Validation of blood pressure measurement with Medicom-Combi blood pressure monitor using oscillometric and auscultatory methods for use among adults (according to International Protocol of European Society of Hypertension for validation of blood pressure measuring devices in adults)

Abstract

Purpose. To evaluate the accuracy of measuring blood pressure (BP) by the ECG and Medicom-Combi daily blood pressure monitoring system, designed to monitor blood pressure with oscillometric and auscultatory methods, among adults in accordance with the European Hypertension Society’s International Protocol for validation of adult blood pressure measuring instruments (ESH‑2001). Materials and methods. Patients were recruited based on criteria recommended by the ESH‑2001 protocol. A total of 99 pairs of test and control measurements of blood pressure were obtained (three pairs of measurements for each of 33 subjects). The measurements were carried out sequentially on the same arm. For the arm circumference of 24–32 cm and 32–42 cm, two cuffs of the test complex were used (adult small and adult large, respectively). Results. When testing the complex, 66, 93, and 99 measurements were obtained within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 66, 89 and 95 measurements for diastolic blood pressure (DBP), respectively, using the oscillometric method, as well as 71, 93 and 97 measurements for SBP and 71, 84 and 93 measurements for DBP, respectively, when using the auscultatory method. The mean ± SD of the differences between the test and control measurements were 1.8 ± 5.4 / 1.6 ± 6.9 mmHg for SBP / DBP using the oscillometric method and 0.8 ± 5.9 / –1.2 ± 7.9 mmHg for SBP / DBP using the auscultatory method. Conclusion. The complex of daily monitoring of ECG and blood pressure Medicom-Combi, designed for daily monitoring of blood pressure, meets the requirements stated in the international protocol ESH‑2001 (class ‘Passed’) for adults and is recommended for use in clinical practice.