BACKGROUND AND OBJECTIVE: The present study compares the accuracy of a new continuous venous oxygenation monitoring system (PediaSat Oximetry Catheter) with laboratory blood oximetry in paediatric surgical patients. METHODS: Children and adolescents undergoing cardiac, orthopaedic or craniofacial surgery with major blood loss were included. A 4.5 Fr two-lumen or 5.5 Fr three-lumen central venous oximetry catheter (SPediaSatcvO2) was inserted preoperatively into the superior vena cava. After in-vivo calibration of the PediaSat system, repeated blood samples were obtained from the distal port of the venous catheter and oximetrically analysed for haemoglobin and central venous oxygen saturation (SCO-OXcvO2). Central venous oxygen saturation values measured by the PediaSat (SPediaSatcvO2) were compared with co-oximetry (SCO-OXcvO2) values from the simultaneously taken blood samples by Bland-Altman and simple regression analyses. RESULTS: Overall, 142 data pairs from 27 patients, aged from 0.6 to 19.0 years (median 5.3 years) were analysed. SPediaSatcvO2 and SCO-OXcvO2 values ranged from 57 to 98% and from 57.1 to 95.8%, respectively. Correlation between SPediaSatcvO2 and SCO-OXcvO2 was poor with r equal to 0.28 (P < 0.0001). SPediaSatcvO2 overestimated SCO-OXcvO2 (mean bias +2.6%), but limits of agreement (+/-2 SD of bias) were unacceptably high (-14.4/+19.6%). Sensitivity and specificity of SPediaSatcvO2 to indicate a fall or rise of SCO-OXcvO2 between two subsequent measurements were only 0.42 and 0.24, respectively. CONCLUSION: In paediatric and adolescent patients undergoing major surgery, the PediaSat system did not reliably reflect SCO-OXcvO2 values and cannot replace repeated invasive ScvO2 assessments in the clinically relevant range of ScvO2.