At a glance
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A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
In Brief
A clinical study evaluating Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions for Cardiac Disease and Cognitive Dysfunction. Completed, enrolled 326 participants across 2 sites.
Detailed Summary
Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.
Study Details
Timeline
Interventions
In the intervention group, an alarm threshold below 15% of the baseline rSO2 value will be established. Based on the predetermined algorithm the rSO2 will be maintained at or above 85% of the baseline measurements. If the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed to restore rSO2 to baseline levels.