In-vitro evaluation of the PediaSat continuous central venous oxygenation monitoring system.

BACKGROUND AND OBJECTIVE In-vitro performance of the PediaSat system for continuous monitoring of central venous oxygen saturation by spectrophotometry has been evaluated. METHODS PediaSat continuous fibre-optic oximetry catheters were inserted in a black testing chamber, connected with an extracorporeal circuit and filled with human whole blood. Oxygen inflow into the cardiopulmonary bypass system was varied, and the testing chamber was perfused with blood flow of 1000 ml min(-1). Oxygen saturation values measured by PediaSat (S PediaSat O2) were compared with cooximetry (S CO-OX O2) values from simultaneously taken blood samples by Bland-Altman and simple regression analyses. RESULTS Fifty data pairs were obtained. S PediaSat O2 and S CO-OX O2 values ranged between 28-98 and 24.9-99.5%, respectively. Correlation between S PediSat O2 and S CO-OX O2 was high with an r2 value equal to 0.96 (P < 0.0001). Overall, S PediaSat O2 only slightly overestimated S CO-OX O2 (mean bias +2.9%), and limits of agreement (+/-2 SD of bias) were acceptable (-6.8/+12.6%). Sensitivity and specificity of the first differences of S PediaSat O2 and S CO-OX O2 were 1.0 and 0.92, respectively. Subgroup analysis of S CO-OX O2 values below 70% resulted in an overestimation by S PediaSat O2, with a mean bias of +5.2% and limits of agreement of -4.7 and +15.1%. CONCLUSION The current version of the PediaSat system does not reliably reflect S CO-OX O2 values below 70%, but it seems to be a useful tool providing an accurate trend of continuous central venous oxygen saturation.