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

Abstract

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.