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Clinical Trials in Turkey / NCT07800806
Starting soon Not applicable

Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery

NCT07800806 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-30
Last updated
2026-09-02

Condition(s) studied

Aortic DiseasesCardiac Surgical ProceduresAortic Aneurysm, ThoracicDelirium - PostoperativePostoperative Complications (Cardiopulmonary)Postoperative ComplicationsCerebrovascular Circulation

Investigational drug(s) / intervention(s)

Optic nerve sheath and optic nerve diameter ultrasonographyTranscranial Doppler ultrasonography

Optic nerve sheath and optic nerve diameter ultrasonography: Ocular ultrasonography with a linear probe of approximately 7-13 MHz, participant supine with the head neutral, eyelids closed, sterile transparent dressing and gel, minimal probe pressure. Optic nerve sheath diameter is measured in the transverse plane 3 mm posterior to the entry of the optic nerve into the globe. Three measurements per eye are averaged, and the mean of the two eyes is recorded. Performed at T0, T1 and T2.

Transcranial Doppler ultrasonography: Transcranial Doppler ultrasonography with a 2 MHz pulsed-wave probe. The M1 segment of the middle cerebral artery is insonated through the temporal window at approximately 45-55 mm depth, bilaterally where a window is obtainable. Three consecutive stable mean flow velocity measurements are taken per side and averaged. Performed at T0, T1 and T2, and where technically feasible during selective antegrade cerebral perfusion and/or circulatory arrest.

Study summary

In ascending aortic surgery the distal anastomosis may be constructed with the aortic cross-clamp maintained, or, where the extent of the aortic pathology and the geometry of the graft require it, after release of the cross-clamp during a period of systemic circulatory arrest. Both are established surgical approaches. Where the cross-clamp is released, selective antegrade cerebral perfusion (SACP) is an established cerebral protection technique and is applied for that purpose. Where release of the cross-clamp is not required, systemic circulatory arrest is avoided and SACP is not applied. Optic nerve sheath diameter (ONSD) measured by ocular ultrasonography is a non-invasive marker of raised intracranial pressure. Cardiopulmonary bypass may increase blood-brain barrier permeability through hypoperfusion, non-pulsatile flow, hemodilution and systemic inflammation, predisposing to cerebral edema. Perioperative increases in ONSD have been reported after open heart surgery and have been associated with postoperative delirium. Data on how SACP influences perioperative ONSD dynamics in ascending aortic surgery, and whether such changes relate to postoperative delirium, are limited.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older * Planned or urgent, hemodynamically stable ascending aortic surgery, including supracoronary ascending aortic replacement, aortic root replacement (Bentall procedure) or valve-sparing root surgery (David procedure), limited to cases involving the ascending aortic segment * Perfusion planned through axillary artery cannulation * Written informed consent Exclusion Criteria: * History of intracranial procedure or intracranial pathology * Previous carotid intervention, or carotid artery stenosis of 50 percent or more on preoperative Doppler ultrasonography * Advanced chronic obstructive pulmonary disease, defined clinically as advanced stage disease with long-term oxygen therapy or a history of frequent exacerbations * Baseline arterial carbon dioxide tension of 55 mmHg or higher on preoperative arterial blood gas analysis * Ocular pathology, ocular surgery or ocular trauma that could affect measurement of the optic nerve sheath or optic nerve, including glaucoma and retinal detachment or fibrosis * Severe preoperative neurological deficit, including major stroke or severe dementia, or active psychiatric illness * Hemodynamic instability, or a requirement for extracorporeal membrane oxygenation or intra-aortic balloon counterpulsation, of a degree that prevents measurements during the first 24 postoperative hours * Known contraindication to any component of the protocol-specified anesthesia regimen

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kosuyolu Heart Training and Research Hospital Istanbul Kartal

More Koşuyolu Kartal Heart Training and Research Hospital trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07800806 on ClinicalTrials.gov ↗ ← All trials in Turkey