Alʹmanah Kliničeskoj Mediciny (Feb 2016)

VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES IN CHILDREN AND ADOLESCENTS, ACCORDING TO ESH-IP2, BHS AND AAMI PROTOCOLS

  • S. I. Fedorova,
  • N. V. Kulakov,
  • V. P. Pronina,
  • T. K. Tyurina,
  • Yu. V. Kotova

DOI
https://doi.org/10.18786/2072-0505-2015-43-46-51
Journal volume & issue
Vol. 0, no. 43
pp. 46 – 51

Abstract

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Background: High blood pressure in childhood and adolescence is associated with a 2 to 3-fold increase of the risk of arterial hypertension. According to the Russian guidelines, only devices that have been tested by international protocols can be used for the main diagnostic method of arterial hypertension in children and adolescents, i.e. ambulatory 24-hour blood pressure monitoring.Aim: To validate the MECG-DP-NS-01 upper arm BP monitor in oscillometry and auscultation modes within the “Soyuz” complex, in children and adolescents aged from 5 to 15 years according to the international protocol of the European Society of Hypertension (ESH) from 2010 (ESH-IP2), the protocol of the British Hypertension Society (BHS) from 1993 and the standard of the Association for the Advancement of Medical Instrumentation (AAMI).Materials and methods: We recruited 99 children and adolescents (49 male, 50 female) aged from 5 to 15 years (33 children, from 5 to 7 years, 33, from 8 to 11 years, 33, from 12 to 15 years). Expert and device blood pressure measurements were performed in each patient according to the protocols.Results: The MECG-DP-NS-01 upper arm blood pressure monitor was validated and its accuracy in blood pressure measurement in children and adolescents according to ESH-IP2, BHS and AAMI protocols confirmed. According to BHS 1993 protocol, its accuracy corresponded to A/A both in the oscillometry and auscultation modes.Conclusion: According to ESH-IP2, BHS and AAMI protocols, MEGC-DP-NS-01 within the “Soyuz” complex could be recommended for 24-hour ambulatory blood pressure monitoring in children and adolescents aged from 5 to 15 years, both in the oscillometry and auscultation modes. According to the Declaration of blood pressure Measuring Device Equivalence signed by the manufacturer for the devices MDP-NS-02s “Voshod” and MEGCDPNS-01, and to the equivalence criteria for blood pressure measuring devices, the results of testing and its conclusion could be extrapolated to the device MDP-NS-02s “Voshod” produced by the “DMS Advanced Technologies”.

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