Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Combined processed EEG (PSi) and near-infrared spectroscopy (NIRS) monitoring to prevent postoperative cognitive problems after heart surgery

Official title: Prospective Randomized Controlled Study on the Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.

Run by Brugmann University Hospital · NCT07267416 · Data updated 2026-11-12

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.

More Postoperative Cognitive Dysfunction trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorBrugmann University Hospital
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedMay 13, 2025
Main results expectedMay 15, 2026
Study endsMay 15, 2026
Registry record updatedDecember 5, 2025
Trial IDNCT07267416 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU Brugmann
    Brussels, Belgium
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.