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

Condition(s) studied

Investigational drug(s) / intervention(s)

BrainProtect System: 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: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Postoperative Delirium and/or Postoperative Cognitive Dysfunction (Composite Neurological Outcome) — Up to postoperative Day 7
  Number (percentage) of participants with a positive binary composite outcome of postoperative delirium (POD) and/or postoperative cognitive dysfunction (POCD). Individual assessments are used only to classify participants as composite-positive or composite-negative. Individual test scores are not reported in this outcome measure. POD: ≥1 positive Confusion Assessment Method for the ICU (CAM-ICU) assessment on postoperative Days 1-4 (Feature 1 acute onset/fluctuating course and Feature 2 inattention, plus Feature 3 altered consciousness or Feature 4 disorganized thinking). POCD: decline from preoperative baseline (1-2 days before surgery) to postoperative Days 4-7 in ≥2 of 4 tests: Mini-Mental State Examination (≥3-point decrease), Hopkins Verbal Learning Test-Revised (≥20% decrease), Digit Symbol Substitution Test (≥20% decrease), Schulte Table test (≥20% increase in completion time). A participant is composite-positive if POD and/or POCD is present.

Trial sites (4)