作为反射脉冲氧计的Empatica EmbracePlus腕带的未来临床验证
Giulia Gerboni1, Giulia Comunale1, Weixuan Chen1
1Empatica, Inc., Cambridge, MA, United States.
在受控缺氧期间,EmbracePlus腕带准确地测量了不同个体的外周氧和 (SpO2). 这种可穿戴设备显示了持续氧气监测的临床有效性,有助于早期检测低氧症.
科学领域:
- 生物医学工程 生物医学工程
- 心肺生理学 心肺生理学
- 医疗器械技术 医疗器械技术
背景情况:
- 呼吸系统疾病可以降低动脉氧和度 (SaO2),需要持续监测以检测低氧症.
- 可穿戴的脉冲氧度仪器提供非侵入性的外周氧和 (SpO) 监测.
- 临床验证至关重要,特别是在不同种族群体的表现方面.
研究的目的:
- 为了对EmbracePlus腕带反射脉冲氧计功能的准确性进行前性验证.
- 根据ISO 80601-2-61:2017和FDA指南,在受控的低氧条件下评估设备的性能.
- 为了评估不同皮肤颜色和性别人口统计数据的准确性.
主要方法:
- 健康的成年参与者接受了受控的脱协议 (SaO2100%到70%).
- 将EmbracePlus腕带SpO2的测量与来自同氧度血液分析的参考SaO2进行了比较.
- 数据包括30%的菲茨帕特里克皮肤类型V-VI的参与者.
主要成果:
- 该研究实现了2.4%的精度平方根平均值 (rms) 误差,低于FDA的3.5%限制.
- 在SpO2和SaO2之间观察到强烈的正相关性 (r=0.96) 和良好的一致性 (bias 0.05%,SD 1.66%).
- 准确度在菲茨帕特里克皮肤类型 (V-VI的2.2%) 和性别之间仍然可以接受.
结论:
- 在特定条件下,EmbracePlus腕带在不同个体的SPO评估中表现出临床上可接受的准确性.
- 这些发现支持其在各种人群中用于持续氧气监测的潜在用途.
- 需要在不健康的受试者和门诊环境中进一步验证.
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