Bentall surgery is a major cardiac procedure involving replacement of the ascending aorta, aortic root, and aortic valve, typically requiring cardiopulmonary bypass (CPB) and sometimes deep hypothermic circulatory arrest (DHCA). Due to its complexity, it carries a significant risk of postoperative neurological complications including stroke and postoperative cognitive dysfunction (POCD).
This prospective observational study aims to evaluate the relationship between perioperative bilateral optic nerve sheath diameter (ONSD) measurements obtained by ultrasound and postoperative cognitive functions in patients undergoing elective Bentall surgery. ONSD is a non-invasive surrogate marker of intracranial pressure that can be measured at the bedside using ultrasound.
In addition to routine hemodynamic monitoring and cerebral oximetry (NIRS), bilateral ONSD will be measured at predefined intraoperative and postoperative time points. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) test preoperatively and postoperatively, and delirium will be evaluated using the CAM-ICU scale during ICU stay. The association between perioperative ONSD values and postoperative cognitive outcomes, extubation time, ICU stay, and neurological complications will be analyzed.
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 between 18 and 80 years
* Scheduled for elective Bentall procedure
* Requiring cardiopulmonary bypass (CPB)
* Willing to participate and able to provide informed consent
* Able to complete the MoCA cognitive assessment test
Exclusion Criteria:
* Age below 18 or above 80 years
* Emergency Bentall surgery
* Pre-existing diagnosed cognitive impairment or dementia
* History of prior stroke or neurological disease
* Significant carotid artery stenosis
* Inability to complete the MoCA test (language barrier, illiteracy, visual or hearing impairment)
* Refusal to participate or inability to provide informed consent
* Patients with known psychiatric disorders
* Reoperation (redo surgery)
* Patients with severe renal or hepatic failure
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
Relationship between perioperative bilateral ONSD measurements and postoperative cognitive function
Timeframe: Preoperative baseline to postoperative hospital discharge at 30 days
Trial details
NCT IDNCT07452367
SponsorBursa Yuksek Ihtisas Training and Research Hospital