Schoot Tessa S, Weenk Mariska, van de Belt Tom H, Engelen Lucien J L P G, van Goor Harry, Bredie Sebastian J H
Radboud University Medical Center, Department of Internal Medicine, Radboud University, Nijmegen, Netherlands.
J Med Internet Res. 2016 May 5;18(5):e85. doi: 10.2196/jmir.5414.
Cuffless blood pressure (BP) monitoring devices, based on pulse transit time, are being developed as an easy-to-use, more convenient, fast, and relatively cheap alternative to conventional BP measuring devices based on cuff occlusion. Thereby they may provide a great alternative to BP self-measurement.
The objective of our study was to evaluate the performance of the first release of the Checkme Health Monitor (Viatom Technology), a cuffless BP monitor, in a real-life setting. Furthermore, we wanted to investigate whether the posture of the volunteer and the position of the device relative to the heart level would influence its outcomes.
Study volunteers fell into 3 BP ranges: high (>160 mmHg), normal (130-160 mmHg), and low (<130 mmHg). All requirements for test environment, observer qualification, volunteer recruitment, and BP measurements were met according to the European Society of Hypertension International Protocol (ESH-IP) for the validation of BP measurement devices. After calibrating the Checkme device, we measured systolic BP with Checkme and a validated, oscillometric reference BP monitor (RM). Measurements were performed in randomized order both in supine and in sitting position, and with Checkme at and above heart level.
We recruited 52 volunteers, of whom we excluded 15 (12 due to calibration failure with Checkme, 3 due to a variety of reasons). The remaining 37 volunteers were divided into low (n=14), medium (n=13), and high (n=10) BP ranges. There were 18 men and 19 women, with a mean age of 54.1 (SD 14.5) years, and mean recruitment systolic BP of 141.7 (SD 24.7) mmHg. BP results obtained by RM and Checkme correlated well. In the supine position, the difference between the RM and Checkme was >5 mmHg in 17 of 37 volunteers (46%), of whom 9 of 37 (24%) had a difference >10 mmHg and 5 of 37 (14%) had a difference >15 mmHg.
BP obtained with Checkme correlated well with RM BP, particularly in the position (supine) in which the device was calibrated. These preliminary results are promising for conducting further research on cuffless BP measurement in the clinical and outpatient settings.
基于脉搏传输时间的无袖带血压监测设备正在被开发，作为一种易于使用、更便捷、快速且相对便宜的替代基于袖带阻断的传统血压测量设备的产品。因此，它们可能为血压自我测量提供一个很好的选择。
我们研究的目的是在实际环境中评估首款Checkme健康监测仪（维动科技）——一种无袖带血压监测仪的性能。此外，我们想研究志愿者的姿势以及设备相对于心脏水平的位置是否会影响其测量结果。
研究志愿者分为3个血压范围：高血压（>160 mmHg）、正常血压（130 - 160 mmHg）和低血压（<130 mmHg）。根据欧洲高血压学会国际协议（ESH - IP）对血压测量设备进行验证时，满足了测试环境、观察者资格、志愿者招募和血压测量的所有要求。校准Checkme设备后，我们使用Checkme和经过验证的示波参考血压监测仪（RM）测量收缩压。测量在仰卧位和坐位随机进行，并将Checkme置于心脏水平及以上位置。
我们招募了52名志愿者，其中排除了15名（12名因Checkme校准失败，3名因各种原因）。其余37名志愿者分为低血压组（n = 14）、中血压组（n = 13）和高血压组（n = 10）。有18名男性和19名女性，平均年龄为54.1（标准差14.5）岁，平均招募时收缩压为141.7（标准差24.7）mmHg。RM和Checkme获得的血压结果相关性良好。在仰卧位时，37名志愿者中有17名（46%）RM与Checkme之间的差异>5 mmHg，其中37名中有9名（24%）差异>10 mmHg，37名中有5名（14%）差异>15 mmHg。
Checkme获得的血压与RM血压相关性良好，特别是在设备校准的位置（仰卧位）。这些初步结果为在临床和门诊环境中对无袖带血压测量进行进一步研究带来了希望。
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