开发一种可靠的无袖测量血压(BP)的方法将是有用的,因为这种方法可以随时随地用于有效筛查和监测动脉高血压。这项研究的目的是评估不同患者组的临床实践中通过CardioQVARK设备进行的血压测量。
方法:本研究纳入167名年龄在31至88岁(平均64.2±7.8岁)血压正常的患者,高血压,补偿高血压.在每次会议期间,使用具有适当袖带尺寸的血压计以30s的间隔进行三次常规血压测量,并选择平均值进行比较。测量是由两名同时训练的观察者使用Y形连接器的参考血压计进行的。在最后一次基于袖带的测量之后的一分钟内,使用CardioQVARK装置同时记录带I导联的心电图(ECG)和光学体积心电图3分钟.我们比较了从基于袖带的汞血压计和基于智能手机的情况下的BP设备获得的收缩压和舒张压BP:CardioQVARK监测器。使用IEEE可穿戴式无袖带血压设备标准制定了统计分析计划。Bland-Altman地块用于估计无袖口测量的精度。
结果:CardioQVARK和基于袖带的血压计定义的收缩压(SBP)值之间的平均差为0.31±3.61,而舒张压(DBP)为0.44±3.76。SBP的平均绝对差(MAD)为3.44±2.5mmHg,DBP为3.21±2.82mmHg。在分组中,在高血压前期组中观察到最小的误差(小于3mmHg),在血压正常和1期高血压患者中发现的误差稍大(高达4mmHg)。在2期高血压组中发现最大的误差(4-5.5mmHg)。高血压组最大误差为4.2mmHg。我们,因此,没有记录超过7mmHg的错误,IEEE建议中认为可以接受的上限。我们也没有达到5mmHg的平均误差,根据最近的ESH建议,认为可以接受的上限。同时,在所有患者组中,超过80%的患者的收缩压测定误差小于5mmHg.虽然这项研究表明CardioQVARK设备符合IEEE的标准,Bland-Altman分析表明,无袖口测量舒张压具有明显的偏差。差异非常小,对于单个患者来说不太可能具有临床意义,但它很可能在人群水平上具有流行病学相关性。因此,CardioQVARK装置,虽然值得随着时间的推移监测患者,可能不适合筛选目的。无袖带血压测量设备正在作为基于袖带的设备的方便且可容忍的替代方案而出现。然而,无袖口血压测量设备有几个局限性,应加以考虑。例如,这项研究表明,测量误差<5mmHg的测量比例很高,当检测到一个小的,尽管具有统计学意义,舒张压测量中的偏倚。这表明该装置可能不适合用于筛选目的。然而,它随时间监测BP的价值得到了确认。此外,最重要的是,简单的测量方法和设备便携性(集成在智能手机中)可以提高高血压患者的自我意识,潜在的,导致更好的坚持他们的治疗。
结论:本研究中开发的无袖口血压技术按照IEEE协议进行了测试,在不同血压范围的患者组中显示出很高的精确度。这种方法,因此,具有应用于临床实践的潜力。
It would be useful to develop a reliable method for the cuffless measurement of blood pressure (BP), as such a method could be made available anytime and anywhere for the effective screening and monitoring of arterial hypertension. The purpose of this study is to evaluate blood pressure measurements through a CardioQVARK device in clinical practice in different patient groups.
METHODS: This study involved 167 patients aged 31 to 88 years (mean 64.2 ± 7.8 years) with normal blood pressure, high blood pressure, and compensated high blood pressure. During each session, three routine blood pressure measurements with intervals of 30 s were taken using a sphygmomanometer with an appropriate cuff size, and the mean value was selected for comparison. The measurements were carried out by two observers trained at the same time with a reference sphygmomanometer using a Y-shaped connector. In the minute following the last cuff-based measurements, an electrocardiogram (ECG) with an I-lead and a photoplethysmocardiogram were recorded simultaneously for 3 min with the CardioQVARK device. We compared the systolic and diastolic BP obtained from a cuff-based mercury sphygmomanometer and smartphone-case-based BP device: the CardioQVARK monitor. A statistical analysis plan was developed using the IEEE Standard for Wearable Cuffless Blood Pressure Devices. Bland-Altman plots were used to estimate the precision of cuffless measurements.
RESULTS: The mean difference between the values defined by CardioQVARK and the cuff-based sphygmomanometer for systolic blood pressure (SBP) was 0.31 ± 3.61, while that for diastolic blood pressure (DBP) was 0.44 ± 3.76. The mean absolute difference (MAD) for SBP was 3.44 ± 2.5 mm Hg, and that for DBP was 3.21 ± 2.82 mm Hg. In the subgroups, the smallest error (less than 3 mm Hg) was observed in the prehypertension group, with a slightly larger error (up to 4 mm Hg) found among patients with a normal blood pressure and stage 1 hypertension. The largest error was found in the stage 2 hypertension group (4-5.5 mm Hg). The largest error was 4.2 mm Hg in the high blood pressure group. We, therefore, did not record an error in excess of 7 mmHg, the upper boundary considered acceptable in the IEEE recommendations. We also did not reach a mean error of 5 mmHg, the upper boundary considered acceptable according to the very recent ESH recommendations. At the same time, in all groups of patients, the systolic blood pressure was determined with an error of less than 5 mm Hg in more than 80% of patients. While this study shows that the CardioQVARK device meets the standards of IEEE, the Bland-Altman analysis indicates that the cuffless measurement of diastolic blood pressure has significant bias. The difference was very small and unlikely to be of clinical relevance for the individual patient, but it may well have epidemiological relevance on a population level. Therefore, the CardioQVARK device, while being worthwhile for monitoring patients over time, may not be suitable for screening purposes. Cuffless blood pressure measurement devices are emerging as a convenient and tolerable alternative to cuff-based devices. However, there are several limitations to cuffless blood pressure measurement devices that should be considered. For instance, this study showed a high proportion of measurements with a measurement error of <5 mmHg, while detecting a small, although statistically significant, bias in the measurement of diastolic blood pressure. This suggests that this device may not be suitable for screening purposes. However, its value for monitoring BP over time is confirmed. Furthermore, and most importantly, the easy measurement method and the device portability (integrated in a smartphone) may increase the self-awareness of hypertensive patients and, potentially, lead to an improved adherence to their treatment.
CONCLUSIONS: The cuffless blood pressure technology developed in this study was tested in accordance with the IEEE protocol and showed great precision in patient groups with different blood pressure ranges. This approach, therefore, has the potential to be applied in clinical practice.