ClinicalTrials.gg
CompletedNCT07000461Updated Oct 20, 2026

Transcranial Doppler as a Predictor of Postoperative Cognitive Dysfunction Following Cardiopulmonary Bypass

An observational study in Postoperative Cognitive Dysfunction and Delirium, Postoperative, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

Updated Oct 20, 2026Now CompletedEnrollment updatedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 32 studies in Postoperative Cognitive Complications with a site in Turkey — 6 open to participants now, 8 under way, none of them phase 3. Postoperative Cognitive Complications · Turkey.

Enrollment
6th of 19
110 · median 80
Started
2025
with 6 others
Observational
19 of 32
4 open now
Registered
18th of 32
by date
Lead sponsor
1 of 32
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Among the 32 studies in Postoperative Cognitive Complications with a site in Turkey, this one is the 6th largest by enrollment of the 19 observational ones that give a count, is one of 7 that started in 2025, is one of 19 observational ones, and was the 18th registered.

Postoperative Cognitive Complications

260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.

Browse Postoperative Cognitive Complications studies →

Open to participants now

6 of the 32 studies in Postoperative Cognitive Complications with a site in Turkey are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 34 Postoperative Cognitive Complications studies recruiting now, 22 (65%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Postoperative Cognitive Dysfunction
  • Delirium, Postoperative

Keywords

  • transcranial doppler
  • delirium
  • POCD
  • cerebral perfusion
  • CABG
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled for isolated elective cardiopulmonary bypass surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-70
  • Patients scheduled for isolated elective cardiopulmonary bypass surgery

Exclusion criteria

Exclusion Criteria:

  • 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 (EF) \<40%
  • Patients with a (MMSE) score \<23
  • Patients who require mechanical ventilation for more than 24 hours or those who are reintubated
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Procedure: Transcranial Doppler measurement of the middle cerebral artery

Interventions

  • ProcedureTranscranial Doppler measurement of the middle cerebral artery

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Perioperative period

  2. 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.

    Time frame: Postoperative days 1-5

  3. Postoperative cognitive dysfunction (MMSE score change)

    The outcome is the change in MMSE score from the preoperative baseline assessment to postoperative day 5.

    Time frame: Postoperative day 5

Secondary outcomes

  1. 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

    Time frame: Postoperative 24th hour

  2. Duration of mechanical ventilation

    The duration of ventilator support withdrawal in the postoperative intensive care unit

    Time frame: Postoperative 24th hour

  3. Length of stay in intensive care

    The time the patient is transferred from intensive care to the ward

    Time frame: within 30 days after surgery

  4. Length of hospital stay

    The time the patient is discharged home

    Time frame: within 60 days after surgery

07

Study locations

1 site
  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Mar 2026, 11 months.

Of 76 non-industry observational studies under Postoperative Cognitive Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's 11 months is below that.

Counting every sponsor, half of 76 studies reached it within 27 months; a quarter within 11 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2025
First posted
Jun 3, 2025
StartActual
Apr 17, 2025
Primary completionActual
Mar 31, 2026
CompletionActual
Apr 30, 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 20, 2026
Enrollment
106 (estimated)→110 (actual)
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Completed
    Enrollment 106 (estimated)→110 (actual)
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07000461
Responsible party
Sponsor
First posted
Jun 3, 2025
Start date
Apr 17, 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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