BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine

The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants undergoing elective coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). The investigation aims to verify the claim that real-time detection and correction of cerebral autoregulation (CA) impairment during CPB improves neurological outcomes compared to standard perioperative management. The study is designed to demonstrate superiority of BrainProtect-guided management over standard care. This is a Multicenter, two-arm, blinded, randomized controlled pivotal (confirmatory) clinical investigation of a non-CE marked investigational medical device. Adult participants undergoing elective coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) will be randomized in a 1:1 ratio to either the investigational group or the control group. In the investigational group, standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB. In the control group, standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team. Postoperative neurological outcomes (POCD and POD) will be assessed in both groups using predefined standardized neuropsychological tests and CAM-ICU assessments during the early postoperative period. In addition, the length of the index hospitalisation and occurrence of hospital readmission within 31 days after surgery and the reason for readmission will be recorded.

Inclusion Criteria: 1. Age 18-69 years. 2. Patient has provided written informed consent to participate in the study. 3. Qualification for the elective coronary artery bypass graft (CABG) surgery requiring CPB. Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding. 2. Patients with an eye disease that may affect monitoring results, as determined by the Investigator. 3. Patient who had an orbital or eye injury. 4. Patients who have acute or chronic but currently exacerbated respiratory disease. 5. Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock). 6. Patients with cognitive impairments which could be associated with POD were diagnosed prior to surgery. 7. Patients with a history of clinically significant neurological or cognitive disorders that may interfere with neurocognitive assessment, including dementia, Alzheimer's disease, Parkinson's disease, or recurrent or persistent delirium within the last 12 months. 8. Patients who are receiving psychotropic medications. 9. It is not possible to perform a qualitative neuropsychological assessment due to other factors (e.g., hearing or vision impairments).