Validation of the complex for daily monitoring of ECG and blood pressure "Medicom-Combi" for blood pressure measurement in medical institutions in the general population (according to the Universal standard AAMi / ESH / ISO UNIVERSAL)

Purpose. To assess the accuracy of blood pressure measurement by oscillometric and auscultatory methods using the complex for daily monitoring of ECG and blood pressure «Medicom-Combi» in accordance with the criteria outlined in the Universal Standard AAMI/SH/ISO (ISO 81060-2:2018) for children and adults.Materials and methods. The study involved 90 patients (average age -33.8 ± 26.7 years) of the cardiological profile of the City Clinical Hospital No. 13 DZM, Children’s City Clinical Hospital No. 9 named after G. N. Speransky, as well as medical personnel, of which 85 were included in the analysis. For each participant, 3 pairs of valid measurements were obtained (reference-test, 255 pairs of measurements in total). Reference measurements were carried out by two experts, independently of each other, using the auscultatory method. Test measurements were read from the complex by a third expert.Results. According to validation criterion 1, the mean ± standard deviation of differences between test and reference measurements was 0.1 ± 6.0/1.7 ± 5.8 mm Hg for SBP/DBP by the oscillometric method and 0.0 ± 6.5/1.3 ± 6.6 mm Hg for SBP/DBP by the auscultatory method. According to validation criterion 2, the standard deviation of the average difference between the BP values of the same patient according to the results of test and reference measurements did not exceed 6.95/6.73 for SBP/DBP by the oscillometric method and 6.95/6.82 mm Hg for SBP/DBP by the auscultatory method.Conclusion. The complex for daily monitoring of ECG and blood pressure «Medicom-Combi» meets the requirements of the Universal Standard AAMI/ESH/ISO in terms of measurement accuracy for devices intended for use among children and adults when assessing blood pressure by oscillometric and auscultatory methods.

Validation of blood pressure measurement by the complex for daily monitoring of ECG and blood pressure “Medicom-Combi" by oscillometric and auscultatory methods in pediatric population (according to the BHS-93 protocol)

Purpose. To assess the accuracy of blood pressure (BP) measurement by the complex for daily monitoring of ECG and blood pressure «MedicomCombi» in comparison with a mercury sphygmomanometer in pediatric patients.Materials and methods. The recruitment of study participants was carried out in accordance with the criteria outlined in the international protocol BHS-93 for the pediatric population. During the tests, repeated sequential measurements of blood pressure were carried out by experts (using mercury sphygmomanometers) and the tested complex (by oscillometric and auscultatory methods).Results. The mean SBP, determined by the oscillometric method, was 116.0 ± 13.6 mm Hg, DBP - 69.0 ± 11.8 mm Hg. The mean SBP according to the auscultatory method was 116.0 ± 14.6 mm Hg, DBP - 70.4 ± 11.9 mm Hg. In 66% of cases for SBP and in 62% of cases for DBP, the difference between expert and test measurements by the oscillometric method did not exceed 5 mm Hg. In 100% of cases for SBP and in 96% of cases for DBP, the differences were within 10 mm Hg. The average differences between the experts and the tested complex were - 0.2 ± 5.7 mm Hg for SBP and 1.6 ± 6.1 for DBP. In 68 % of cases for SBP and in 65 % of cases for DBP, the difference between expert and test measurements by the auscultatory method was no more than 5 mm Hg. In 100% of cases for SBP and in 95% of cases for DBP, the differences did not exceed 10 mm Hg. The average differences between the experts and the tested complex were - 0.3 ± 4.7 mm Hg for SBP and 0.1 ± 5.7 for DBP.Conclusion. The complex for daily monitoring of ECG and blood pressure «Medicom-Combi» has demonstrated compliance with the accuracy requirements specified in the BHS 1993 protocol (class «А/А»), and can be recommended for measuring blood pressure by oscillometric and auscultatory methods in pediatric practice.

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)

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.