在重症监护室的皮肤颜色和脉冲氧计精度:试点前性研究
medRxiv : the preprint server for health sciences
|November 28, 2023
概括
脉冲氧计的不准确性在皮肤较黑的ICU患者中更高. 在各种人群中测试设备对于所有患者的精确氧和度读数至关重要.
科学领域:
- 医疗器械 医疗器械
- 关键护理医学 关键护理医学
- 身体生理学 身体生理学
背景情况:
- 脉冲氧计是监测氧和度的标准工具.
- 在皮肤颜色较暗的个体中报告了脉冲氧计的不准确性.
- 目前的监管测试通常使用健康的志愿者,而不是重症患者.
研究的目的:
- 评估脉冲氧计在重症监护室 (ICU) 患者的精度,这些患者的皮肤颜色不同.
- 为了确定皮肤颜色是否会影响临床环境中的脉冲氧计读数.
主要方法:
- 使用染色仪测量皮肤颜色,并计算个人类型角度 (ITA).
- 精确匹配脉冲氧计 (SpO2) 与使用动脉线波形的动脉血液气体 (SaO2) 采样.
- 计算错误 (SpO2-SaO2),偏差和平均根的平均平方误差 (ARMS).
- 使用多变量线性混合效应模型来评估SpO2-SaO2与皮肤色素之间的关联.
主要成果:
- 颜色较暗的个体 (额头ITA<-30°) 显示1.05%的偏差和4.15%的ARMS,而颜色较浅的个体则显示0.34%的偏差和1.97%的ARMS.
- 在调整后,SPO2在黑色素质个体中错误地增加了1.00%.
- 在前额,前臂和手指的各种较深的皮肤色调中,观察到SPO2对SaO2的显著高估.
结论:
- 脉冲氧计在深色素,危急病患者的表现比FDA的清除标准要差.
- 临床测试脉冲氧计在ICU设置是可行的和建议的.
- 监管机构应该考虑要求在各种皮肤颜色上进行设备测试,以确保公平的性能.
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