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

NCT07000461 | Recruiting

• 1 other identifier: 2025/102
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Cognitive Dysfunction; Delirium, Postoperative

Keywords

transcranial doppler; delirium; POCD; cerebral perfusion; CABG

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Postoperative day 5

Secondary Outcomes (4)

• Acute kidney injury stage (KDIGO)

  Postoperative 24th hour

• Duration of mechanical ventilation

  Postoperative 24th hour

• Length of stay in intensive care

  within 30 days after surgery

• Length of hospital stay

  within 60 days after surgery

Study Arms (2)

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

Transcranial Doppler measurement of the middle cerebral artery PROCEDURE

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.

Group Non Pulsatile Perfusion; Group Pulsatile perfusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for isolated elective cardiopulmonary bypass surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Sema Nur Baki, M.D

CONTACT

+905069443789; sema.akcelik@gmail.com

Dicle Birtane, M.D, FCCM

CONTACT

+905545460396; dicle1tane@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: June 3, 2025
• Study Start: April 17, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (1)