Facultad de Enfermería, Fisioterapia y Podología, Universidad de Complutense de Madrid, Madrid, Spain.
Faculty of Health Sciences, Universidad Rey Juan Carlos, Alcorcón, Spain.
JMIR Mhealth Uhealth. 2020 Apr 2;8(4):e14702. doi: 10.2196/14702.
Hypertension is a global public health issue and is closely related to chronic kidney disorder (CKD). In people with CKD, strict monitoring of blood pressure is an important part of therapy.
The aim of this research was to validate the iHealth Track blood pressure monitoring device for patients with CKD according to the European Society of Hypertension International Protocol 2010 (ESH-IP2).
In total, 33 patients who received hemodialysis in Plasencia participated in the study. There were 9 successive measurements made, which conformed to the ESH-IP2. We calculated the differences between the standard reference device (Omron M3 Intellisense) and the test device (iHealth Track) for blood pressure and heart rate values. For 99 total comparisons of paired measurements, we classified differences into various categories (≤5 mmHg, ≤10 mmHg, and ≤15 mmHg for blood pressure; ≤3, ≤5, and ≤8 beats per minute for heart rate).
In 90 of 99 systolic blood pressure and 89 of 99 diastolic blood pressure comparisons between the devices, measurement differences were within 5 mmHg. In 81 of 99 heart rate comparisons between the devices, measurement differences were within 3 beats per minute. The mean differences between the test and reference standard measurements were 3.27 (SD 2.99) mmHg for systolic blood pressure, 3.59 (SD 4.55) mmHg for diastolic blood pressure, and 2.18 (SD 2.75) beats per minute for heart rate. We also observed that for both systolic and diastolic blood pressure, 31 of 33 participants had at least two of three comparisons between the devices with measurement differences less than 5 mmHg. For heart rate, 28 of 33 patients had at least two of three comparisons between the devices with measurement differences less than 3 beats per minute.
To our knowledge, this is the first study to show that iHealth Track meets the requirements of the ESH-IP2 in patients with CKD. Therefore, the iHealth Track is suitable for use in renal patients.
高血压是一个全球性的公共卫生问题，与慢性肾脏病（CKD）密切相关。在 CKD 患者中，严格监测血压是治疗的重要组成部分。
本研究旨在根据欧洲高血压学会国际协议 2010 年（ESH-IP2）验证 iHealth Track 血压监测仪在 CKD 患者中的适用性。
共有 33 名在普拉森西亚接受血液透析的患者参与了这项研究。共进行了 9 次连续测量，符合 ESH-IP2 要求。我们计算了标准参考设备（欧姆龙 M3 Intellisense）和测试设备（iHealth Track）之间血压和心率值的差异。对于 99 次配对测量的 99 个总比较，我们将差异分为不同类别（血压≤5mmHg、≤10mmHg 和≤15mmHg；心率≤3、≤5 和≤8 次/分钟）。
在 99 次收缩压和 99 次舒张压的设备比较中，有 90 次测量差值在 5mmHg 以内。在 99 次设备间心率比较中，有 81 次差值在 3 次/分钟以内。测试和参考标准测量之间的平均差值为收缩压 3.27（SD 2.99）mmHg、舒张压 3.59（SD 4.55）mmHg 和心率 2.18（SD 2.75）次/分钟。我们还观察到，对于收缩压和舒张压，33 名参与者中有 31 名至少有两次设备间差值小于 5mmHg 的比较。对于心率，33 名患者中有 28 名至少有两次设备间差值小于 3 次/分钟的比较。
据我们所知，这是第一项表明 iHealth Track 符合 CKD 患者 ESH-IP2 要求的研究。因此，iHealth Track 适用于肾病患者。
