Chahine Mirna N, Topouchian Jirar, Zelveian Parounak, Hakobyan Zoya, Melkonyan Arevik, Azaki Alaa, Diab Reem, Harb Aya, Asmar Roland
Faculty of Medical Sciences, Lebanese University, Hadath, Lebanon.
Foundation-Medical Research Institutes (F-MRI), Beirut, Lebanon.
Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. eCollection 2018.
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.
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.
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.
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.
按照2010年修订的欧洲高血压学会国际 protocol（ESH-IP），分别在普通人群和II型糖尿病患者中对QardioArm和欧姆龙M6 Comfort示波装置进行了自测血压（BP）评估。
QardioArm和欧姆龙M6 Comfort这两种装置均在肱动脉水平测量血压。2010年修订的ESH-IP共纳入33名受试者。对于每次测量，计算观察者测量的血压值与装置测量的血压值之间的差值。总共99对血压差值被分为三类（≤5、≤10和≤15 mmHg）。严格遵循该protocol程序。
QardioArm和欧姆龙M6 Comfort符合ESH-IP的要求并成功通过验证过程。对于QardioArm，99次收缩压（SBP）比较中共有69次的绝对差值在5 mmHg以内，99次舒张压（DBP）比较中有82次如此。至于欧姆龙M6 Comfort，99次SBP比较中共有83次的绝对差值在5 mmHg以内，99次DBP比较中有77次如此。QardioArm的装置测量值与汞柱测量值之间的平均差值，SBP为0.7±5.9 mmHg，DBP为0.3±4.1 mmHg；欧姆龙M6 Comfort的SBP为-1.4±4.7 mmHg，DBP为-2.1±4.3 mmHg。关于2010年ESH-IP的第2部分，对于QardioArm，33名受试者中有27名在三次测量中至少有两次SBP差值在5 mmHg以内，33名受试者中有31名DBP如此；对于欧姆龙M6 Comfort，33名患者中有29名在三次测量中至少有两次SBP差值在5 mmHg以内，33名患者中有26名DBP如此。
QardioArm和欧姆龙M6 Comfort的读数与汞柱标准的差值<5、10和15 mmHg符合2010年修订的ESH-IP要求。因此，这两种装置分别适用于普通人群和非胰岛素依赖型II型糖尿病患者。
