Combined processed EEG (PSi) and near-infrared spectroscopy (NIRS) monitoring to prevent postoperative cognitive problems after heart surgery
Prospective Randomized Controlled Study on the Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.
This trial will test whether using both processed EEG (PSi) and near-infrared spectroscopy (NIRS) during cardiac surgery with cardiopulmonary bypass can reduce postoperative cognitive disorders in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brugmann University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07267416 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults (≥18 years) undergoing cardiac surgery with extracorporeal circulation (valve procedures or CABG) and uses intraoperative SedLine® processed EEG (PSi) together with cerebral NIRS monitoring. Eligible patients must have a preoperative MoCA ≥20 and ASA class II–IV, while those with prior stroke, suspected dementia, preoperative encephalopathy, dialysis-dependent renal failure, or oxygen-dependent chronic respiratory failure are excluded. The approach compares management guided by combined PSi+NIRS monitoring versus standard intraoperative care to see if targeting deep anesthesia and cerebral desaturation reduces rates of postoperative cognitive disorders, with a planned secondary analysis for patients aged 65 and older. Cognitive testing is performed before and after surgery to measure postoperative cognitive outcomes.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing elective or semi-emergency valve surgery or coronary artery bypass grafting with cardiopulmonary bypass, ASA II–IV, and a preoperative MoCA score of 20 or higher are the intended participants.
Not a fit: Patients with a history of stroke, diagnosed or suspected dementia, preoperative encephalopathy, dialysis-dependent renal failure, or oxygen-dependent chronic respiratory failure are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, combined PSi and NIRS monitoring could lower the frequency or severity of postoperative cognitive disorders and improve recovery after cardiac surgery.
How similar studies have performed: Previous trials of NIRS or processed EEG alone have shown mixed results for preventing postoperative cognitive decline, and evidence specifically on the combined PSi+NIRS approach is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective or relatively emergency surgery for valve surgery (pulmonary or tricuspid valves) or coronary artery bypass grafting (CABG) * Preoperative cognitive assessment MoCA ≥ 20 (during the preoperative consultation if applicable or on day 1) * ASA score II to IV Exclusion Criteria: * History of sequelae of stroke * Diagnosis or strong suspicion of dementia (according to DSM-V criteria). * Preoperative encephalopathy * Severe chronic renal failure requiring dialysis * Patients with chronic respiratory failure who are oxygen-dependent
Where this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Aimane MENIOUI, MD — CHU Brugmann
- Study coordinator: Aimane MENIOUI, MD
- Email: aimane.menioui@chu-brugmann.be
- Phone: 3224754103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.