Key result
Omron Evolv and M3 Comfort pass clinical BP validation in pregnancy, including pre-eclampsia.
Why the study?
Do the Omron Evolv and Omron M3 Comfort devices accurately measure blood pressure compared to a mercury standard in pregnant women with and without hypertensive disorders?
Observational (n=90)
Single-blind
No
Do the Omron Evolv and Omron M3 Comfort devices accurately measure blood pressure compared to a mercury standard in pregnant women with and without hypertensive disorders?
The Omron Evolv and Omron M3 Comfort devices fulfill the Universal Standard Protocol criteria for clinical accuracy in pregnancy and pre-eclampsia, supporting their use for home blood pressure monitoring in this population.
Answers are grounded in this paper and cite their sources.
May support home BP monitoring with these devices in pregnancy; leaves open need for outcome trials.
BACKGROUND: Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy. OBJECTIVE: (HEM-7134-E) devices in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol. METHODS: Both devices, the Evolv and the M3 Comfort, measure BP at the brachial level using the oscillometric method. The study was performed according to the recently published protocol, the so-called "modified Advancement of Medical Instrumentation (AAMI)/British Hypertension Society (BHS)/European Society of Hypertension (ESH) protocol" or the "Universal Standard Protocol." Validation of each device included 45 pregnant women in the second and third gestational trimester of whom 15 had pre-eclampsia, 15 had gestational hypertension and 15 were normotensives. BP differences between the observer and the device BP values were classified into three categories (≤5, ≤10, and ≤15 mmHg) and the mean BP differences (test vs reference) and its SD were calculated. RESULTS: Both devices, the Evolv and the M3 Comfort, achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device BP values in pregnancy were: 1) for the Evolv of -0.7±2.3 mmHg for systolic blood pressure (SBP) and -0.1±1.8 mmHg for diastolic blood pressure (DBP); 2) for the M3 Comfort of -1.6±2.8 mmHg for SBP and -0.1±2.3 mmHg for DBP. CONCLUSION: Both devices, the Evolv and the M3 Comfort, achieved a grade A/A for both SBP and DBP and fulfill the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.
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Topouchian et al. (2018) conducted an observational in Pregnancy, Pre-eclampsia, Gestational Hypertension (n=90). Omron Evolv and Omron M3 Comfort automated blood pressure monitors vs. Mercury sphygmomanometer was evaluated on Mean difference between device and standard mercury sphygmomanometer for systolic blood pressure (MD -0.7 ± 2.3 mmHg). Both the Omron Evolv and Omron M3 Comfort devices achieved an A/A validation grade for systolic and diastolic blood pressure accuracy compared to mercury sphygmomanometry in pregnant women, including those with pre-eclampsia.
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