Optic nerve ultrasound to track brain pressure and thinking after Bentall surgery
Official title: Evaluation of the Relationship Between Bilateral Optic Nerve Sheath Diameter (ONSD) Measurements and Postoperative Cognitive Functions in Bentall Surgeries: A Prospective Observational Study
Run by Bursa Yuksek Ihtisas Training and Research Hospital · NCT07452367 · Data updated 2026-11-12
This project will test whether bedside ultrasound measurements of the optic nerve sheath before, during, and after elective Bentall surgery can help predict changes in thinking and memory in adult patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bursa Yuksek Ihtisas Training and Research Hospital Government |
| Locations | 1 site (Bursa, Yıldırım) |
| Status | Recruiting |
| Started | August 30, 2025 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07452367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 scheduled for elective Bentall surgery requiring cardiopulmonary bypass who can provide informed consent and complete the Montreal Cognitive Assessment are ideal candidates.
✕Probably not a fit
Patients with preexisting diagnosed dementia or stroke, significant carotid stenosis, emergency or redo surgery, severe sensory or language barriers preventing MoCA completion, or severe renal/hepatic failure are unlikely to benefit from this diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling adults aged 18–80 who undergo elective Bentall procedures with cardiopulmonary bypass. Bilateral optic nerve sheath diameter (ONSD) will be measured by bedside ultrasound at predefined intraoperative and postoperative time points alongside routine hemodynamic monitoring and cerebral oximetry (NIRS). Cognitive function will be measured with the Montreal Cognitive Assessment before surgery and at specified postoperative timepoints to identify postoperative cognitive dysfunction. The study will analyze whether perioperative changes in ONSD correlate with postoperative cognitive outcomes.
Why it matters
Potential benefit: If successful, this could provide a simple bedside marker to identify patients at higher risk of postoperative cognitive dysfunction, enabling closer monitoring and earlier interventions.
How similar studies have gone: ONSD ultrasound is well validated as a noninvasive surrogate for raised intracranial pressure in other clinical settings, but its use to predict postoperative cognitive dysfunction after major cardiac surgery is preliminary and limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Bursa High Specialization Training and Research Hospital
Bursa, Yıldırım, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Anıl O Onur, MD — Bursa Yuksek Ihtisas Training and Research Hospital
- Study coordinator: Anıl O Onur, MD
- Email: dr.anilonur@gmail.com
- Phone: +905337244608
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.