Department of Anesthesiology and Intensive Care, Clinique de La Sauvegarde, 80 Avenue Ben Gourion, 69009, Lyon, France.
Department of Anesthesiology, CUB Erasme University Hospital, Université Libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium.
BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0.
Arterial hypertension is a worldwide public health problem. While it is currently diagnosed and monitored non-invasively using the oscillometric method, having the ability to measure blood pressure (BP) using a smartphone application could provide more widespread access to hypertension screening and monitoring. In this observational study in intensive care unit patients, we compared blood pressure values obtained using a new optical smartphone application (OptiBP™; test method) with arterial BP values obtained using a radial artery catheter (reference method) in order to help validate the technology.
We simultaneously measured three BP values every hour for five consecutive hours on two consecutive days using both the smartphone and arterial methods. Bland-Altman and error grid analyses were used for agreement analysis between both approaches. The performance of the smartphone application was investigated using the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) definitions, which require the bias ± SD between two technologies to be below 5 ± 8 mmHg.
Among the 30 recruited patients, 22 patients had adequate OptiBP™ values and were thus analyzed. In the other 8 patients, no BP could be measured due to inadequate signals. The Bland-Altman analysis revealed a mean of the differences ± SD between both methods of 0.9 ± 7 mmHg for mean arterial pressure (MAP), 0.2 ± 14 mmHg for systolic arterial pressure (SAP), and 1.1 ± 6 mmHg for diastolic arterial pressure (DAP). Error grid analysis demonstrated that the proportions of measurement pairs in risk zones A to E were 88.8% (no risk), 10% (low risk), 1% (moderate risk), 0% (significant risk), and 0% (dangerous risk) for MAP and 88.4%, 8.6%, 3%, 0%, 0%, respectively, for SAP.
This method comparison study revealed good agreement between BP values obtained using the OptiBP™ and those done invasively. The OptiBP™ fulfills the AAMI/ISO universal standards for MAP and DAP (but not SAP). Error grid showed that the most measurements (≥ 97%) were in risk zones A and B.
ClinicalTrials.gov registration: NCT04728477.
动脉高血压是一个全球性的公共卫生问题。目前，它通过示波法进行无创诊断和监测，而使用智能手机应用程序测量血压（BP）的能力可以更广泛地用于高血压筛查和监测。在这项重症监护病房患者的观察性研究中，我们比较了使用新的光学智能手机应用程序（OptiBP™；测试方法）和桡动脉导管（参考方法）获得的血压值，以帮助验证该技术。
我们在连续两天内，每小时使用智能手机和动脉方法同时测量三次血压，共连续测量五次。使用 Bland-Altman 和误差网格分析来分析两种方法之间的一致性。使用医疗器械促进协会（AAMI）和国际标准化组织（ISO）的定义来研究智能手机应用程序的性能，这些定义要求两种技术之间的偏差±SD 应低于 5±8mmHg。
在招募的 30 名患者中，有 22 名患者有足够的 OptiBP™ 值，因此对其进行了分析。在其他 8 名患者中，由于信号不足，无法测量血压。Bland-Altman 分析显示，两种方法之间的平均差异分别为平均动脉压（MAP）为 0.9±7mmHg，收缩压（SAP）为 0.2±14mmHg，舒张压（DAP）为 1.1±6mmHg。误差网格分析表明，MAP 的测量对 A 到 E 风险区的比例为 88.8%（无风险），10%（低风险），1%（中风险），0%（显著风险）和 0%（危险风险），SAP 分别为 88.4%，8.6%，3%，0%，0%。
这项方法比较研究显示，使用 OptiBP™ 和侵入性方法获得的 BP 值具有良好的一致性。OptiBP™ 满足 AAMI/ISO 对 MAP 和 DAP（但不是 SAP）的通用标准。误差网格显示，大多数测量值（≥97%）位于风险区 A 和 B。
ClinicalTrials.gov 注册：NCT04728477。
