Hove Christine, Sæter Frode Wirum, Stepanov Alexey, Bøtker-Rasmussen Kasper Gade, Seeberg Trine M, Westgaard Espen, Heimark Sondre, Waldum-Grevbo Bård, Hisdal Jonny, Larstorp Anne Cecilie K
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Department of Nephrology, Oslo University Hospital, Oslo, Norway.
Front Med Technol. 2024 Oct 21;6:1464473. doi: 10.3389/fmedt.2024.1464473. eCollection 2024.
Non-invasive cuffless blood pressure devices have shown promising results in accurately estimating blood pressure when comparing measurements at rest. However, none of commercially available or prototype cuffless devices have yet been validated according to the appropriate standards. The aim of the present study was to bridge this gap and evaluate the ability of a prototype cuffless device, developed by Aidee Health AS, to track changes in blood pressure compared to a non-invasive, continuous blood pressure monitor (Human NIBP or Nexfin) in a laboratory set up. The performance was evaluated according to the metrics and statistical methodology described in the ISO 81060-3:2022 standard. However, the present study is not a validation study and thus the study was not conducted according to the ISO 81060-3:2022 protocol, e.g., non-invasive reference and distribution of age not fulfilled.
Data were sampled continuously, beat-to-beat, from both the cuffless and the reference device. The cuffless device was calibrated once using the reference BP measurement. Three different techniques (isometric exercise, mental stress, and cold pressor test) were used to induce blood pressure changes in 38 healthy adults.
The mean difference (standard deviation) was 0.3 (8.7) mmHg for systolic blood pressure, 0.04 (6.6) mmHg for diastolic blood pressure, and 0.8 (7.9) mmHg for mean arterial pressure, meeting the Accuracy requirement of ISO 81060-3:2022 (≤6.0 (10.0) mmHg). The corresponding results for the Stability criteria were 1.9 (9.2) mmHg, 2.9 (8.1) mmHg and 2.5 (9.5) mmHg. The acceptance criteria for the Change requirement were achieved for the 85th percentile of ≤50% error for diastolic blood pressure and mean arterial pressure but were higher than the limit for systolic blood pressure (56% vs. ≤50%) and for all parameters for the 50th percentile (32%-39% vs. ≤25%).
The present study demonstrated that the cuffless device could track blood pressure changes in healthy adults across different activities and showed promising results in achieving the acceptance criteria from ISO 81060-3:2022.
在静息状态下进行测量时，无创无袖带血压设备在准确估计血压方面已显示出有前景的结果。然而，尚无任何市售或原型无袖带设备根据适当标准得到验证。本研究的目的是填补这一空白，并在实验室环境中评估由Aidee Health AS开发的一款原型无袖带设备与无创连续血压监测仪（人体无创血压监测仪或Nexfin）相比追踪血压变化的能力。根据ISO 81060 - 3:2022标准中描述的指标和统计方法对性能进行了评估。然而，本研究并非验证性研究，因此该研究未按照ISO 81060 - 3:2022方案进行，例如，未满足无创参考标准和年龄分布要求。
从无袖带设备和参考设备连续逐搏采样数据。使用参考血压测量对无袖带设备进行了一次校准。采用三种不同技术（等长运动、精神应激和冷加压试验）在38名健康成年人中诱导血压变化。
收缩压的平均差值（标准差）为0.3（8.7）mmHg，舒张压为0.04（6.6）mmHg，平均动脉压为0.8（7.9）mmHg，符合ISO 81060 - 3:2022的准确性要求（≤6.0（10.0）mmHg）。稳定性标准的相应结果分别为1.9（9.2）mmHg、2.9（8.1）mmHg和2.5（9.5）mmHg。舒张压和平均动脉压误差≤50%的第85百分位数达到了变化要求的接受标准，但高于收缩压的限值（56%对≤50%）以及所有参数第50百分位数的限值（32% - 39%对≤25%）。
本研究表明，该无袖带设备能够追踪健康成年人在不同活动中的血压变化，并在达到ISO 81060 - 3:2022的接受标准方面显示出有前景的结果。
