Validation of the Masimo O3™ regional oximetry device in pediatric patients undergoing cardiac surgery

We assessed the accuracy of Masimo O3™ regional cerebral oxygen saturation (rSO₂) readings by comparing them with reference values and evaluated the relationship between rSO₂ and somatic tissue oxygen saturation (StO₂) in children undergoing cardiac surgery. After anesthesia induction, pediatric sensors were applied to the forehead and foot sole, and rSO₂ and StO₂ values were monitored continuously. Before cardiopulmonary bypass (CPB), F_IO₂ was set to 0.2, 0.5, and 0.8 serially every 15 min. After CPB, F_IO₂ was reversed. The reference values (SavO₂) were calculated by combining arterial (SaO₂) and central venous oxygen saturation (SvO₂) readings from the arterial and central lines, respectively (0.7 [Formula: see text] SvO₂ + 0.3 [Formula: see text] SaO₂). In total, 265 pairs of rSO₂/StO₂ and SavO₂ from 49 patients were analyzed. The bias, standard deviation (SD), standard error (SE), and root mean squared error (RMSE) of rSO₂ were 2.6%, 4.5%, 0.3%, and 4.3%, respectively. The limits of agreement ranged from -6.3% to 11.6%. Trend accuracy analysis yielded a relative mean error of -1.4%, with an SD of 4.3%, SE of 0.2%, and RMSE of 3.9%. According to multiple linear regression analysis, the application of CPB, F_IO₂, Hb level, and tip location of the central venous catheter influenced the bias (all P < 0.05). Furthermore, the correlation between rSO₂ and StO₂ was weak (r = 0.254). rSO₂ readings by the Masimo O3™ device and pediatric sensor had good absolute and trending accuracies with respect to the calculated reference values in children undergoing cardiac surgery. rSO₂ and StO₂ cannot be used interchangeably.Clinical trial registration http://clinicaltrials.gov (number: NCT04208906).