Validation of the wrist blood pressure measuring device Omron RS6 (HEM-6221-E) among obese Sudanese patients according to the European Society of Hypertension International Protocol Revision 2010

Abstract

Background: Electronic devices for measuring blood pressure (BP) need to go through independent clinical validation as recommended by different authorities, both in general and specific populations. The aim of this study was to assess the validity of the Omron RS6 (HEM-6221-E) wrist oscillometric devices in obese Sudanese patients. Methods: Of 90 obese individuals invited for recruitment, 33 were included in the study, and had their BP at the level of the wrist measured using Omron RS6 and standard mercury sphygmomanometer. Two observations were made and the mean was taken. BP differences between the two methods for the 33 participants were classified into three categories (≤5, ≤10, and ≤15 mmHg), according to the European Society of Hypertension-International Protocol revision 2010 (ESH-IP2) criteria. This was then used to assess the validity of the tested Omron RS6 device. Results: Participants had a mean age of 56.97 years (standard deviation (SD), 8.75; range, 36-79). Average systolic blood pressure (SBP) was 146.21 mmHg (SD, 23.07; range, 107-182), and average diastolic blood pressure (DBP) was 93.82 mmHg (SD, 16.06; range, 67-128). There was a good agreement between the two observations using the OMRON RS6 and the standard sphygmomanometer: −4 to + 3 mmHg for SBP and −4 to +4 mmHg for DBP, with the mean difference of 1.73±1.11 mmHg for SBP and 1.49±1.02 mmHg for DBP. Conclusion: Thus, the Omron RS6 (HEM-6221-E) is a valid and suitable measure of BP according to ESH-IP2.