Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery

NCT07420738 | Not Yet Recruiting

• 1 other identifier: 2026/76/1314
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study aims to compare the effects of minimal invasive extracorporeal circulation (MiECC) and conventional reservoir-based extracorporeal circulation techniques on cerebral perfusion in patients undergoing elective coronary artery bypass graft (CABG) surgery. Although the adverse effects of cardiopulmonary bypass on cerebral perfusion and oxygenation are well recognized, the relationship between these effects and changes in intracranial pressure has not been fully elucidated. In this context, ultrasonographic measurement of optic nerve sheath diameter (ONSD), a non-invasive surrogate marker of intracranial pressure, will be used in combination with near-infrared spectroscopy (NIRS) to enable a comprehensive assessment of cerebral perfusion and oxygenation. Between February 2026 and February 2027, a total of 70 ASA II-III patients scheduled for elective CABG surgery will be prospectively enrolled and allocated according to the extracorporeal circulation technique used. Perioperative ONSD measurements will be performed by a single anesthesiologist blinded to the perfusion technique. The primary endpoint is the comparison of perioperative changes in ONSD between the two techniques. Secondary endpoints include the correlation between ONSD and NIRS values, incidence of cerebrovascular events, extubation time, duration of intensive care unit and hospital stay, perioperative hemodynamic parameters, and postoperative complications. This study is expected to provide clinically relevant data on the cerebral effects of different extracorporeal circulation strategies and contribute to perioperative neuromonitoring practices in cardiac surgery.

Conditions

Intracranial Hypertension

Keywords

İntracranial pressure; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

• Perioperative Optic Nerve Sheath Diameter (ONSD)

  Perioperative changes in optic nerve sheath diameter will be measured using ultrasonography to evaluate the effects of different extracorporeal circulation techniques on intracranial pressure-related cerebral perfusion.

  Before initiation of cardiopulmonary bypass (CPB), during CPB, and immediately after completion of CPB (within the intraoperative period).

Secondary Outcomes (6)

• Cerebral Oxygenation (NIRS)

  From before induction of anesthesia through the intraoperative period until completion of anesthesia.

• Correlation Between ONSD and NIRS

  Correlation analysis performed using intraoperative ONSD and NIRS measurements obtained before CPB, during CPB, and after CPB within the intraoperative period

• Incidence of Cerebrovascular Events

  From completion of surgery to the occurrence of a postoperative cerebrovascular event or hospital discharge, whichever occurred first, assessed up to 30 postoperative days

• Extubation Time

  From completion of surgery to successful tracheal extubation in the intensive care unit, assessed up to 30 postoperative days.

• Duration of Mechanical Ventilation

  From completion of surgery to successful tracheal extubation in the intensive care unit, assessed up to 30 postoperative days.

Study Arms (2)

Minimal Invasive Extracorporeal Circulation (MiECC) Group

Patients undergoing elective coronary artery bypass graft surgery using a minimal invasive extracorporeal circulation system. Cerebral perfusion will be assessed perioperatively using ultrasonographic optic nerve sheath diameter measurements and near-infrared spectroscopy monitoring.

Conventional Extracorporeal Circulation (cECC) Group

Patients undergoing elective coronary artery bypass graft surgery using a conventional reservoir-based extracorporeal circulation system. Perioperative cerebral perfusion will be evaluated using ultrasonographic optic nerve sheath diameter measurements and near-infrared spectroscopy monitoring.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older with American Society of Anesthesiologists (ASA) physical status II-III who are scheduled to undergo elective coronary artery bypass graft surgery with the use of extracorporeal circulation. All participants will be treated according to standard clinical practice in a tertiary cardiac surgery center and will provide written informed consent prior to enrollment.

You may qualify if:

• Age ≥ 18 years
• Scheduled for elective coronary artery bypass graft (CABG) surgery
• American Society of Anesthesiologists (ASA) physical status II-III
• Planned use of extracorporeal circulation during surgery
• Ability to provide written informed consent

You may not qualify if:

• Age \< 18 years
• ASA physical status other than II-III
• Emergency surgery
• Pregnancy
• History of neurological disease affecting consciousness or decision-making capacity
• History of psychiatric disease affecting decision-making capacity
• History of head trauma within the previous 24 hours
• Presence of carotid artery stenosis or significant carotid artery disease
• Coagulation disorders (INR \> 1.25, aPTT \> 35 s, or platelet count \< 100,000/μL)
• Reoperation (redo cardiac surgery)
• Congestive heart failure
• Chronic kidney failure
• Sepsis
• Hypoxia
• Ocular trauma

Sponsors & Collaborators

• Kartal Kosuyolu High Speciality Training and Research Hospital: lead

Study Sites (1)

Kosuyolu High Specialization Training and Research Hospital

Istanbul, 34870, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mustafa Burgaç

  mustafaburgac@outlook.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Burgaç, himself

CONTACT

0 538 984 8198; mustafaburgac@gmail.com

Mustafa Burgaç

CONTACT

05389848198; mustafaburgac@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physician

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)