Email this article 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
- Authors: Fedorova S.I.1, Kulakov N.V.1, Pronina V.P.1, Tyurina T.K.1, Kotova Y.V.1
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Affiliations:
- Moscow Regional Research and Clinical Institute (MONIKI)
- Issue: No 43 (2015)
- Pages: 46-51
- Section: ARTICLES
- URL: https://almclinmed.ru/jour/article/view/102
- DOI: https://doi.org/10.18786/2072-0505-2015-43-46-51
- ID: 102
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Abstract
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”.
About the authors
S. I. Fedorova
Moscow Regional Research and Clinical Institute (MONIKI)
Author for correspondence.
Email: fsi120@yandex.ru
FedorovaSvetlanaI.– PhD, Head of Department of Functional Diagnostics
* 61/2–9 Shchepkina ul.,Moscow, 129110,Russian Federation. Tel.: +7 (495) 681 55 71. E-mail: fsi120@yandex.ru
Russian FederationN. V. Kulakov
Moscow Regional Research and Clinical Institute (MONIKI)
Email: fsi120@yandex.ru
Kulakov Nikolay V. – Physician, Department of Functional Diagnostics
Russian FederationV. P. Pronina
Moscow Regional Research and Clinical Institute (MONIKI)
Email: fsi120@yandex.ru
Pronina Viktoriya P. – PhD, Senior Research Fellow, Department of Functional Diagnostics
Russian FederationT. K. Tyurina
Moscow Regional Research and Clinical Institute (MONIKI)
Email: fsi120@yandex.ru
Tyurina Tamara K. – PhD, Senior Research Fellow, Department of Pediatrics
Russian FederationYu. V. Kotova
Moscow Regional Research and Clinical Institute (MONIKI)
Email: fsi120@yandex.ru
Kotova Yuliya V. – PhD, Assistant, Chair of Pediatrics, Postgraduate Training Faculty
Russian FederationReferences
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