Aortic DiseasesSACP-ONSDNCT07800806
Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery
A study testing Optic nerve sheath and optic nerve diameter ultrasonography and Transcranial Doppler ultrasonography in people with Aortic Diseases and Cardiac Surgical Procedures, run by Koşuyolu Kartal Heart Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Cardiac Surgical Procedures, Aortic Aneurysm, Thoracic
- What is being tested?
- Optic nerve sheath and optic nerve diameter ultrasonography and Transcranial Doppler ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kosuyolu Heart Training and Research Hospital
Istanbul, Kartal, 34862
Ebru Girgin Dinc, MD, Anesthesiologist, 905446948852, grgnebru@gmail.com
About this study
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
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.
Read the detailed description
This single-center prospective study will enroll adults undergoing elective or urgent ascending aortic surgery with planned axillary artery cannulation. Participants are grouped according to whether release of the aortic cross-clamp is required to construct the distal anastomosis, and therefore whether selective antegrade cerebral perfusion is applied. Group membership follows from the intraoperative surgical requirement and is not assigned by the investigators. All participants receive a single protocol-specified general anesthesia and ventilation regimen, identical in both groups, so that variables known to act on optic nerve sheath diameter, in particular arterial carbon dioxide tension, volatile agent concentration and airway pressure, are held constant. Because this regimen is assigned by the protocol, the study is registered as interventional. Bilateral optic nerve sheath diameter and optic nerve diameter will be measured by ultrasonography, and middle cerebral artery mean flow velocity by transcranial Doppler, at three time points: before anesthesia induction (T0), at the end of surgery after hemodynamic stabilization in the operating room (T1), and at postoperative hour 24 in the intensive care unit (T2). Regional cerebral oxygen saturation by near-infrared spectroscopy and the electroencephalographic suppression ratio derived from bispectral index monitoring will be recorded intraoperatively. Delirium will be screened at postoperative hour 24 using the Nursing Delirium Screening Scale (Nu-DESC), with a total score of 2 or more considered a positive screen. The primary outcome is the change in bilateral mean optic nerve sheath diameter across T0, T1 and T2, evaluated as the group-by-time interaction in a linear mixed-effects model.
- Conditions
- Aortic Diseases, Cardiac Surgical Procedures, Aortic Aneurysm, Thoracic, Delirium - Postoperative, Postoperative Complications (Cardiopulmonary), Postoperative Complications
- Being tested
- Optic nerve sheath and optic nerve diameter ultrasonography, Transcranial Doppler ultrasonography
- Keywords
- Optic nerve sheath diameter, Selective antegrade cerebral perfusion, Ascending aortic surgery, Circulatory arrest, Cardiopulmonary bypass, Postoperative delirium, Nursing Delirium Screening Scale, Transcranial Doppler ultrasonography, Middle cerebral artery mean flow velocity, Near-infrared spectroscopy, Suppression ratio, Cerebral protection
- Medical subject headings
- Aortic Diseases, Aortic Aneurysm, Thoracic, Emergence Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath and optic nerve diameter ultrasonographyDiagnostic test
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 ultrasonographyDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Group SACP: cross-clamp release required | Other | 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. Receives: Diagnostic Test: Optic nerve sheath and optic nerve diameter ultrasonography; Diagnostic Test: Transcranial Doppler ultrasonography |
| Group Non-SACP: cross-clamp release not required | Other | 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. Receives: Diagnostic Test: Optic nerve sheath and optic nerve diameter ultrasonography; Diagnostic Test: Transcranial Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bilateral mean optic nerve sheath diameter (ONSD) over time
Optic nerve sheath diameter in millimetres, measured by ocular ultrasonography 3 mm posterior to the entry of the optic nerve into the globe in the transverse plane. Three measurements are obtained per eye and averaged; the mean of the right and left eye values is the participant value. Higher values indicate a larger sheath diameter and are interpreted as consistent with a higher intracranial pressure. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction term in a linear mixed-effects model with a random intercept for participant.
Measured: From before anesthesia induction to postoperative hour 24
Secondary outcomes (6)
Change in bilateral mean optic nerve diameter (OND) over time
Optic nerve diameter in millimetres, measured at the same level as the sheath diameter between the outer margins of the nerve, excluding the sheath. Three measurements per eye are averaged and the mean of the two eyes is the participant value. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction term in a linear mixed-effects model with a random intercept for participant. Measurements are obtained before anesthesia induction, at the end of surgery after hemodynamic stabilization in the operating room, and at postoperative hour 24 in the intensive care unit.
Measured: From before anesthesia induction to postoperative hour 24
Change in middle cerebral artery mean flow velocity measured by transcranial Doppler
Mean flow velocity in centimetres per second in the M1 segment of the middle cerebral artery, insonated through the temporal window at approximately 45-55 mm depth. Three consecutive stable measurements per side are averaged and the bilateral mean is the participant value. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction in a linear mixed-effects model. This analysis is exploratory. Measurements are obtained before anesthesia induction, at the end of surgery after hemodynamic stabilization in the operating room, and at postoperative hour 24 in the intensive care unit.
Measured: From before anesthesia induction to postoperative hour 24
Change in regional cerebral oxygen saturation measured by near-infrared spectroscopy
Bilateral regional cerebral oxygen saturation as a percentage, recorded by near-infrared spectroscopy with adhesive frontal sensors. Baseline value, nadir value, percentage change from baseline, number of desaturation episodes at or beyond a 20 percent relative fall from baseline, and total duration of desaturation in minutes are recorded for each side. Values are recorded before anesthesia induction, before cardiopulmonary bypass, before and after selective antegrade cerebral perfusion, at the end of cardiopulmonary bypass, and at the end of surgery.
Measured: From before anesthesia induction to the end of surgery
Proportion of participants with a positive delirium screen (Nu-DESC >=2)
Delirium screened with the Nursing Delirium Screening Scale, a five-item observational scale scored 0 to 2 per item for a total range of 0 to 10, where higher scores indicate more delirium features. A total score of 2 or more is a positive screen. Screening is performed once the participant is sufficiently awake and communicative; where deep sedation precludes assessment the screen is repeated at an appropriate time and the delay recorded.
Measured: At postoperative hour 24
Number of participants with a clinical neurological event
Composite of stroke, transient ischemic attack, seizure, or a new focal neurological deficit, ascertained from clinical records and bedside neurological examination. Each component is reported separately in addition to the composite. Events are recorded from the end of surgery to hospital discharge.
Measured: From end of surgery to hospital discharge, up to 30 days
Cumulative intraoperative electroencephalographic suppression time
Total time in minutes for which the electroencephalogram is suppressed, derived from continuous bispectral index monitoring with an adhesive frontal sensor. Suppression time is accumulated from anesthesia induction to the end of surgery and reported in total and separately for the period of cardiopulmonary bypass and, where applicable, for the period of selective antegrade cerebral perfusion and systemic circulatory arrest. Higher values indicate a longer cumulative duration of an isoelectric electroencephalogram. The proportion of participants with any recorded suppression is reported alongside the duration.
Measured: From before anesthesia induction to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive the same protocol-specified general anesthesia and ventilation regimen, which constitutes the assigned intervention and is identical in both arms. Participants are not allocated to arms by the investigators. Arm membership is determined by whether release of the aortic cross-clamp is required to construct the distal anastomosis, which follows from the extent of the aortic pathology and the geometry of the graft. Participants in whom the cross-clamp is released undergo systemic circulatory arrest with selective antegrade cerebral perfusion; participants in whom the anastomosis can be completed with the cross-clamp maintained do not. The study is classified as interventional because the anesthetic and ventilatory regimen is assigned by the protocol, not because the cerebral protection strategy is assigned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koşuyolu Kartal Heart Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800806
- Sponsor's protocol ID
- SACP-ONSD-2026-01
- Acronym
- SACP-ONSD
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available to investigators whose proposed use is judged scientifically appropriate. Requests are directed to the principal investigator and are assessed for scientific merit and for consistency with the consent given by participants. Data are released only after the request has been approved by the institutional clinical research ethics committee, and only in de-identified form. The code linking participants to study numbers is retained by the principal investigator and is never shared. Approved requesters must sign a data use agreement specifying the approved analysis, prohibiting any attempt at re-identification and prohibiting onward transfer to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07800806
- Acronym / sponsor ID
- SACP-ONSD / SACP-ONSD-2026-01
- Conditions
- Aortic Diseases, Cardiac Surgical Procedures, Aortic Aneurysm, Thoracic, Delirium - Postoperative, Postoperative Complications (Cardiopulmonary), Postoperative Complications
- Keywords
- Optic nerve sheath diameter, Selective antegrade cerebral perfusion, Ascending aortic surgery, Circulatory arrest, Cardiopulmonary bypass, Postoperative delirium, Nursing Delirium Screening Scale, Transcranial Doppler ultrasonography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Koşuyolu Kartal Heart Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-center prospective study will enroll adults undergoing elective or urgent ascending aortic surgery with planned axillary artery cannulation. Participants are grouped according to whether release of the aortic cross-clamp is required to construct the distal anastomosis, and therefore whether selective antegrade cerebral perfusion is applied. Group membership follows from the intraoperative surgical requirement and is not assigned by the investigators. All participants receive a single protocol-specified general anesthesia and ventilation regimen, identical in both groups, so that variables known to act on optic nerve sheath diameter, in particular arterial carbon dioxide tension, volatile agent concentration and airway pressure, are held constant. Because this regimen is assigned by the protocol, the study is registered as interventional. Bilateral optic nerve sheath diameter and optic nerve diameter will be measured by ultrasonography, and middle cerebral artery mean flow velocity by transcranial Doppler, at three time points: before anesthesia induction (T0), at the end of surgery after hemodynamic stabilization in the operating room (T1), and at postoperative hour 24 in the intensive care unit (T2). Regional cerebral oxygen saturation by near-infrared spectroscopy and the electroencephalographic suppression ratio derived from bispectral index monitoring will be recorded intraoperatively. Delirium will be screened at postoperative hour 24 using the Nursing Delirium Screening Scale (Nu-DESC), with a total score of 2 or more considered a positive screen. The primary outcome is the change in bilateral mean optic nerve sheath diameter across T0, T1 and T2, evaluated as the group-by-time interaction in a linear mixed-effects model.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants receive the same protocol-specified general anesthesia and ventilation regimen, which constitutes the assigned intervention and is identical in both arms. Participants are not allocated to arms by the investigators. Arm membership is determined by whether release of the aortic cross-clamp is required to construct the distal anastomosis, which follows from the extent of the aortic pathology and the geometry of the graft. Participants in whom the cross-clamp is released undergo systemic circulatory arrest with selective antegrade cerebral perfusion; participants in whom the anastomosis can be completed with the cross-clamp maintained do not. The study is classified as interventional because the anesthetic and ventilatory regimen is assigned by the protocol, not because the cerebral protection strategy is assigned.
| Arm | Type | Receives |
|---|---|---|
| Group SACP: cross-clamp release required | Other | Diagnostic Test: Optic nerve sheath and optic nerve diameter ultrasonography, Diagnostic Test: Transcranial Doppler ultrasonographyParticipants 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. |
| Group Non-SACP: cross-clamp release not required | Other | Diagnostic Test: Optic nerve sheath and optic nerve diameter ultrasonography, Diagnostic Test: Transcranial Doppler ultrasonographyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath and optic nerve diameter ultrasonographyOcular 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. | Diagnostic test | Group Non-SACP: cross-clamp release not required, Group SACP: cross-clamp release required |
| Transcranial Doppler ultrasonographyTranscranial 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. | Diagnostic test | Group Non-SACP: cross-clamp release not required, Group SACP: cross-clamp release required |
Primary outcome
Change in bilateral mean optic nerve sheath diameter (ONSD) over time
Time frame: From before anesthesia induction to postoperative hour 24
Optic nerve sheath diameter in millimetres, measured by ocular ultrasonography 3 mm posterior to the entry of the optic nerve into the globe in the transverse plane. Three measurements are obtained per eye and averaged; the mean of the right and left eye values is the participant value. Higher values indicate a larger sheath diameter and are interpreted as consistent with a higher intracranial pressure. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction term in a linear mixed-effects model with a random intercept for participant.
6 secondary outcomes
Change in bilateral mean optic nerve diameter (OND) over time
Time frame: From before anesthesia induction to postoperative hour 24
Change in middle cerebral artery mean flow velocity measured by transcranial Doppler
Time frame: From before anesthesia induction to postoperative hour 24
Change in regional cerebral oxygen saturation measured by near-infrared spectroscopy
Time frame: From before anesthesia induction to the end of surgery
Proportion of participants with a positive delirium screen (Nu-DESC >=2)
Time frame: At postoperative hour 24
Number of participants with a clinical neurological event
Time frame: From end of surgery to hospital discharge, up to 30 days
Cumulative intraoperative electroencephalographic suppression time
Time frame: From before anesthesia induction to the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be made available to investigators whose proposed use is judged scientifically appropriate. Requests are directed to the principal investigator and are assessed for scientific merit and for consistency with the consent given by participants. Data are released only after the request has been approved by the institutional clinical research ethics committee, and only in de-identified form. The code linking participants to study numbers is retained by the principal investigator and is never shared. Approved requesters must sign a data use agreement specifying the approved analysis, prohibiting any attempt at re-identification and prohibiting onward transfer to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve sheath and optic nerve diameter ultrasonography and Transcranial Doppler ultrasonography in people with Aortic Diseases and Cardiac Surgical Procedures, run by Koşuyolu Kartal Heart Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Girgin Dinc, M.D., DESAIC (905446948852, grgnebru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bilateral mean optic nerve sheath diameter (ONSD) over time (time frame: From before anesthesia induction to postoperative hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.