一种基于光斑立体学无袖装置的原型显示了在跟踪血压变化方面有希望的结果
Christine Hove1,2, Frode Wirum Sæter1,3, Alexey Stepanov4
1Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Frontiers in medical technology
|November 5, 2024
概括
这项研究表明,一个无袖血压装置的原型可以跟踪健康成年人的血压变化. 虽然不是完全的验证,但它符合ISO 81060-3:2022的准确性和稳定性标准.
科学领域:
- 生物医学工程 生物医学工程
- 心血管技术的心血管技术
- 医疗器械开发 医疗器械开发
背景情况:
- 非侵入性的无袖血压 (BP) 设备提供了持续监测的潜力.
- 目前的商业和原型无袖设备缺乏根据既定标准进行验证.
- 准确的血压估计需要严格的评估,特别是在动态的生理状态.
研究的目的:
- 为了评估一个原型的无袖高血压装置的能力来跟踪BP变化.
- 将设备的性能与非侵入性连续血压监测器 (Nexfin) 进行比较.
- 通过ISO 81060-3:2022标准的指标来评估性能.
主要方法:
- 从无袖和参考设备获得连续的节奏数据采集.
- 无袖装置的单次校准使用参考BP.
- 在38名健康成年人中,通过同度运动,精神压力和冷压测试来诱导血压变化.
主要成果:
- 平均差异 (SD) 为0.3 (8.7) mmHg (静脉缩),0.04 (6.6) mmHg (透气缩) 和0.8 (7.9) mmHg (平均动脉压),符合ISO 81060-3:2022准确性标准.
- 稳定性标准得到满足,结果为1.9 (9.2) mmHg,2.9 (8.1) mmHg和2.5 (9.5) mmHg.
- 对腹压和平均动脉压的第85个百分位数满足了变化要求的标准,但对于缩血压或所有参数的第50个百分位数不满足.
结论:
- 这种无袖装置的原型显示出在健康成年人中跟踪血压波动的能力.
- 该设备显示出有希望的结果,符合ISO 81060-3:2022标准,特别是准确性和稳定性.
- 根据完整的ISO协议进行进一步验证是必要的,以确认临床效用.
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