Department of Pediatrics and Pediatric Health Center, Albert Szent-Györgyi Health Centre, University of Szeged Albert Szent-Györgyi Medical School, Korányi fasor, Szeged, Hungary.
Blood Press Monit. 2024 Aug 1;29(4):198-202. doi: 10.1097/MBP.0000000000000701. Epub 2024 Mar 11.
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.
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.
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.
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.
动态血压监测（ABPM）设备在诊断高血压方面发挥着至关重要的作用，不仅在成人中，在儿科患者中也是如此。Meditech Ltd.（匈牙利布达佩斯）的最新袖带法设备 ABPM-06 是本研究的重点。本研究的目的是使用国际标准化组织（ISO）81060-2：2018 标准验证 ABPM-06 设备。
共有 86 名健康患者，包括 34 名男性和 52 名女性，年龄在 3 至 17 岁之间，入组本研究。在动态监测阶段，共纳入 50 名患者，其中 35 名患者年龄在 3 至 12 岁之间，15 名患者年龄在 12 至 17 岁之间。此外，为了进行动态测试，选择了 36 名患者，其中 10 名年龄在 3 至 12 岁之间，26 名年龄在 12 至 17 岁之间。这些患者均来自匈牙利塞格德阿尔伯特·圣捷尔吉大学儿科门诊。验证过程涉及在休息位置和应激测试中使用相同手臂序列方案。
ABPM-06 在临床和动态验证中表现良好。在验证标准 1 方面，对于年龄在 12 岁以下的儿童，测试设备与参考血压读数之间的差异的平均值±标准差为收缩压-1.3±3.5mmHg，舒张压-0.1±2.3mmHg。对于年龄在 12 岁以上的患者，收缩压的平均值±标准差为-2.8±4.6mmHg，舒张压为-0.5±2.7mmHg。关于动态验证，对于年龄在 12 岁以下的儿童，收缩压的平均值±标准差为-1.3±3.5mmHg，舒张压为-0.1±2.3mmHg。对于年龄在 12 岁以上的患者，收缩压的平均值±标准差为-2.8±4.6mmHg，舒张压为-0.5±2.7mmHg。这两个测试都成功地满足了设备读数与观察到的 SBP 和 DBP 测量值之间差异的平均值和标准差值的既定标准。
ABPM-06 袖带法设备完全符合 ISO 81060-2：2018 标准在儿科人群（3-17 岁）中进行 ABPM 测定的要求。因此，这种 ABPM 设备适用于有效管理儿童和青少年的高血压。
