Scienceforbrain, UAB
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.
Based on a review of the current literature and consultations regarding currently known clinical practice standards the "BrainProtect" study will be the first multicenter trial of cardiac surgery using a heart-lung machine with modulated blood flow by rectangular pulses and also with real-time cerebrovascular autoregulation monitoring. The feasibility and safety of this approach have been previously validated in two of our clinical studies. Postoperative cognitive dysfunction (POCD and POD) with incidences up to 70% and 42% respectively after cardiac surgery with cardiopulmonary bypass (CPB)…
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 card…
The BrainProtect System consists of the Archimedes 02 monitoring system, the BrainProtect Plug-in Modulator, and BrainProtect Software. The Archimedes 02 monitoring system is positioned on the participant's closed eyelids to enable non-invasive monitoring of intracranial pressure pulse waves and cerebral autoregulation-related signals. Following initiation of cardiopulmonary bypass and confirmation of stable extracorporeal circulation, the BrainProtect Plug-in Modulator is activated. Rectangular flow modulation is initiated and maintained during cardiopulmonary bypass unless clinically contraindicated. The perfusionist has real-time access to cerebral autoregulation monitoring data. When predefined algorithm-based criteria for impaired cerebral autoregulation are detected, a visual event is generated. Blood pressure management decisions are made by the perfusionist based on cerebral autoregulation status and standard clinical practice.
Standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. Adjunctive cerebral oxygenation monitoring using near-infrared spectroscopy (NIRS) may be used if routinely applied at the site.