Pulse Oximetry and Skin Tone in Children

This prospective clinical study evaluated the accuracy of pulse oximetry across skin tone variations in 320 children undergoing cardiac catheterization. Skin tone was objectively measured using a spectrophotometer, and oxygen saturation values from two pulse oximeters (Nellcor and Masimo) were compared to arterial co-oximetry measurements. Results showed that both devices consistently overestimated oxygen saturation in children with darker skin tones (individual typology angle category 5 or 6), exhibiting increased measurement bias, imprecision, and elevated root mean square error (ARMS), exceeding FDA performance thresholds. The findings underscore the potential for occult hypoxemia and call for more inclusive device validation standards to ensure equitable pediatric care.

This prospective clinical study evaluated the accuracy of pulse oximetry across skin tone variations in 320 children undergoing cardiac catheterization. Skin tone was objectively measured using a spectrophotometer, and oxygen saturation values from two pulse oximeters (Nellcor and Masimo) were compared to arterial co-oximetry measurements. Results showed that both devices consistently overestimated oxygen saturation in children with darker skin tones (individual typology angle category 5 or 6), exhibiting increased measurement bias, imprecision, and elevated root mean square error (ARMS), exceeding FDA performance thresholds. The findings underscore the potential for occult hypoxemia and call for more inclusive device validation standards to ensure equitable pediatric care.