Fawzy Ashraf, Ali Harith, Dziedzic Peter H, Potu Niteesh, Calvillo Eusebia, Golden Sherita H, Iwashyna Theodore J, Suarez Jose I, Hager David N, Garibaldi Brian T
medRxiv. 2023 Nov 17:2023.11.16.23298645. doi: 10.1101/2023.11.16.23298645.
Despite multiple reports of pulse oximeter inaccuracy among hospitalized Black individuals, regulatory testing of pulse oximeters is performed on healthy volunteers.
Evaluate pulse oximeter accuracy among intensive care unit patients with diverse skin pigmentation.
Skin pigmentation was measured using a chromameter in 12 patients and individual typology angle (ITA), a measure of constitutive pigmentation, calculated. Arterial blood gas (ABG) arterial oxygen saturation (SaO ) sampling was precisely matched to pulse oximetry (SpO ) using arterial line waveforms analysis. Error (SpO -SaO ), bias, and average root mean square error (A ) were calculated. Multivariable linear mixed effects models evaluated the association of SpO -SaO with skin pigmentation.
Sampling time was determined for 350 ABGs. Five participants (N=96 ABGs) were darkly pigmented (forehead ITA<-30°), and 7 lighter pigmented (N=254 ABGs). Darkly pigmented individuals had 1.05% bias and 4.15% A compared to 0.34% bias and 1.97% A among lighter pigmented individuals. After adjusting for SaO , pH, heart rate, and mean arterial pressure, SpO -SaO was falsely elevated by 1.00% more among darkly pigmented individuals (95% confidence interval: 0.25-1.76%). SpO significantly overestimated SaO for dark, brown, and tan forehead or forearm pigmentation and brown and tan finger pad pigmentation compared to intermediate/light pigmentation.
The pulse oximeter in clinical use at an academic medical center performed worse in darkly pigmented critically ill patients than established criteria for FDA clearance. Pulse oximeter testing in ICU settings is feasible, and could be required by regulators to ensure equivalent device performance by skin pigmentation among patients.
尽管有多项报告指出住院的黑人个体中存在脉搏血氧仪不准确的情况，但脉搏血氧仪的监管测试是在健康志愿者身上进行的。
评估不同皮肤色素沉着的重症监护病房患者的脉搏血氧仪准确性。
使用色度计测量12名患者的皮肤色素沉着，并计算个体类型角度（ITA），这是一种组成性色素沉着的测量方法。通过动脉管路波形分析，将动脉血气（ABG）动脉血氧饱和度（SaO₂）采样与脉搏血氧饱和度（SpO₂）精确匹配。计算误差（SpO₂ - SaO₂）、偏差和平均均方根误差（A）。多变量线性混合效应模型评估SpO₂ - SaO₂与皮肤色素沉着的关联。
确定了350次ABG的采样时间。5名参与者（N = 96次ABG）色素沉着较深（额头ITA < -30°），7名色素沉着较浅（N = 254次ABG）。与色素沉着较浅的个体相比，色素沉着较深的个体偏差为1.05%，A为4.15%，而色素沉着较浅的个体偏差为0.34%，A为1.97%。在调整了SaO₂、pH、心率和平均动脉压后，色素沉着较深的个体中SpO₂ - SaO₂错误升高了1.00%以上（95%置信区间：0.25 - 1.76%）。与中度/浅色色素沉着相比，对于深色、棕色和棕褐色的额头或前臂色素沉着以及棕色和棕褐色的指尖色素沉着，SpO₂显著高估了SaO₂。
在一家学术医疗中心临床使用的脉搏血氧仪在色素沉着较深的重症患者中表现比美国食品药品监督管理局（FDA）批准的既定标准更差。在重症监护病房环境中进行脉搏血氧仪测试是可行的，监管机构可能会要求这样做，以确保不同皮肤色素沉着的患者之间设备性能相当。
