Postoperative Cognitive DysfunctionNCT07000461
Transcranial Doppler as a Predictor of Postoperative Cognitive Dysfunction Following Cardiopulmonary Bypass
An observational study of Postoperative Cognitive Dysfunction and Delirium, Postoperative, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neurological dysfunction either transient or permanent is a major cause of morbidity and mortality after cardiopulmonary bypass, and cognitive dysfunction is more frequent in cardiac surgery than in non-cardiac procedures. Variations in cerebral blood flow and oxygen extraction are considered key contributing factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Delirium, Postoperative
- What is being tested?
- Transcranial Doppler measurement of the middle cerebral artery
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2025to 30 Apr 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for isolated elective cardiopulmonary bypass surgery
Who may be able to join
- Patients aged 18-70
- Patients scheduled for isolated elective cardiopulmonary bypass surgery
Who cannot join
- Patients with carotid stenosis ≥50%
- Emergency patients or those with a history of reoperation
- Patients with a history of cerebrovascular events
- Patients who do not provide consent
- Patients with temporal window failure
- Patients with an ejection fraction (EF) <40%
- Patients with a Mini-Mental State Examination (MMSE) score <23
- Patients who require mechanical ventilation for more than 24 hours or those who are reintubated
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul
About this study
Official title: Can Transcranial Doppler Predict Postoperative Cognitive Dysfunction After Cardiopulmonary Bypass
Neurological dysfunction either transient or permanent is a major cause of morbidity and mortality after cardiopulmonary bypass, and cognitive dysfunction is more frequent in cardiac surgery than in non-cardiac procedures. Variations in cerebral blood flow and oxygen extraction are considered key contributing factors. Although pulsatile flow during bypass has shown benefits for renal function and recovery, its effects on postoperative neurological dysfunction and delirium remain unclear due to limited research. This study aims to evaluate the impact of pulsatile versus non-pulsatile cardiopulmonary bypass flow on POCD in adult CABG patients by measuring middle cerebral artery (MCA) flow using transcranial Doppler.
Read the detailed description
Patient Selection:
Our study is a single-center, prospective, observational study. The study will include 65 patients scheduled for elective coronary artery bypass grafting (CABG) surgery between 01.04.2025 and 31.03.2026 at the Health Sciences University, Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patients aged 18-70, and those scheduled for isolated elective coronary artery bypass grafting, will be included. Patients with carotid stenosis greater than 50%, a history of cerebrovascular events, those who do not provide consent, those with temporal window failure, ejection fraction (EF) below 40%, a preoperative Mini-Mental State Examination (MMSE) score under 23, those requiring mechanical ventilation for more than 24 hours, or those requiring reintubation will be excluded from the study.
Preoperative Preparation:
Patients eligible for the study will be informed about the study, and a voluntary consent form will be obtained. The demographic characteristics of the patients (age, gender, comorbidities, ASA score, BMI, ejection fraction, kidney function tests, EUROSCORE 2 score) will be recorded. All patients will undergo the Mini-Mental State Examination (MMSE) 24 hours before the operation. All patients will undergo standard cardiovascular surgical monitoring (electrocardiography (ECG), non-invasive blood pressure monitoring, peripheral oxygen saturation (SpO2), bilateral regional cerebral oxygen saturation (rSO2) measured by near-infrared spectroscopy (NIRS), and processed EEG monitoring). At the beginning of anesthesia, two 18-20 G granule peripheral venous access lines will be established. The decision regarding whether to use pulsatile or non-pulsatile pump flow will be made by the surgical team. The preoperative baseline (T1) middle cerebral artery (MCA) flow value will be measured using transcranial Doppler with a low-frequency (2-3.5 MHz) sector/cardiac probe. The trans-temporal window, one of the acoustic windows of the skull, will be identified anatomically by locating the hyperechoic image of the sphenoid and temporal bone petrous part between the upper zygomatic arch, external auditory canal, and orbit. In the color Doppler mode of ultrasound, MCA flow will be observed at a depth of 3-7 cm with the probe approaching, and pulse wave (PW) Doppler will be applied. Peak systolic and end-diastolic measurements will be recorded as the average of the three values shown on the screen and documented. Invasive arterial monitoring will be routinely performed.
Perioperative Process:
During anesthesia induction, patients will receive 0.1-0.2 mg/kg of midazolam, 5-8 µg/kg of fentanyl, and 0.6 mg/kg of rocuronium. Anesthesia depth will be maintained with sevoflurane inhalation, dexmedetomidine, and remifentanil infusion, with a Patient State Index (PSI) general anesthesia level maintained between 25-50. After anesthesia induction (T2), after cross-clamping at the 10th minute (T3), 20th minute (T4), 30th minute (T5), after the cross-clamp is removed (T6), and at the end of surgery (T7), transcranial Doppler measurements, mean arterial pressure (MAP), and cerebral oxygen saturation (rSO2) values will be recorded. Arterial blood gas analyses will be recorded at T2, T3, T6, and T7.
Postoperative Process :
The patient will be admitted to the Postoperative Cardiovascular Surgery Intensive Care Unit. At 24 hours postoperatively, delirium will be assessed using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) in the intensive care unit. For patients with prolonged ICU stays, delirium assessments using CAM-ICU will continue. On the 2nd-4th days, delirium evaluation will be conducted in the morning and evening using the 3DCAM test in the service setting. At 24 hours, ventilator time, fluid balance, urine output, inotropic/vasopressor requirements, presence of new arrhythmias, amount of blood products used postoperatively, kidney function tests (AKI), and other recorded data will be evaluated. A repeat Mini-Mental State Examination (MMSE) will be performed on the 5th day of the hospital stay. Cerebrovascular events during the hospital stay will also be recorded.
- Being tested
- Transcranial Doppler measurement of the middle cerebral artery
- Keywords
- transcranial doppler, delirium, POCD, cerebral perfusion, CABG
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler measurement of the middle cerebral arteryProcedure or surgery
Transcranial Doppler examination was performed using a low-frequency (2-3.5 MHz) sector/cardiac probe through the transtemporal acoustic window. Middle cerebral artery (MCA) flow was identified in color Doppler mode at a depth of 3-7 cm with flow directed toward the probe. Pulsed-wave Doppler was applied, and peak systolic and end-diastolic velocities were recorded as the average of three measurements.
| Study group | Role | What they receive |
|---|---|---|
| Group Pulsatile perfusion | Pulsatile group in pump blood flow After cross-clamping, pulsatile pump flow will be established. The flow will be continued until the cross-clamp is released. Receives: Procedure: Transcranial Doppler measurement of the middle cerebral artery | |
| Group Non Pulsatile Perfusion | Non Pulsatile group in pump blood flow After cross-clamping, non pulsatile pump flow will be established. The flow will be continued until the cross-clamp is released. Receives: Procedure: Transcranial Doppler measurement of the middle cerebral artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle cerebral artery mean flow velocity measured by transcranial Doppler
Perioperative transcranial Doppler will be used to measure middle cerebral artery mean flow velocity at predefined time points: before anesthesia induction, after anesthesia induction, at the 10th, 20th, and 30th minutes after aortic cross-clamping, and after removal of the aortic cross-clamp, end of the surgery.
Measured: Perioperative period
Postoperative delirium incidence (yes/no)
Postoperative delirium will be assessed as present or absent based on delirium screening (CAM-ICU in ICU; 3D-CAM on the ward) performed twice daily during postoperative days 1-5. Delirium is defined as at least one positive screen.
Measured: Postoperative days 1-5
Postoperative cognitive dysfunction (MMSE score change)
The outcome is the change in MMSE score from the preoperative baseline assessment to postoperative day 5.
Measured: Postoperative day 5
Secondary outcomes (4)
Acute kidney injury stage (KDIGO)
Acute kidney injury will be defined and staged according to KDIGO criteria (stages 0-3) based on postoperative changes in serum creatinine and/or urine output
Measured: Postoperative 24th hour
Duration of mechanical ventilation
The duration of ventilator support withdrawal in the postoperative intensive care unit
Measured: Postoperative 24th hour
Length of stay in intensive care
The time the patient is transferred from intensive care to the ward
Measured: within 30 days after surgery
Length of hospital stay
The time the patient is discharged home
Measured: within 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start17 Apr 2025
- Primary completion31 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000461
- Sponsor's protocol ID
- 2025/102
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcranial Doppler Predict Postoperative Cognitive Dysfunction After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07000461
- Acronym / sponsor ID
- 2025/102
- Keywords
- transcranial doppler, delirium, POCD, cerebral perfusion, CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Jun 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.
Neurological dysfunction either transient or permanent is a major cause of morbidity and mortality after cardiopulmonary bypass, and cognitive dysfunction is more frequent in cardiac surgery than in non-cardiac procedures. Variations in cerebral blood flow and oxygen extraction are considered key contributing factors. Although pulsatile flow during bypass has shown benefits for renal function and recovery, its effects on postoperative neurological dysfunction and delirium remain unclear due to limited research. This study aims to evaluate the impact of pulsatile versus non-pulsatile cardiopulmonary bypass flow on POCD in adult CABG patients by measuring middle cerebral artery (MCA) flow using transcranial Doppler.
Detailed description
Patient Selection:
Our study is a single-center, prospective, observational study. The study will include 65 patients scheduled for elective coronary artery bypass grafting (CABG) surgery between 01.04.2025 and 31.03.2026 at the Health Sciences University, Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patients aged 18-70, and those scheduled for isolated elective coronary artery bypass grafting, will be included. Patients with carotid stenosis greater than 50%, a history of cerebrovascular events, those who do not provide consent, those with temporal window failure, ejection fraction (EF) below 40%, a preoperative Mini-Mental State Examination (MMSE) score under 23, those requiring mechanical ventilation for more than 24 hours, or those requiring reintubation will be excluded from the study.
Preoperative Preparation:
Patients eligible for the study will be informed about the study, and a voluntary consent form will be obtained. The demographic characteristics of the patients (age, gender, comorbidities, ASA score, BMI, ejection fraction, kidney function tests, EUROSCORE 2 score) will be recorded. All patients will undergo the Mini-Mental State Examination (MMSE) 24 hours before the operation. All patients will undergo standard cardiovascular surgical monitoring (electrocardiography (ECG), non-invasive blood pressure monitoring, peripheral oxygen saturation (SpO2), bilateral regional cerebral oxygen saturation (rSO2) measured by near-infrared spectroscopy (NIRS), and processed EEG monitoring). At the beginning of anesthesia, two 18-20 G granule peripheral venous access lines will be established. The decision regarding whether to use pulsatile or non-pulsatile pump flow will be made by the surgical team. The preoperative baseline (T1) middle cerebral artery (MCA) flow value will be measured using transcranial Doppler with a low-frequency (2-3.5 MHz) sector/cardiac probe. The trans-temporal window, one of the acoustic windows of the skull, will be identified anatomically by locating the hyperechoic image of the sphenoid and temporal bone petrous part between the upper zygomatic arch, external auditory canal, and orbit. In the color Doppler mode of ultrasound, MCA flow will be observed at a depth of 3-7 cm with the probe approaching, and pulse wave (PW) Doppler will be applied. Peak systolic and end-diastolic measurements will be recorded as the average of the three values shown on the screen and documented. Invasive arterial monitoring will be routinely performed.
Perioperative Process:
During anesthesia induction, patients will receive 0.1-0.2 mg/kg of midazolam, 5-8 µg/kg of fentanyl, and 0.6 mg/kg of rocuronium. Anesthesia depth will be maintained with sevoflurane inhalation, dexmedetomidine, and remifentanil infusion, with a Patient State Index (PSI) general anesthesia level maintained between 25-50. After anesthesia induction (T2), after cross-clamping at the 10th minute (T3), 20th minute (T4), 30th minute (T5), after the cross-clamp is removed (T6), and at the end of surgery (T7), transcranial Doppler measurements, mean arterial pressure (MAP), and cerebral oxygen saturation (rSO2) values will be recorded. Arterial blood gas analyses will be recorded at T2, T3, T6, and T7.
Postoperative Process :
The patient will be admitted to the Postoperative Cardiovascular Surgery Intensive Care Unit. At 24 hours postoperatively, delirium will be assessed using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) in the intensive care unit. For patients with prolonged ICU stays, delirium assessments using CAM-ICU will continue. On the 2nd-4th days, delirium evaluation will be conducted in the morning and evening using the 3DCAM test in the service setting. At 24 hours, ventilator time, fluid balance, urine output, inotropic/vasopressor requirements, presence of new arrhythmias, amount of blood products used postoperatively, kidney function tests (AKI), and other recorded data will be evaluated. A repeat Mini-Mental State Examination (MMSE) will be performed on the 5th day of the hospital stay. Cerebrovascular events during the hospital stay will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Pulsatile perfusion | – | Procedure: Transcranial Doppler measurement of the middle cerebral arteryPulsatile group in pump blood flow After cross-clamping, pulsatile pump flow will be established. The flow will be continued until the cross-clamp is released. |
| Group Non Pulsatile Perfusion | – | Procedure: Transcranial Doppler measurement of the middle cerebral arteryNon Pulsatile group in pump blood flow After cross-clamping, non pulsatile pump flow will be established. The flow will be continued until the cross-clamp is released. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for isolated elective cardiopulmonary bypass surgery
Key inclusion criteria (2 listed)
- Patients aged 18-70
- Patients scheduled for isolated elective cardiopulmonary bypass surgery
Key exclusion criteria (8 listed)
- Patients with carotid stenosis ≥50%
- Emergency patients or those with a history of reoperation
- Patients with a history of cerebrovascular events
- Patients who do not provide consent
- Patients with temporal window failure
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 |
|---|---|---|
| Transcranial Doppler measurement of the middle cerebral arteryTranscranial Doppler examination was performed using a low-frequency (2-3.5 MHz) sector/cardiac probe through the transtemporal acoustic window. Middle cerebral artery (MCA) flow was identified in color Doppler mode at a depth of 3-7 cm with flow directed toward the probe. Pulsed-wave Doppler was applied, and peak systolic and end-diastolic velocities were recorded as the average of three measurements. | Procedure or surgery | Group Non Pulsatile Perfusion, Group Pulsatile perfusion |
Primary outcome
Middle cerebral artery mean flow velocity measured by transcranial Doppler
Time frame: Perioperative period
Perioperative transcranial Doppler will be used to measure middle cerebral artery mean flow velocity at predefined time points: before anesthesia induction, after anesthesia induction, at the 10th, 20th, and 30th minutes after aortic cross-clamping, and after removal of the aortic cross-clamp, end of the surgery.
Postoperative delirium incidence (yes/no)
Time frame: Postoperative days 1-5
Postoperative delirium will be assessed as present or absent based on delirium screening (CAM-ICU in ICU; 3D-CAM on the ward) performed twice daily during postoperative days 1-5. Delirium is defined as at least one positive screen.
Postoperative cognitive dysfunction (MMSE score change)
Time frame: Postoperative day 5
The outcome is the change in MMSE score from the preoperative baseline assessment to postoperative day 5.
4 secondary outcomes
Acute kidney injury stage (KDIGO)
Time frame: Postoperative 24th hour
Duration of mechanical ventilation
Time frame: Postoperative 24th hour
Length of stay in intensive care
Time frame: within 30 days after surgery
Length of hospital stay
Time frame: within 60 days after surgery
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 20 Oct 2026.
- 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 Postoperative Cognitive Dysfunction and Delirium, Postoperative, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 2 inclusion and 8 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 20 Oct 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?
Middle cerebral artery mean flow velocity measured by transcranial Doppler (time frame: Perioperative period). The study lists 3 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 20 Oct 2026.