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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ONSD change from baseline (T0 to T6)
Timeframe: Measured by ultrasound at 7 time points intraoperative time period
2
30-day stroke incidence
Timeframe: postoperative 30 days
Trial details
NCT IDNCT07661238
SponsorBursa Yuksek Ihtisas Training and Research Hospital