Postoperative Cognitive DisordersNCT07267416
Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.
A study testing NIRS (Near Infrared Spectroscopy) and SedLine® in people with Postoperative Cognitive Disorders, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Disorders
- What is being tested?
- NIRS (Near Infrared Spectroscopy) and SedLine®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Seyed Javad Bidgoli, MD, 003224772179, SEYEDJAVAD.BIDGOLI@chu-brugmann.be
About this study
Official title: Prospective Randomized Controlled Study on the 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.
Read more
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.
- Conditions
- Postoperative Cognitive Disorders
- Being tested
- NIRS (Near Infrared Spectroscopy), SedLine®
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring + NIRS | Experimental | Dual intraoperative cerebral monitoring, consisting of
* PSi (Patient State Index) via SedLine®, an indicator of anesthetic depth (normal values between 25 and 50),
* NIRS (Near Infrared Spectroscopy), real-time measurement of regional cerebral oxygenation, associated with a standardized therapeutic algorithm. Receives: Device: NIRS (Near Infrared Spectroscopy); Device: SedLine® |
| Standard monitoring | Active comparator | Intraoperative cerebral monitoring, consisting of PSi (Patient State Index) via SedLine®. Receives: Device: SedLine® |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA (Montreal Cognitive Assessment)
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.
Measured: Baseline, pre-surgery
MoCA (Montreal Cognitive Assessment)
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.
Measured: 2 days post surgery
MoCA (Montreal Cognitive Assessment)
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.
Measured: 7 days post surgery
MoCA (Montreal Cognitive Assessment)
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.
Measured: 25 days post surgery
MoCA (Montreal Cognitive Assessment)
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.
Measured: 30 days post surgery
Secondary outcomes (3)
Postoperative length of stay
Postoperative length of stay
Measured: Immediately after the surgery
Cumulative duration of burst deletions (SedLine)
Measured: During the surgery
Cumulative duration of NIRS desaturation episodes
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start13 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Aimane MENIOUI, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267416
- Sponsor's protocol ID
- PsiNIRS
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on the Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT07267416
- Acronym / sponsor ID
- PsiNIRS
- Conditions
- Postoperative Cognitive Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring + NIRS | Experimental | Device: NIRS (Near Infrared Spectroscopy), Device: SedLine®Dual intraoperative cerebral monitoring, consisting of * PSi (Patient State Index) via SedLine®, an indicator of anesthetic depth (normal values between 25 and 50), * NIRS (Near Infrared Spectroscopy), real-time measurement of regional cerebral oxygenation, associated with a standardized therapeutic algorithm. |
| Standard monitoring | Active comparator | Device: SedLine®Intraoperative cerebral monitoring, consisting of PSi (Patient State Index) via SedLine®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS (Near Infrared Spectroscopy)Real-time measurement of regional cerebral oxygenation. | Device | Standard monitoring + NIRS |
| SedLine®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. | Device | Standard monitoring, Standard monitoring + NIRS |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Postoperative length of stay
Time frame: Immediately after the surgery
Cumulative duration of burst deletions (SedLine)
Time frame: During the surgery
Cumulative duration of NIRS desaturation episodes
Time frame: During the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Cognitive Disorders
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Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients
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Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aimane MENIOUI, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS (Near Infrared Spectroscopy) and SedLine® in people with Postoperative Cognitive Disorders, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimane MENIOUI, MD (3224754103, aimane.menioui@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (Montreal Cognitive Assessment) (time frame: Baseline, pre-surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.