Validation of a Novel NeurOsTM Cerebral Oximetry Monitor Against the INVOSTM Monitor During Cardiac Surgery

OBJECTIVES To compare the performance of a novel NeurOs cerebral oximetry monitor against the INVOS monitor during the entire intraoperative phase of cardiac surgery, including periods of known fluctuation in brain oxygenation, such as preoxygenation, induction, cannulation, and cardiopulmonary bypass. DESIGN This study was a prospective, nonrandomized, healthcare-provider and outcome-assessor blinded study. SETTING Tertiary care university hospital; single institutional study. PARTICIPANTS Twenty-three patients who underwent cardiac surgery with cardiopulmonary bypass. INTERVENTIONS Both self-adhesive INVOS sensors and the assembled NeurOs sensors were placed accordingly when the patient arrived in the operating room. MEASUREMENTS AND MAIN RESULTS Ten out of 13 cases under the normal mode and eight out of the 10 cases under the high- sensitivity mode showed significant correlations between the NeurOs and INVOS groups (p < 0.05, r value from 0.24-0.88). When all cases were combined, NeurOs demonstrated significant correlation with INVOS (r = 0.5, 95% confidence interval [CI] 0.44-0.56, p < 0.01 for normal mode; r = 0.69, 95% CI 0.64 to 0.74, p < 0.01 for high-sensitivity mode) in both modes. To evaluate the data diversity, the authors performed a cluster analysis and found much less variation existed in the NeurOs normal mode when compared with INVOS (standard deviation [SD] 16.6% in INVOS, 4% in NeurOs normal mode) but similar patterns in the high-sensitivity mode (SD 17.6% in INVOS, 15.2% in NeurOs high-sensitivity mode). Bland-Altman plot analysis showed that most of the data fell between ± 1.96 SD lines, which demonstrated good consistency between these two methods under both modes of NeurOs (-28.8 to 30.8 in the normal mode; -36.6 to 32.7 in high-sensitivity mode). In the normal mode of NeurOs monitoring, receiver operating characteristic analysis suggested a 2% cutoff point was most optimal from the baseline for detecting hyperoxia (sensitivity 73%; specificity 66%) and minus 1% (sensitivity 66%; specificity 67%) for detecting hypoxia. Whereas in the high-sensitivity mode, the optimal cutoff point was 3% from baseline for detecting hyperoxia (sensitivity 75%; specificity 68%), and minus 3% for detecting hypoxia (sensitivity 90%; specificity 45%). CONCLUSIONS In conclusion, the novel NeurOs system was found to correlate with INVOS cerebral oximetry measurements during cardiac surgery.