Tamura Toshiyo, Shimizu Shigeru, Nishimura Nobuhiro, Takeuchi Masachika
Future Robotics Organization, Waseda University, Tokyo, Japan.
San-ei Medisys Co., Ltd, Kyoto, Japan.
Health Technol (Berl). 2023;13(1):53-63. doi: 10.1007/s12553-023-00726-6. Epub 2023 Jan 23.
Blood pressure is an important cardiovascular parameter. Currently, the cuff-based sphygmomanometer is a popular, reliable, measurement method, but blood pressure monitors without cuffs have become popular and are now available without a prescription. Blood pressure monitors must be approved by regulatory authorities. Current cuffless blood pressure (CL-BP) monitors are not suitable for at-home management and prevention of hypertension. This paper proposes simple criteria for over-the-counter CL-BP monitoring. First, the history of the sphygmomanometer and current standard blood pressure protocol are reviewed. The main components of CL-BP monitoring are accuracy during the resting condition, accuracy during dynamic blood pressure changes, and long-term stability. In this proposal we recommend intermittent measurement to ensure that active measurement accuracy mirrors resting condition accuracy. A new experimental protocol is proposed to maintain long-term stability. A medically approved automated sphygmomanometer was used as the standard device in this study. The long-term accuracy of the test device is based on the definition of propagation error, i.e., for an oscillometric automated sphygmomanometer (5 ± 8 mmHg) ± the error for the test device static accuracy (-0.12 ± 5.49 mmHg for systolic blood pressure and - 1.17 ± 5.06 mmHg for diastolic blood pressure). Thus, the long-term stabilities were - 3.38 ± 7.1 mmHg and - 1.38 ± 5.4 mmHg, which satisfied propagation error. Further research and discussion are necessary to create standards for use by manufacturers; such standards should be readily evaluated and ensure high-quality evidence.
The online version contains supplementary material available at 10.1007/s12553-023-00726-6.
血压是一项重要的心血管参数。目前，基于袖带的血压计是一种常用、可靠的测量方法，但无袖带血压监测仪已开始流行，且现在无需处方即可获得。血压监测仪必须经过监管机构的批准。目前的无袖带血压（CL-BP）监测仪不适合用于家庭高血压管理和预防。本文提出了非处方CL-BP监测的简单标准。首先，回顾了血压计的历史和当前的标准血压测量方案。CL-BP监测的主要组成部分包括静息状态下的准确性、动态血压变化时的准确性以及长期稳定性。在本建议中，我们推荐采用间歇性测量，以确保主动测量准确性反映静息状态准确性。提出了一种新的实验方案以维持长期稳定性。本研究中使用经医学批准的自动血压计作为标准设备。测试设备的长期准确性基于传播误差的定义，即对于示波自动血压计（5±8 mmHg）±测试设备静态准确性的误差（收缩压为-0.12±5.49 mmHg，舒张压为-1.17±5.06 mmHg）。因此，长期稳定性分别为-3.38±7.1 mmHg和-1.38±5.4 mmHg，满足传播误差。制造商制定使用标准还需要进一步的研究和讨论；此类标准应易于评估并确保高质量证据。
在线版本包含可在10.1007/s12553-023-00726-6获取的补充材料。
