Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery

NCT07661238 | Active Not Recruiting

• 1 other identifier: 2024-TBEK 2025/10-06
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled trial compares the effects of Minimally Invasive Extracorporeal Circulation (MiECC) versus conventional cardiopulmonary bypass (CPB) on optic nerve sheath diameter (ONSD) and postoperative stroke incidence in adult patients undergoing isolated open heart surgery. ONSD will be measured by ultrasound at 7 predefined time points (T0-T6). Primary outcomes include perioperative ONSD changes and 30-day stroke incidence. Secondary outcomes include TIA, delirium (CAM-ICU), MoCA scores, ICU and hospital stay, AKI, and transfusion requirements.

Conditions

Stroke; Cardiac Surgery; Cardiopulmonary Bypass

Keywords

Optic Nerve Sheath Diameter; Minimally Invasive Extracorporeal Circulation; Neurological Complications; Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• ONSD change from baseline (T0 to T6)

  Bilateral ONSD measured by ultrasound (7.5-10 MHz linear probe) at 3 mm posterior to the optic disc. Three measurements per eye, mean value recorded. Change assessed from preoperative baseline (T0) through postoperative hour 24 (T6).

  Measured by ultrasound at 7 time points intraoperative time period

• 30-day stroke incidence

  Stroke defined as focal or global neurological deficit lasting more than 24 hours, confirmed by neuroimaging (CT or MRI), and graded by NIHSS score.

  postoperative 30 days

Study Arms (2)

MiECC Group

Patients undergoing isolated open heart surgery using minimally invasive extracorporeal circulation (closed-circuit, no venous reservoir, heparin-coated tubing, minimal prime volume \~500-700 mL)

Conventional CPB Group

Patients undergoing isolated open heart surgery using conventional cardiopulmonary bypass (open cardiotomy reservoir, gravity drainage, prime volume \~1500-2000 mL)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

,elective 18-80 aged, coronary bypass surgery patients with pump convansionel and MIECC

You may qualify if:

• Age 18 to 80 years
• Scheduled for elective isolated open heart surgery
• Requires cardiopulmonary bypass
• Able to provide written informed consent
• Adequate ultrasonographic window for ONSD measurement

You may not qualify if:

• Emergency or salvage surgery
• Off-pump, revision, or combined cardiac surgery
• History of stroke or TIA within the last 6 months
• Pre-existing neurological deficit
• Bilateral optic nerve pathology
• History of ocular trauma or surgery
• Intracranial mass or hydrocephalus
• Requirement for deep hypothermic circulatory arrest
• Alcohol or substance dependency
• Left ventricular ejection fraction \<30%
• Renal or hepatic failure with risk of advanced encephalopathy
• Preoperative requirement for mechanical circulatory support
• Symptomatic or severe carotid artery stenosis (\>70%)
• Refusal to participate in the study

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tuğba T ONUR, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Aygül A GÜNEŞ, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 22, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)