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NCT Number: NCT07267416

Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.

Advances in cardiac medicine and anesthesia have made it possible to expand the indications for open heart surgery to increasingly older and more complex patients. This development is taking place in a demographic context where the aging of the world population has become a structural reality. However, postoperative neurocognitive complications, and in particular postoperative cognitive disorders (POCD), are not limited to the elderly. They can affect all adults, including younger adults, particularly in the presence of risk factors such as prolonged cardiopulmonary bypass, deep anesthesia, or episodes of intraoperative cerebral desaturation.

The PSi-NIRS study was designed with this broad perspective in mind. It will include all adult patients (≥18 years) eligible for cardiac surgery under extracorporeal circulation, with a secondary analysis dedicated to patients aged 65 years and older, a group in which POCD is more frequent, more long-lasting, and often has more serious consequences. This division will allow to assess the impact of cerebral monitoring both in the general adult population and within a well-defined geriatric subgroup.

The pathophysiological mechanisms involved in POCD are now better understood. On the one hand, insufficient cerebral oxygenation, even transient, can disrupt neuronal homeostasis for a prolonged period. On the other hand, excessively deep anesthesia, leading to periods of EEG suppression, is recognized as a risk marker for delirium and postoperative cognitive decline. These two dimensions - perfusion and cortical activity - constitute complementary targets for prevention.

Independently of each other, two tools available today - near-infrared spectroscopy (NIRS) and processed electroencephalography (PSi via SedLine®) - have shown their value in cardiac surgery. The use of NIRS to guide intraoperative adjustments has been associated with a reduction in neurological complications. Anesthetic guidance by EEG makes it possible to limit periods of suppression, linked to an increased risk of delirium and POCD. However, to date, no randomized study has evaluated the combined and coordinated use of these two modalities, with a predefined therapeutic algorithm allowing real-time clinical intervention based on critical thresholds.

The PSi-NIRS study is therefore part of a logic of scientific continuity, but takes a methodological step forward by testing for the first time an integrated and proactive approach to cerebral monitoring, applied to a surgical context with high neurological risk. It aims to verify whether this strategy can improve the postoperative cognitive trajectory of patients, in the short and medium term, by targeting the real points of intraoperative cerebral vulnerability.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS (Near Infrared Spectroscopy)

Device

Real-time measurement of regional cerebral oxygenation.

SedLine®

Device

The SedLine® Brain Function Monitoring device (Masimo Corporation, model RDS7A, CE certified) uses four forehead electrodes to record EEG activity. The Patient State Index (PSi), calculated in real time, is interpreted within a target range of 25 to 50 to ensure adequate general anesthesia. The device complies with international standards for electrical safety (IEC 60601) and hospital use.

Primary outcomes

  1. MoCA (Montreal Cognitive Assessment)

    Time frame: Baseline, pre-surgery

    Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

  2. MoCA (Montreal Cognitive Assessment)

    Time frame: 2 days post surgery

    Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

  3. MoCA (Montreal Cognitive Assessment)

    Time frame: 7 days post surgery

    Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

  4. MoCA (Montreal Cognitive Assessment)

    Time frame: 25 days post surgery

    Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

  5. MoCA (Montreal Cognitive Assessment)

    Time frame: 30 days post surgery

    Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

Secondary outcomes

  1. Postoperative length of stay

    Time frame: Immediately after the surgery

    Postoperative length of stay

  2. Cumulative duration of burst deletions (SedLine)

    Time frame: During the surgery

  3. Cumulative duration of NIRS desaturation episodes

    Time frame: During the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Aimane MENIOUI, MD

CONTACT

[email protected]

3224754103

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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