Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery
Key facts
- Who runs it
- Koşuyolu Kartal Heart Training and Research Hospital
- Where
- Istanbul, TürkiyeSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 134 people, planned
- Started
- 30 Sept 2026
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Optic nerve sheath and optic nerve diameter ultrasonography
- Transcranial Doppler ultrasonography
- Record updated
- 2 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous carotid intervention, or carotid artery stenosis of 50 percent or more on preoperative Doppler ultrasonography
- 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
- History of intracranial procedure or intracranial pathology
- Advanced chronic obstructive pulmonary disease, defined clinically as advanced stage disease with long-term oxygen therapy or a history of frequent exacerbations
- Severe preoperative neurological deficit, including major stroke or severe dementia, or active psychiatric illness
- Baseline arterial carbon dioxide tension of 55 mmHg or higher on preoperative arterial blood gas analysis
- 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
Where in Türkiye
- Kosuyolu Heart Training and Research HospitalIstanbul, TürkiyeContact: Ebru Girgin Dinc, MD, AnesthesiologistNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group SACP: cross-clamp release requiredOther group
Participants in whom the extent of the aortic pathology and the geometry of the graft require release of the aortic cross-clamp to construct the distal anastomosis, and who therefore undergo a period of systemic circulatory arrest with selective antegrade cerebral perfusion for cerebral protection. Perfusion is delivered through axillary artery cannulation; type (unilateral or bilateral), cannulation site, flow, target pressure and duration are recorded. Membership of this arm follows from the intraoperative surgical requirement and is not assigned by the investigators. The protocol-specified anesthesia and ventilation regimen and all study assessments are applied identically in both arms.
Treatment: Optic nerve sheath and optic nerve diameter ultrasonography and Transcranial Doppler ultrasonography
- Group Non-SACP: cross-clamp release not requiredOther group
Participants in whom release of the aortic cross-clamp is not required, the extent of the aortic pathology and the length of the graft permitting the distal anastomosis to be completed with the cross-clamp maintained. These participants do not undergo systemic circulatory arrest and selective antegrade cerebral perfusion is not applied. Membership of this arm follows from the intraoperative surgical requirement and is not assigned by the investigators. The protocol-specified anesthesia and ventilation regimen and all study assessments are applied identically in both arms.
Treatment: Optic nerve sheath and optic nerve diameter ultrasonography and Transcranial Doppler ultrasonography
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Selective Antegrade Cerebral Perfusion as a Cerebral Protection Strategy in Ascending Aortic Surgery: Perioperative Changes in Ultrasonographic Optic Nerve Sheath Diameter. A Single-Center Prospective Observational Cohort Study
- Record updated
- 2 September 2026