕妇(孕龄超过 20 周)和健康非孕妇(HNP)。根据年龄、臂围和袖带尺寸,将 6 名妊娠高血压患者与 6 名健康孕妇(HP)和 6 名妊娠高血压疾病孕妇(HDP)进行配对。血压测量按照国际标准化组织 (ISO) 的规程进行,使用定制的示波测量仪作为测试设备,使用双观察者水银听诊法作为参考测量方法。测定了听诊血压以及基于斜率算法和固定比率算法得出的血压。比较了各组的 OMW 和包膜特征:HNP、HP 和 HDP 组的平均听诊血压(收缩压平均值 ± SD/舒张压平均值 ± SD)分别为 103.4 ± 12.2/67.1 ± 7.9;109.5 ± 3.1/58.1 ± 6.4;135.6 ± 18.9/85.1 ± 14.2 mmHg。HDP 组的听诊收缩压和舒张压明显高于 HP 组(P = 0.001)。孕妇组的平均脉搏宽度较低(平均值±标准差:HNP = 0.8 ± 0 秒,HP = 0.6 ± 0.1 秒,HDP = 0.6 ± 0.1 秒;HP 与 HNP 的平均值差异[调整后 P 值]为 0.2 [P = 0.001]:0.2 [P = 0.004],HDP vs. HNP 0.1 [P = 0.018])。与 HNP 组相比,HDP 组的 OMW 包膜下面积更大(平均值 ± SD:HNP = 22.6 ± 3.4;HDP = 28.5 ± 4.2;HDP 与 HNP 的平均差异 [调整后 P 值]:5.9 [P = 0.05]):5.9 P = 0.05):在这项探索性研究中发现,与健康对照组相比,妊娠期和妊娠期高血压疾病患者的 OMW 形态和参数存在差异。即使是微小的差异也可能对算法的开发产生重要影响;需要进一步比较妊娠期的 OMW 包络线,以优化用于测定妊娠期血压的算法。
{"title":"A comparison among oscillometric waveforms in healthy nonpregnant women, pregnancy and hypertensive disorders of pregnancy.","authors":"Jennifer S Ringrose, Sangita Sridar, Patricia Araneta, Lillian Chan, Jalisa Kassam, Mira Wirzba, Kate Greeff, Gillian Ramsay, Winnie Sia, Rshmi Khurana, Erin Bader, Raj Padwal","doi":"10.1097/MBP.0000000000000700","DOIUrl":"10.1097/MBP.0000000000000700","url":null,"abstract":"<p><strong>Objective: </strong>Understanding of how oscillometric waveforms (OMW) vary between pregnant and nonpregnant individuals remains low. An exploratory analysis was completed to assess for quantitative and qualitative changes in OMW and oscillometric envelope features in pregnancy.</p><p><strong>Design and methods: </strong>Eighteen pregnant individuals (over 20 weeks gestational age) and healthy, nonpregnant (HNP) women were recruited. Six HNP were matched to six healthy pregnant (HP) women, and six pregnant women with a hypertensive disorder of pregnancy (HDP) by age, arm circumference, and cuff size. Blood pressure measurements were completed per the International Organization for Standardization (ISO) protocol using a custom-built oscillometric device as the test device and two-observer mercury auscultation as the reference measurement. Auscultatory blood pressure and blood pressure derived from slope-based and fixed ratio algorithms were determined. OMW and envelope features were compared among groups.</p><p><strong>Results: </strong>In HNP, HP, and HDP groups respectively: mean auscultatory blood pressure (systolic mean ± SD/diastolic mean ± SD) was 103.4 ± 12.2/67.1 ± 7.9; 109.5 ± 3.1/58.1 ± 6.4; 135.6 ± 18.9/85.1 ± 14.2 mmHg. HDP had significantly higher auscultatory systolic and diastolic blood pressure than the HP group ( P  = 0.001). The pregnant groups had a lower average pulse width (mean ± SD: HNP = 0.8 ± 0 s, HP = 0.6 ± 0.1 s, HDP = 0.6 ± 0.1 s; HP vs. HNP mean difference [adjusted P value]: 0.2 [ P  = 0.004], HDP vs. HNP 0.1 [ P  = 0.018]) compared with the HNP group. The HDP group had a larger area under the OMW envelope than the HNP group (mean ± SD: HNP = 22.6 ± 3.4; HDP = 28.5 ± 4.2; HDP vs. HNP mean difference [adjusted P value]: 5.9 P  = 0.05).</p><p><strong>Conclusion: </strong>In this exploratory work, differences in the OMW morphology and parameters were found in pregnancy and in hypertensive disorders of pregnancy compared with healthy controls. Even small differences may have important implications in algorithm development; further work comparing OMW envelopes in pregnancy is needed to optimize the algorithms used to determine blood pressure in pregnancy.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"167-172"},"PeriodicalIF":1.2,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140093424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validation of the Meditech ABPM-06 24-hour blood pressure monitoring system in a pediatric population according to International Organization for Standardization Protocol 81060-2:2018. 根据国际标准化组织 81060-2:2018 协议,验证 Meditech ABPM-06 24 小时血压监测系统在儿科人群中的应用。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-08-01 Epub Date: 2024-03-11 DOI: 10.1097/MBP.0000000000000701
Andrea E Jakab, Edit Horváth, Dorottya Molnár, Mátyás Bukva, Csaba Bereczki

Objective: Ambulatory blood pressure monitoring (ABPM) devices play a crucial role in diagnosing hypertension, not only in adults but also in pediatric patients. ABPM-06, the latest oscillometric device from Meditech Ltd. (Budapest, Hungary), is the focus of this study. The objective was to validate the ABPM-06 device using the International Organization for Standardization (ISO) 81060-2 : 2018 standard.

Methods: A total of 86 healthy patients, consisting of 34 males and 52 females, aged between 3 and 17 years, were enrolled in this study. During the ambulatory phase, a total of 50 patients were enrolled, with 35 patients falling within the 3- to 12-year-old age range and 15 patients aged between 12 and 17 years. Additionally, for the dynamic test, 36 patients were selected, comprising of 10 individuals aged 3-12 years and 26 patients aged 12-17 years. These patients were recruited from the outpatient clinics of the Department of Pediatrics at Albert Szent-Györgyi University in Szeged, Hungary. The validation process involved utilizing the same-arm sequence protocol, both in resting positions and during stress testing.

Results: The ABPM-06 performed well in both clinical and ambulatory validations. In terms of validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -1.3 ± 3.5  mmHg for systolic and -0.1  ± 2.3 mmHg for diastolic, in children under the age of 12 years. For those over the age of 12 years, the mean ± SD of the differences was -2.8 ± 4.6 mmHg for systolic and -0.5 ± 2.7 mmHg for diastolic. Regarding the ambulatory validation, for children under 12 years old, the mean ± SD of the differences was -1.3  ± 3.5  mmHg for systolic and -0.1  ± 2.3  mmHg for diastolic. In the age group above 12 years, the mean ± SD of the differences was -2.8 ± 4.6 mmHg for systolic and -0.5 ± 2.7 mmHg for diastolic. Both tests successfully met the established criteria regarding the mean and SD values of the differences between the device readings and the observed SBP and DBP measurements.

Conclusion: The ABPM-06 oscillometric device fully adheres to the ISO 81060-2 : 2018 standard requirements for ABPM determination in the pediatric population (ages 3-17 years). Consequently, this ABPM device proves to be suitable for effectively managing hypertension in children and adolescents.

目的:非卧床血压监测(ABPM)设备在诊断高血压方面发挥着至关重要的作用,不仅适用于成人,也适用于儿童患者。ABPM-06 是 Meditech Ltd. 公司(匈牙利布达佩斯)最新推出的示波测量设备。(匈牙利布达佩斯)的最新示波测量设备 ABPM-06 是本研究的重点。目的是采用国际标准化组织 (ISO) 81060-2 : 2018 标准验证 ABPM-06 设备:本研究共招募了 86 名健康患者,其中男性 34 名,女性 52 名,年龄在 3 至 17 岁之间。在非卧床阶段,共招募了 50 名患者,其中 35 名患者的年龄在 3 至 12 岁之间,15 名患者的年龄在 12 至 17 岁之间。此外,还选择了 36 名患者进行动态测试,其中 10 人年龄在 3-12 岁之间,26 人年龄在 12-17 岁之间。这些患者是从匈牙利塞格德阿尔伯特-森特-琼吉大学儿科系门诊部招募的。验证过程包括在静息体位和压力测试期间使用同臂序列协议:ABPM-06 在临床和非卧床验证中均表现良好。就验证标准 1 而言,在 12 岁以下儿童中,测试设备与参考血压读数之间的差异平均值(± SD)为收缩压-1.3 ± 3.5 mmHg,舒张压-0.1 ± 2.3 mmHg。而 12 岁以上儿童的收缩压和舒张压差异的平均值(± SD)分别为-2.8±4.6 毫米汞柱和-0.5±2.7 毫米汞柱。在非卧床验证方面,12 岁以下儿童收缩压差异的平均值(± SD)为-1.3 ± 3.5 mmHg,舒张压差异的平均值(± SD)为-0.1 ± 2.3 mmHg。在 12 岁以上年龄组中,收缩压差异的平均值(± SD)为-2.8 ± 4.6 mmHg,舒张压差异的平均值(± SD)为-0.5 ± 2.7 mmHg。这两项测试都成功地达到了关于设备读数与观察到的收缩压和舒张压测量值之间差异的平均值和 SD 值的既定标准:ABPM-06 血压计完全符合 ISO 81060-2 : 2018 标准对儿童(3-17 岁)进行 ABPM 测定的要求。因此,该 ABPM 设备证明适用于有效管理儿童和青少年的高血压。
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引用次数: 0
Validation of the JAMR upper-arm pressure monitor B23 according to the AAMI/ESH/ISO Universal Standard (ISO 81060- 2:2018/AMD 1:2020). 根据 AAMI/ESH/ISO 通用标准(ISO 81060- 2:2018/AMD 1:2020)对 JAMR 上臂压力监测仪 B23 进行验证。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-07-30 DOI: 10.1097/MBP.0000000000000719
Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan

The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.

本研究旨在根据 AAMI/ESH/ISO 通用标准(ISO 81060-2 : 2018/AMD 1 : 2020)评估 JAMR 上臂式血压计 B23 在普通人群中的准确性。该研究招募了在人数、性别、年龄、肢体大小和血压(BP)分布方面符合 AAMI/ESH/ISO 通用标准的参与者。研究使用测试设备和标准水银血压计依次测量血压,包括 SBP 和 DBP。在 90 名参与者中,对 85 名合格参与者进行了分析。共获得并分析了 255 组对比数据(每个受试者三组)。对于验证标准 1,JAMR B23 和水银血压计血压读数之间差异的平均值(± SD)为 -0.24 ± 6.52/-2.67 ± 5.6 mmHg(SBP/DBP)。对于标准 2,每名参与者的 JAMR B23 和参考血压(SBP/DBP)之间的平均血压(SBP/DBP)差异的 SD 为 5.61/5.13 mmHg(通过计算,要求≤6.95/6.43 mmHg)。JAMR B23 通过了 AAMI/ESH/ISO 通用标准(ISO 81060-2 : 2018/AMD 1 : 2020)的所有要求,可推荐用于普通人群的临床和自我/家庭使用。
{"title":"Validation of the JAMR upper-arm pressure monitor B23 according to the AAMI/ESH/ISO Universal Standard (ISO 81060- 2:2018/AMD 1:2020).","authors":"Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan","doi":"10.1097/MBP.0000000000000719","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000719","url":null,"abstract":"<p><p>The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141892806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validation of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the ISO 81060-2:2018/AMD 1:2020 protocol. 根据 ISO 81060-2:2018/AMD 1:2020 协议,在普通人群中验证 DBP-8278B 腕式全自动血压计。
IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-07-16 DOI: 10.1097/MBP.0000000000000717
Qi Zhou

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.

本研究旨在根据 AAMI/ESH/ISO 通用标准(ISO 81060-2 : 2018/AMD 1 : 2020)评估 DBP-8278B 腕式全自动血压计在普通人群中的准确性。测试监护仪采用示波法测量腕部的 SBP、DBP 和脉搏。根据该协议,使用同臂顺序血压测量方法,招募的受试者均符合通用标准的年龄、性别、血压和袖带分布标准。使用的袖带尺寸为 13.5-21.5 厘米。本研究共纳入 85 名受试者。根据标准 1,测试设备和参照设备之间的 SBP 平均差异为 0.89 mmHg,标度为 7.76 mmHg。DBP 的平均差异为-1.44 mmHg,标准差为 6.23 mmHg。SBP 和 DBP 的平均差小于 5.0 mmHg,标差小于 8.0 mmHg,符合要求。根据标准 2,每个受试者的测试设备与参照设备之间的 SBP 平均差的 SD 为 5.65 mmHg,小于 6.88 mmHg,符合要求。每个受试者的测试设备和参照设备之间的 DBP 平均差异的 SD 值为 5.61 mmHg,小于 6.78 mmHg,符合要求。DBP-8278B 腕式全自动血压计符合 AAMI/ESH/ISO 通用标准(ISO 81060-2 : 2018/AMD 1 : 2020)的要求。推荐用于家庭和临床。
{"title":"Validation of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the ISO 81060-2:2018/AMD 1:2020 protocol.","authors":"Qi Zhou","doi":"10.1097/MBP.0000000000000717","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000717","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Noninvasive pediatric blood pressure assessment: exploring the clinicians' perspective. 无创儿科血压评估:探索临床医生的视角。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-02-19 DOI: 10.1097/MBP.0000000000000693
Natalie P Stewart, Catherine Quinlan, Stephanie Best, Jonathan P Mynard

Background: Obtaining accurate and reliable blood pressure (BP) readings in pediatric patients is challenging, given difficulties in adhering to measurement guidelines, limited device validation and variable patient cooperation. This study aimed to investigate clinicians' perspectives surrounding noninvasive pediatric BP assessment to identify opportunities for improvement in BP technology and clinical practice.

Method: Based on an adapted version of the extended Technology Acceptance Model 2, semi-structured interviews were conducted with clinicians involved in noninvasive pediatric BP assessment in a major Australian children's hospital. Transcripts were analyzed thematically and guided by Technology Acceptance Model 2.

Results: Clinician responses ( n  = 20) revealed that poor patient tolerance of BP measurement resulting from excessive cuff inflation is a major hindrance to reliable pediatric BP assessment. Clinicians described low trust in BP readings from automated devices, often relating to poor patient tolerance to cuff inflation, thereby diminishing the clinical utility of these readings in informing treatment decisions. Auscultatory measurement was regarded as more trustworthy and better tolerated, but less convenient to perform as compared with oscillometric measurement.

Conclusion: A dissonance exists between (1) low trust and clinical utility of the most common and easy-to-use BP measurement approach (automated devices), versus (2) higher trust and clinical utility, but efficiency and user-related impediments, for the auscultatory method. Based on our results, we have developed the Blood Pressure Acceptance Model, which can be used to explain and predict clinicians' acceptance of BP technology. Further work is needed to improve the tolerability and accuracy of automated BP devices in real-world pediatric settings.

背景:在儿科患者中获取准确可靠的血压(BP)读数具有挑战性,因为很难遵守测量指南、设备验证有限以及患者合作程度不一。本研究旨在调查临床医生对无创儿科血压评估的看法,以确定改进血压技术和临床实践的机会:方法:根据经过改编的扩展技术接受模型 2,对澳大利亚一家大型儿童医院参与无创儿科血压评估的临床医生进行了半结构式访谈。在技术接受模式 2 的指导下,对访谈记录进行了专题分析:临床医生的回答(n = 20)显示,袖带过度充气导致患者对血压测量的耐受性差是阻碍可靠的儿科血压评估的主要原因。临床医生对自动设备的血压读数信任度较低,这往往与患者对袖带充气的耐受性差有关,从而降低了这些读数在为治疗决策提供信息方面的临床实用性。听诊法测量被认为更值得信赖,患者的耐受性更好,但与示波法测量相比,听诊法测量不太方便:结论:(1) 最常见、最易用的血压测量方法(自动设备)的信任度和临床实用性较低,而(2) 听诊法的信任度和临床实用性较高,但效率和用户相关障碍较高,这两者之间存在不一致。根据我们的研究结果,我们建立了血压接受度模型,该模型可用于解释和预测临床医生对血压技术的接受度。要提高自动血压设备在实际儿科环境中的耐受性和准确性,还需要进一步的工作。
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引用次数: 0
Lowering blood pressure by exercise: investigating the effect of sweating. 通过运动降低血压:研究出汗的影响。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-01-15 DOI: 10.1097/MBP.0000000000000691
Rastegar Hoseini, Rasha Raed Hamid

High blood pressure (hypertension), is a common medical condition, affecting millions of people and is associated with significant health risks. Exercise has been suggested to manage hypertension by inducing sweating and the corresponding loss of sodium and water from the body.Thus, a variety of epidemiological and clinical studies have been conducted to investigate the relationship between sweating and exercise-induced blood pressure reduction and its impacts on hypertension. The mechanisms underlying exercise-induced blood pressure reduction are complex and still not fully understood. However, several pathways have been suggested, including the loss of sodium and water through sweat, a decrease in peripheral resistance, and an improvement in endothelial function in the blood vessels. The decrease in sodium and water content in the body associated with sweating may result in a reduction in blood volume and thus a decrease in blood pressure. Moreover, the reduction in peripheral resistance is thought to be mediated by the activation of the nitric oxide synthase pathway and the release of vasodilators such as prostacyclin and bradykinin, which lead to vasodilation and, thus, a reduction in blood pressure. In conclusion, exercise-induced sweating and consequent sodium and water loss appear to be a reliable biological link to the blood pressure-reducing effects of exercise in hypertensive individuals. Additionally, the mechanisms underlying exercise-induced blood pressure reduction are complex and involve several biological pathways in the cardiovascular system. Therefore, understanding the role of sweat production in blood pressure management is important for developing effective exercise interventions to prevent and manage hypertension.

高血压(高血压)是一种常见的疾病,影响着数百万人,并与重大的健康风险相关。因此,人们开展了各种流行病学和临床研究,探讨出汗与运动诱导血压降低之间的关系及其对高血压的影响。运动诱导血压降低的机制十分复杂,至今仍未完全明了。不过,有几种途径已被提出,包括通过出汗流失钠和水分、降低外周阻力和改善血管内皮功能。与出汗相关的体内钠和水含量的减少可能会导致血容量的减少,从而降低血压。此外,外周阻力的降低被认为是由一氧化氮合酶途径的激活和血管扩张剂(如前列环素和缓激肽)的释放介导的,这导致血管扩张,从而降低血压。总之,运动引起的出汗和随之而来的钠和水的流失似乎是高血压患者运动降压效果的可靠生物学联系。此外,运动诱导降压的机制非常复杂,涉及心血管系统的多个生物途径。因此,了解汗液分泌在血压管理中的作用对于制定有效的运动干预措施以预防和控制高血压非常重要。
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引用次数: 0
Relationship between the behavior change model and salt intake in hypertensive patients: a single non-specialized hypertension clinic prospective observational study. 高血压患者行为改变模式与盐摄入量之间的关系:一项单一非专科高血压诊所前瞻性观察研究。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-02-02 DOI: 10.1097/MBP.0000000000000692
Hiromitsu Sekizuka, Toshiya Ishii, Hitoshi Miyake

We investigated whether changes in salt reduction readiness are associated with changes in estimated daily salt intake and blood pressure (BP). We divided 86 hypertensive patients into groups with high and low readiness for salt-reducing behavior [an up (UP) and a down (DN) groups, respectively] based on the transtheoretical model (TTM) over a 12-month observation period. We then investigated the relationships between changes in the TTM stage and changes in daily salt intake and BP over 12 months. The patients in the UP group had significantly increased urine potassium concentrations (from 51.2 ± 23.3 mEq/L at baseline to 56.9 ± 25.5 mEq/L at 12 months; P  = 0.048) and significantly decreased estimated 24-h urinary salt excretion (from 9.7 ± 2.9 g/day at baseline to 8.4 ± 2.8 g/day at 12 months; P  = 0.045). In addition, they also had significantly lower changes in urine sodium concentration (-13.1 ± 46.1 vs. -6.6 ± 59.7 mEq/L; P  = 0.048), significantly increased changes in urine potassium concentration (5.7 ± 20.1 vs. -4.8 ± 28.6 mEq/L; P  = 0.030), and significantly decreased changes in estimated 24-h urinary salt excretion (-1.3 ± 2.6 vs. -0.1 ± 2.6 g/day; P  = 0.045) compared with patients in the DN group. However, their home BP did not improve over 12 months. The hypertensive patients who increased their readiness or maintained a high readiness for salt reduction over 12 months showed a significant increase in daily potassium intake and significant decrease in daily salt intake.

我们研究了减盐意愿的变化是否与估计的每日盐摄入量和血压(BP)的变化有关。在为期 12 个月的观察期间,我们根据跨理论模型(TTM)将 86 名高血压患者分为减盐行为准备度较高和较低的两组(分别为向上(UP)组和向下(DN)组)。然后,我们研究了 TTM 阶段的变化与 12 个月内每日盐摄入量和血压变化之间的关系。UP组患者的尿钾浓度明显增加(从基线时的51.2 ± 23.3 mEq/L增加到12个月时的56.9 ± 25.5 mEq/L;P = 0.048),估计的24小时尿盐排泄量明显减少(从基线时的9.7 ± 2.9克/天减少到12个月时的8.4 ± 2.8克/天;P = 0.045)。此外,他们的尿钠浓度变化也显著降低(-13.1 ± 46.1 vs. -6.6 ± 59.7 mEq/L;P = 0.048),尿钾浓度变化显著增加(5.7 ± 20.1 vs. -4.8 ± 28.6 mEq/L;P = 0.030),与 DN 组患者相比,估计的 24 小时尿盐排泄量明显减少(-1.3 ± 2.6 vs. -0.1 ± 2.6 g/天;P = 0.045)。然而,他们的家庭血压在 12 个月内没有改善。在 12 个月内,减盐意愿增强或保持较高减盐意愿的高血压患者的每日钾摄入量显著增加,每日盐摄入量显著减少。
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引用次数: 0
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Blood Pressure Monitoring
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