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Excerpt

This study aimed to calibrate and validate an advanced technology near-infrared cerebral oximeter for use in children with congenital heart disease. One hundred children less than 12 years and less than 40 kg were enrolled. Phase I (calibration) measured arterial and jugular venous saturation (SaO₂, SjO₂) by co-oximetry simultaneously with device signals to calibrate an algorithm to determine regional cerebral saturation against a weighted average cerebral saturation (0.7 SjO₂ + 0.3 SaO₂). Phase II (validation) evaluated regional cerebral saturation from the algorithm against the weighted average cerebral saturation by correlation, bias, precision, and A_{Root Mean Square} assessed by linear regression and Bland-Altman analysis. Of 100 patients, 86 were evaluable, consisting of 7 neonates, 44 infants, and 35 children of whom 55 % were female, 79 % Caucasian, and 41 % with cyanotic disease. The SaO₂ and regional cerebral saturation ranged from 34 to 100 % and 34 to 91 %, respectively. There were no significant differences in subject characteristics between phases. For the entire cohort, A_RMS, bias, precision, and correlation coefficient were 5.4, 0.5, 5.39, and 0.88 %, respectively. Age, skin color, and hematocrit did not affect these values. …