Medical Devices: Evidence and Research (Dec 2017)

Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP)

  • Chahine MN,
  • Topouchian J,
  • Zelveian P,
  • Hakobyan Z,
  • Melkonyan A,
  • Azaki A,
  • Diab R,
  • Harb A,
  • Asmar R

Journal volume & issue
Vol. Volume 11
pp. 11 – 20

Abstract

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Mirna N Chahine,1,2 Jirar Topouchian,3,4 Parounak Zelveian,3 Zoya Hakobyan,3 Arevik Melkonyan,3 Alaa Azaki,1 Reem Diab,1 Aya Harb,1 Roland Asmar1,2 1Faculty of Medical Sciences, Lebanese University, Hadath, Lebanon; 2Foundation-Medical Research Institutes (F-MRI), Beirut, Lebanon; 3Preventive Cardiology Center, Yerevan, Armenia; 4Diagnostic Center, Hotel-Dieu Hospital, Paris, France Background: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. Methods: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely. Results: QardioArm® and Omron M6 Comfort® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm® and −1.4±4.7 mmHg for SBP and −2.1±4.3 mmHg for DBP for Omron M6 Comfort®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort®.Conclusion: QardioArm® and Omron M6 Comfort® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively. Keywords: QardioArm®, Omron M6 Comfort®, validation, blood pressure measurement, type II diabetes, International Protocol

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