Cognitive Dysfunction, PostoperativeNCT07361068
Assessment of Brain Oxygen Drops During Surgery and Related Risk Factors for Cognitive Problems After Heart Surgery
An observational study of Cognitive Dysfunction, Postoperative and Cognitive Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study examines whether decreases in brain oxygen levels during cardiac surgery are linked to postoperative cognitive dysfunction and identifies other factors that may increase the risk of cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Dysfunction, Postoperative, Cognitive Dysfunction, Cardiac Surgery
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 25 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia
Who may be able to join
- Planned elective CPB surgery
- Provision of written informed consent
- Absence of communication barriers that could interfere with preoperative and postoperative MMSE assessment
- No history of cerebrovascular disease
- Preoperative MMSE score ≥24
- Education level of at least high school
- Absence of any frontal deformity that could hinder NIRS monitoring
Who cannot join
- Preoperative use of antipsychotic or antidepressant medications
- Emergency cardiac surgery indication
- Presence of ≥50% carotid artery stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Traning and Research Hospital
Bursa, 16000
About this study
Official title: Evaluation of Intraoperative Cerebral Desaturation and Risk Factors Associated With Cognitive Dysfunction After Cardiac Surgery
This study examines whether decreases in brain oxygen levels during cardiac surgery are linked to postoperative cognitive dysfunction and identifies other factors that may increase the risk of cognitive impairment.
Read the detailed description
In this prospective study, the relationship between intraoperative cerebral oxygen saturation and postoperative cognitive dysfunction (POCD) was investigated in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB). Patients with a preoperative Mini-Mental State Examination (MMSE) score ≥ 24, no history of cerebrovascular disease, and no conditions that could interfere with near-infrared spectroscopy (NIRS) monitoring were included.
Measurements were recorded at the following time points: T0 (before induction), T1 (15 minutes after induction), T2 (5 minutes after initiation of CPB), T3 (during the hypothermic phase of CPB), T4 (rewarming phase of CPB, at 34 °C), T5 (termination of CPB), and T6 (upon admission to the intensive care unit). Patients were divided into two groups according to postoperative cognitive outcomes: those who developed POCD and those who did not.
Cognitive function was assessed using the MMSE preoperatively and on postoperative days 4, 7, and 30. During surgery, cerebral oxygen saturation was measured at predefined time points using NIRS probes placed on the frontal region, and detailed intraoperative and perioperative data were recorded. Standardized interventions were implemented when a decrease of more than 20% in regional cerebral oxygen saturation (rSO₂) from baseline was detected in order to maintain adequate cerebral oxygenation.
- Keywords
- Cognitive dysfunction, Near infrared spectroscopy, cardiopulmonary bypass
- Medical subject headings
- Postoperative Cognitive Complications, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group POCD: Patients develop cognitive dysfunction after cardiac surgery | The POCD group (n=24) comprised patients undergoing elective cardiac surgery with cardiopulmonary bypass who developed postoperative cognitive dysfunction, defined as an MMSE score ≤23 at any postoperative assessment. ( Postoperative day 4 ,7, 30) | |
| Group non-POCD : Patients did not develop postoperative cognitive dysfunction | The non-POCD group (n = 50) consisted of adult patients undergoing elective cardiac surgery with cardiopulmonary bypass whose MMSE scores remained ≥24 at all postoperative assessments, indicating no postoperative cognitive dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Cognitive Dysfunction (POCD)
Postoperative cognitive dysfunction (POCD) is defined as a decline in cognitive performance assessed using the Mini-Mental State Examination (MMSE), with a score of ≤23 at any postoperative assessment compared with a preoperative baseline MMSE score of ≥24. This primary outcome evaluates the association between intraoperative cerebral oxygen desaturation, measured by near-infrared spectroscopy (NIRS) as a reduction of >20% from baseline regional cerebral oxygen saturation (rSO₂), and postoperative cognitive dysfunction following cardiac surgery with cardiopulmonary bypass.
Measured: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.
Secondary outcomes (9)
Intraoperative Cerebral Oxygen Desaturation Measured by NIRS
Magnitude of intraoperative decreases in regional cerebral oxygen saturation (rSO₂) relative to baseline, measured using near-infrared spectroscopy (NIRS) at predefined intraoperative time points.
Measurements are recorded at:
T0: before induction of anesthesia T1: 15 minutes after induction of anesthesia T2: 5 minutes after initiation of cardiopulmonary bypass (CPB) T3: hypothermic phase of CPB T4: rewarming phase of CPB (34 °C) T5: weaning from CPB T6: upon admission to the intensive care unit (ICU)
Measured: Perioperatively (during surgery) through immediate postoperative period (upon ICU admission).
Postoperative Cognitive Performance Over Time Assessed by MMSE
Changes in cognitive performance over time assessed using the Mini-Mental State Examination (MMSE) to evaluate early and late postoperative cognitive recovery.
Measured: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.
Operation Time
Operation time will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Measure : Minute
Measured: From skin incision to skin closure during surgery
Cardiopulmonary Bypass (CPB) Duration
Cardiopulmonary bypass duration will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Measure : Minute
Measured: From initiation to termination of cardiopulmonary bypass during surgery (single intraoperative assessment).
Aortic Cross-Clamp (ACC) Duration
Aortic cross-clamp duration will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Meusure: Minute
Measured: From application to removal of the aortic cross-clamp during surgery (single intraoperative assessment)
Time to Extubation
Time to extubation will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Measure: Hour
Measured: From completion of surgery until successful extubation, assessed up to 30 postoperative days
Intensive Care Unit Length of Stay
Length of intensive care unit stay will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Measure: Hour
Measured: From ICU admission after surgery until ICU discharge, assessed up to 30 postoperative days.
Hospital Length of Stay
Hospital length of stay will be compared between patients with and without postoperative cognitive dysfunction (POCD).
Measure: Day
Measured: From hospital admission for cardiac surgery until hospital discharge, assessed up to 30 postoperative days.
Correlation Between Perioperative Clinical Variables and Postoperative MMSE Scores
Correlation between perioperative clinical variables and postoperative cognitive performance assessed using the Mini-Mental State Examination (MMSE). Variables correlated with MMSE scores include: Operation time (minutes) Cardiopulmonary bypass (CPB) duration (minutes) Aortic cross-clamp (ACC) duration (minutes) Intensive care unit (ICU) length of stay (hours) Hospital length of stay (days)
Measured: Postoperative day 4, postoperative day 7, and postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Dysfunction, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ŞULE BALK, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361068
- Sponsor's protocol ID
- 011-KAEK-25 2023/02-15
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu YN, Hsieh TH, Tsai MT, Chien CY, Roan JN, Huang YC, Liang SF. Cognitive Function Deterioration After Cardiopulmonary Bypass: Can Intraoperative Optimal Cerebral Regional Tissue Oxygen Saturation Predict Postoperative Cognitive Function? J Cardiothorac Vasc Anesth. 2023 May;37(5):715-723. doi: 10.1053/j.jvca.2023.01.025. Epub 2023 Feb 2.
PubMed 36813631Lewis C, Parulkar SD, Bebawy J, Sherwani S, Hogue CW. Cerebral Neuromonitoring During Cardiac Surgery: A Critical Appraisal With an Emphasis on Near-Infrared Spectroscopy. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2313-2322. doi: 10.1053/j.jvca.2018.03.032. Epub 2018 Mar 20.
PubMed 30100271
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Cerebral Desaturation and Risk Factors Associated With Cognitive Dysfunction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07361068
- Acronym / sponsor ID
- 011-KAEK-25 2023/02-15
- Keywords
- Cognitive dysfunction, Near infrared spectroscopy, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 22 Jan 2026 (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.
This study examines whether decreases in brain oxygen levels during cardiac surgery are linked to postoperative cognitive dysfunction and identifies other factors that may increase the risk of cognitive impairment.
Detailed description
In this prospective study, the relationship between intraoperative cerebral oxygen saturation and postoperative cognitive dysfunction (POCD) was investigated in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB). Patients with a preoperative Mini-Mental State Examination (MMSE) score ≥ 24, no history of cerebrovascular disease, and no conditions that could interfere with near-infrared spectroscopy (NIRS) monitoring were included.
Measurements were recorded at the following time points: T0 (before induction), T1 (15 minutes after induction), T2 (5 minutes after initiation of CPB), T3 (during the hypothermic phase of CPB), T4 (rewarming phase of CPB, at 34 °C), T5 (termination of CPB), and T6 (upon admission to the intensive care unit). Patients were divided into two groups according to postoperative cognitive outcomes: those who developed POCD and those who did not.
Cognitive function was assessed using the MMSE preoperatively and on postoperative days 4, 7, and 30. During surgery, cerebral oxygen saturation was measured at predefined time points using NIRS probes placed on the frontal region, and detailed intraoperative and perioperative data were recorded. Standardized interventions were implemented when a decrease of more than 20% in regional cerebral oxygen saturation (rSO₂) from baseline was detected in order to maintain adequate cerebral oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group POCD: Patients develop cognitive dysfunction after cardiac surgery | – | –The POCD group (n=24) comprised patients undergoing elective cardiac surgery with cardiopulmonary bypass who developed postoperative cognitive dysfunction, defined as an MMSE score ≤23 at any postoperative assessment. ( Postoperative day 4 ,7, 30) |
| Group non-POCD : Patients did not develop postoperative cognitive dysfunction | – | –The non-POCD group (n = 50) consisted of adult patients undergoing elective cardiac surgery with cardiopulmonary bypass whose MMSE scores remained ≥24 at all postoperative assessments, indicating no postoperative cognitive dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia
Key inclusion criteria (7 listed)
- Planned elective CPB surgery
- Provision of written informed consent
- Absence of communication barriers that could interfere with preoperative and postoperative MMSE assessment
- No history of cerebrovascular disease
- Preoperative MMSE score ≥24
Key exclusion criteria (3 listed)
- Preoperative use of antipsychotic or antidepressant medications
- Emergency cardiac surgery indication
- Presence of ≥50% carotid artery stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Cognitive Dysfunction (POCD)
Time frame: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.
Postoperative cognitive dysfunction (POCD) is defined as a decline in cognitive performance assessed using the Mini-Mental State Examination (MMSE), with a score of ≤23 at any postoperative assessment compared with a preoperative baseline MMSE score of ≥24. This primary outcome evaluates the association between intraoperative cerebral oxygen desaturation, measured by near-infrared spectroscopy (NIRS) as a reduction of >20% from baseline regional cerebral oxygen saturation (rSO₂), and postoperative cognitive dysfunction following cardiac surgery with cardiopulmonary bypass.
9 secondary outcomes
Intraoperative Cerebral Oxygen Desaturation Measured by NIRS
Time frame: Perioperatively (during surgery) through immediate postoperative period (upon ICU admission).
Postoperative Cognitive Performance Over Time Assessed by MMSE
Time frame: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.
Operation Time
Time frame: From skin incision to skin closure during surgery
Cardiopulmonary Bypass (CPB) Duration
Time frame: From initiation to termination of cardiopulmonary bypass during surgery (single intraoperative assessment).
Aortic Cross-Clamp (ACC) Duration
Time frame: From application to removal of the aortic cross-clamp during surgery (single intraoperative assessment)
Time to Extubation
Time frame: From completion of surgery until successful extubation, assessed up to 30 postoperative days
Intensive Care Unit Length of Stay
Time frame: From ICU admission after surgery until ICU discharge, assessed up to 30 postoperative days.
Hospital Length of Stay
Time frame: From hospital admission for cardiac surgery until hospital discharge, assessed up to 30 postoperative days.
Correlation Between Perioperative Clinical Variables and Postoperative MMSE Scores
Time frame: Postoperative day 4, postoperative day 7, and postoperative day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 36813631Hu YN, Hsieh TH, Tsai MT, Chien CY, Roan JN, Huang YC, Liang SF. Cognitive Function Deterioration After Cardiopulmonary Bypass: Can Intraoperative Optimal Cerebral Regional Tissue Oxygen Saturation Predict Postoperative Cognitive Function? J Cardiothorac Vasc Anesth. 2023 May;37(5):715-723. doi: 10.1053/j.jvca.2023.01.025. Epub 2023 Feb 2.
- Results publication: PubMed 30100271Lewis C, Parulkar SD, Bebawy J, Sherwani S, Hogue CW. Cerebral Neuromonitoring During Cardiac Surgery: A Critical Appraisal With an Emphasis on Near-Infrared Spectroscopy. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2313-2322. doi: 10.1053/j.jvca.2018.03.032. Epub 2018 Mar 20.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, Postoperative and Cognitive Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Cognitive Dysfunction (POCD) (time frame: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07361068, which also lists 2 linked publications.
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 27 Jan 2026.