Carotid Artery Stenosis SymptomaticNCT07150260
Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry During Awake Carotid Endarterectomy
An observational study of Carotid Artery Stenosis Symptomatic and Carotid Endarterectomy (CEA) Surgical Patients, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to better understand how well the brain is perfused (supplied with blood and oxygen) during a specific type of surgery called carotid endarterectomy (CEA), which is performed to prevent strokes in people with stenosis of carotid arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis Symptomatic, Carotid Endarterectomy (CEA) Surgical Patients, Cerebral Hypoperfusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Oct 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients (≥18 years) undergoing elective carotid endarterectomy (CEA) under regional anesthesia at a single tertiary academic hospital. All participants must be able to tolerate awake surgery with regional anesthesia (superficial cervical plexus block) and undergo bilateral near-infrared spectroscopy (NIRS) monitoring and carotid stump pressure measurement during the procedure.
Who may be able to join
- Adults aged 18 years or older
- Scheduled for elective carotid endarterectomy (CEA)
- Able to tolerate surgery under regional anesthesia (superficial cervical plexus block)
- Availability of bilateral regional cerebral oxygen saturation (rSO₂) measurements by near-infrared spectroscopy (NIRS)
- Successful intraoperative carotid stump pressure (SP) measurement after cross-clamping
- Provided written informed consent
Who cannot join
- Incomplete NIRS or SP recordings
- Conversion from regional to general anesthesia
- Intraoperative technical complications preventing monitoring
- History of prior ipsilateral carotid endarterectomy or carotid artery stenting
- Recent major stroke with permanent neurological deficit
- Recent myocardial infarction within the past 3 months
- History of traumatic brain injury within the past 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Atatürk Training and Research Hospital
Izmir
About this study
Official title: Evaluation of the Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry in Awake Carotid Endarterectomy: A Prospective Cohort Study
This study aims to better understand how well the brain is perfused (supplied with blood and oxygen) during a specific type of surgery called carotid endarterectomy (CEA), which is performed to prevent strokes in people with stenosis of carotid arteries.
During this surgery, the surgeon temporarily clamps the carotid artery to remove a blockage, which can reduce blood flow to the brain. Monitoring brain oxygen levels during this time is important to prevent brain injury. Two common monitoring methods are:
Read more
Stump pressure (SP) - a pressure measurement taken from the carotid artery during surgery.
Near-infrared spectroscopy (NIRS) - a non-invasive technique that tracks brain oxygen levels in real time.
This study focuses on the relationship between carotid stump pressure and differences in brain oxygenation between the two sides of the brain (interhemispheric asymmetry), as measured by NIRS.
The study will include patients undergoing awake CEA (under regional anesthesia) at a single center university hospital. Oxygen levels in both hemispheres of the brain will be monitored before and after the carotid artery is clamped after 3 minutes. Stump pressure will also be measured. The researchers will examine whether low stump pressure is linked to greater differences in brain oxygen levels between the two sides.
The primary goal is to determine whether a large difference in brain oxygenation between the two hemispheres (greater than 10%) is associated with low carotid stump pressure. Secondary goals include identifying a stump pressure threshold that predicts significant asymmetry and analyzing the influence of patient and surgical factors.
The findings may help improve how surgeons and anesthesiologists monitor and protect the brain during CEA, particularly in patients who are awake and can be observed for neurological changes.
Read the detailed description
Carotid artery stenosis accounts for approximately 15-30% of ischemic strokes, highlighting the importance of carotid endarterectomy (CEA) as a preventive surgical strategy. One of the most critical intraoperative concerns during CEA is cerebral hypoperfusion at the time of carotid cross-clamping, when antegrade ipsilateral blood flow is interrupted. Monitoring cerebral oxygenation and collateral circulation during this period is essential to reduce the risk of ischemic complications. Traditionally, carotid stump pressure (SP) measurement has been used as a surrogate of collateral flow, whereas near-infrared spectroscopy (NIRS) provides a continuous, non-invasive estimate of regional cerebral oxygen saturation (rSO₂). While both tools are widely used, each has limitations, and there is no universal consensus on their predictive thresholds. Recent interest has shifted toward analyzing interhemispheric asymmetry in rSO₂ as a potentially physiological marker of cerebral perfusion adequacy in other clinical conditions.
This prospective, single-center observational cohort study will evaluate the association between carotid stump pressure and interhemispheric rSO₂ asymmetry in patients undergoing awake CEA under regional anesthesia. All patients will undergo awake CEA under regional anesthesia (superficial cervical plexus block) with bilateral NIRS monitoring and intraoperative stump pressure measurement. Data will be collected at baseline (before cross-clamping) and 3 minutes after carotid cross-clamp application. Patients will be stratified into two groups based on interhemispheric ΔrSO₂ asymmetry (>10% vs. ≤10%).
The primary objective is to determine whether stump pressure values differ significantly between patients with interhemispheric rSO₂ asymmetry greater than 10% (asymmetry group) compared with those with asymmetry of 10% or less (symmetry group).
Secondary objectives include:
Interhemispheric asymmetry difference;
Assessing the correlation between SP and interhemispheric ΔrSO₂ difference;
Assessing the correlation between SP and ipsilateral ΔrSO₂;
Identifying a carotid SP threshold predictive of significant interhemispheric asymmetry using receiver operating characteristic (ROC) curve analysis;
Evaluating the independent predictive value of SP for cerebral asymmetry using multivariable logistic regression adjusted for age, sex, degree of carotid stenosis, and intraoperative hemodynamic variables;
Comparing intraoperative hemodynamic parameters (PaO₂ (partial pressure of arterial oxygen), SpO₂ (peripheric oxygen saturation), systolic blood pressure, and heart rate) and procedural variables (need for shunt, cross-clamp duration, surgical time) between groups;
Documenting postoperative complications, including neurological deficits or bleeding, within 30 days of surgery.
A power analysis based on preliminary data (SP = 56 ± 15 mmHg in the symmetry group vs. 44 ±13 mmHg in the asymmetry group) yielded an effect size (Cohen's d) of 0.855. With α = 0.05 and 90% power, a minimum of 30 patients per group (60 total) are required to detect a significant difference in stump pressure between groups.
The findings of this study may refine intraoperative brain monitoring practices during CEA by clarifying the physiological relationship between stump pressure and cerebral oxygenation asymmetry.
- Conditions
- Carotid Artery Stenosis Symptomatic, Carotid Endarterectomy (CEA) Surgical Patients, Cerebral Hypoperfusion
- Keywords
- Carotid stump pressure, Near-infrared spectroscopy, rSO₂ asymmetry, Cerebral oxygenation, Awake carotid endarterectomy, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Asymmetry Group (>10% rSO₂ Difference) | This group includes patients who exhibit a significant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ greater than 10% between the ipsilateral (surgical) and contralateral hemispheres. | |
| Cerebral Symmetry Group (≤10% rSO₂ Difference) | This group includes patients who exhibit a nonsignificant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ lesser than 10% between the ipsilateral (surgical) and contralateral hemispheres. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Carotid Stump Pressure Between Interhemispheric rSO₂ Symmetry and Asymmetry Groups
The primary outcome is the comparison of intraoperative carotid stump pressure (SP) between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂ difference) and those with nonsignificant asymmetry (≤10%).
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Secondary outcomes (12)
Interhemispheric asymmetry difference
This outcome is the absolute difference in percentage change (ΔrSO₂) between the ipsilateral (surgical) and contralateral hemispheres during carotid cross-clamping, measured using near-infrared spectroscopy (NIRS).
Interhemispheric asymmetry is defined as:
ΔrSO₂ = (Post-clamp rSO₂ - Pre-clamp rSO₂) / Pre-clamp rSO₂ × 100 Interhemispheric asymmetry difference = ΔrSO₂ Ipsilateral - ΔrSO₂ Contralateral
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Correlation Between Carotid Stump Pressure and Interhemispheric ΔrSO₂ Difference
This outcome evaluates the relationship between carotid stump pressure and the absolute ΔrSO₂ difference between hemispheres (interhemispheric asymmetry) during carotid cross-clamping. The analysis will determine whether lower stump pressure values are significantly associated with increased interhemispheric cerebral oxygenation asymmetry.
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Correlation Between Carotid Stump Pressure and Ipsilateral ΔrSO₂
This outcome examines the association between carotid stump pressure and the percentage change in regional cerebral oxygen saturation (ΔrSO₂) specifically on the ipsilateral (surgical) hemisphere. ΔrSO₂ is calculated as the relative change from pre-clamp to post-clamp values using near-infrared spectroscopy (NIRS). The aim is to determine whether lower stump pressures are associated with greater ipsilateral desaturation, indicating impaired cerebral perfusion.
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Carotid Stump Pressure Threshold Predictive of rSO₂ Asymmetry Using ROC Curve Analysis
This outcome evaluates whether a specific carotid stump pressure threshold can predict significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂ difference). Receiver operating characteristic (ROC) curve analysis will be used to calculate sensitivity, specificity, and area under the curve (AUC) for predictive accuracy.
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Independent Predictive Value of Carotid Stump Pressure for rSO₂ Asymmetry in Multivariable Logistic Regression
This outcome assesses whether carotid stump pressure independently predicts the presence of interhemispheric rSO₂ asymmetry (>10%) during carotid cross-clamping. Logistic regression models will be adjusted for age, sex, degree of carotid stenosis, PaO₂, SpO₂, and systolic arterial pressure (SAP).
Measured: 3 minutes after carotid cross-clamping (intraoperative period)
Comparison of Intraoperative Arterial Pressures Between Asymmetry and Symmetry Groups
This outcome includes the comparison of intraoperative systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP), each measured in millimeters of mercury (mmHg), between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%).
Measured: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Heart Rate Between Asymmetry and Symmetry Groups
This outcome compares intraoperative heart rate (HR), measured in beats per minute (bpm), between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%).
Measured: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Arterial Oxygen Pressure (PaO₂) Between Asymmetry and Symmetry Groups
This outcome compares intraoperative arterial oxygen pressure (PaO₂), measured in millimeters of mercury (mmHg), between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%).
Measured: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Peripheral Oxygen Saturation (SpO₂) Between Asymmetry and Symmetry Groups
This outcome compares intraoperative peripheral oxygen saturation (SpO₂), expressed as a percentage (%), between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%).
Measured: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Cross-Clamp Duration, Total Surgical Time, and Total Anesthesia Time Between Asymmetry and Symmetry Groups
This outcome includes the comparison of three intraoperative time metrics - carotid cross-clamp duration, total surgical time, and total anesthesia time - each measured in minutes, between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%).
Measured: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Shunt Requirement Between Asymmetry and Symmetry Groups
This binary outcome compares the frequency of intraoperative shunt placement (yes/no) between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂) and those with nonsignificant asymmetry (≤10%). The aim is to assess whether cerebral oxygenation asymmetry is associated with an increased need for shunting during carotid surgery.
Measured: Intraoperative period (from anesthesia start to end of surgery)
Incidence of Postoperative Complications Within 30 Days
This outcome evaluates the incidence of postoperative complications occurring within 30 days after carotid endarterectomy. Complications of interest include new-onset neurological deficits (stroke, transient ischemic attack), bleeding requiring intervention, wound hematoma, or other clinically significant adverse events. Data will be collected through postoperative clinical assessments, follow-up visits, and review of medical records.
Measured: From date of surgery through postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery Stenosis SymptomaticStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Salih Tüzen, MD, Izmir Katip Celebi University
- Investigators
- Ahmet Salih Tüzen, M.D:, Principal investigator, Izmir Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150260
- Sponsor's protocol ID
- 2025-0442
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data necessary to support the study protocol, including de-identified individual participant data (IPD) related to intraoperative monitoring (e.g., stump pressure values, rSO₂ measurements, hemodynamic parameters), primary and secondary outcome measures, and 30-day postoperative follow-up results, will be made available upon reasonable request from qualified researchers for academic purposes, in accordance with institutional and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between Carotid Stump Pressure and Interhemispheric rSO₂ Asymmetry in Awake Carotid Endarterectomy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07150260
- Acronym / sponsor ID
- 2025-0442
- Conditions
- Carotid Artery Stenosis Symptomatic, Carotid Endarterectomy (CEA) Surgical Patients, Cerebral Hypoperfusion
- Keywords
- Carotid stump pressure, Near-infrared spectroscopy, rSO₂ asymmetry, Cerebral oxygenation, Awake carotid endarterectomy, Regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 2 Sep 2025 (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.
This study aims to better understand how well the brain is perfused (supplied with blood and oxygen) during a specific type of surgery called carotid endarterectomy (CEA), which is performed to prevent strokes in people with stenosis of carotid arteries.
During this surgery, the surgeon temporarily clamps the carotid artery to remove a blockage, which can reduce blood flow to the brain. Monitoring brain oxygen levels during this time is important to prevent brain injury. Two common monitoring methods are:
Stump pressure (SP) - a pressure measurement taken from the carotid artery during surgery.
Near-infrared spectroscopy (NIRS) - a non-invasive technique that tracks brain oxygen levels in real time.
This study focuses on the relationship between carotid stump pressure and differences in brain oxygenation between the two sides of the brain (interhemispheric asymmetry), as measured by NIRS.
The study will include patients undergoing awake CEA (under regional anesthesia) at a single center university hospital. Oxygen levels in both hemispheres of the brain will be monitored before and after the carotid artery is clamped after 3 minutes. Stump pressure will also be measured. The researchers will examine whether low stump pressure is linked to greater differences in brain oxygen levels between the two sides.
The primary goal is to determine whether a large difference in brain oxygenation between the two hemispheres (greater than 10%) is associated with low carotid stump pressure. Secondary goals include identifying a stump pressure threshold that predicts significant asymmetry and analyzing the influence of patient and surgical factors.
The findings may help improve how surgeons and anesthesiologists monitor and protect the brain during CEA, particularly in patients who are awake and can be observed for neurological changes.
Detailed description
Carotid artery stenosis accounts for approximately 15-30% of ischemic strokes, highlighting the importance of carotid endarterectomy (CEA) as a preventive surgical strategy. One of the most critical intraoperative concerns during CEA is cerebral hypoperfusion at the time of carotid cross-clamping, when antegrade ipsilateral blood flow is interrupted. Monitoring cerebral oxygenation and collateral circulation during this period is essential to reduce the risk of ischemic complications. Traditionally, carotid stump pressure (SP) measurement has been used as a surrogate of collateral flow, whereas near-infrared spectroscopy (NIRS) provides a continuous, non-invasive estimate of regional cerebral oxygen saturation (rSO₂). While both tools are widely used, each has limitations, and there is no universal consensus on their predictive thresholds. Recent interest has shifted toward analyzing interhemispheric asymmetry in rSO₂ as a potentially physiological marker of cerebral perfusion adequacy in other clinical conditions.
This prospective, single-center observational cohort study will evaluate the association between carotid stump pressure and interhemispheric rSO₂ asymmetry in patients undergoing awake CEA under regional anesthesia. All patients will undergo awake CEA under regional anesthesia (superficial cervical plexus block) with bilateral NIRS monitoring and intraoperative stump pressure measurement. Data will be collected at baseline (before cross-clamping) and 3 minutes after carotid cross-clamp application. Patients will be stratified into two groups based on interhemispheric ΔrSO₂ asymmetry (>10% vs. ≤10%).
The primary objective is to determine whether stump pressure values differ significantly between patients with interhemispheric rSO₂ asymmetry greater than 10% (asymmetry group) compared with those with asymmetry of 10% or less (symmetry group).
Secondary objectives include:
Interhemispheric asymmetry difference;
Assessing the correlation between SP and interhemispheric ΔrSO₂ difference;
Assessing the correlation between SP and ipsilateral ΔrSO₂;
Identifying a carotid SP threshold predictive of significant interhemispheric asymmetry using receiver operating characteristic (ROC) curve analysis;
Evaluating the independent predictive value of SP for cerebral asymmetry using multivariable logistic regression adjusted for age, sex, degree of carotid stenosis, and intraoperative hemodynamic variables;
Comparing intraoperative hemodynamic parameters (PaO₂ (partial pressure of arterial oxygen), SpO₂ (peripheric oxygen saturation), systolic blood pressure, and heart rate) and procedural variables (need for shunt, cross-clamp duration, surgical time) between groups;
Documenting postoperative complications, including neurological deficits or bleeding, within 30 days of surgery.
A power analysis based on preliminary data (SP = 56 ± 15 mmHg in the symmetry group vs. 44 ±13 mmHg in the asymmetry group) yielded an effect size (Cohen's d) of 0.855. With α = 0.05 and 90% power, a minimum of 30 patients per group (60 total) are required to detect a significant difference in stump pressure between groups.
The findings of this study may refine intraoperative brain monitoring practices during CEA by clarifying the physiological relationship between stump pressure and cerebral oxygenation asymmetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Asymmetry Group (>10% rSO₂ Difference) | – | –This group includes patients who exhibit a significant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ greater than 10% between the ipsilateral (surgical) and contralateral hemispheres. |
| Cerebral Symmetry Group (≤10% rSO₂ Difference) | – | –This group includes patients who exhibit a nonsignificant interhemispheric cerebral oxygenation asymmetry during awake carotid endarterectomy, defined as an absolute difference in ΔrSO₂ lesser than 10% between the ipsilateral (surgical) and contralateral hemispheres. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) undergoing elective carotid endarterectomy (CEA) under regional anesthesia at a single tertiary academic hospital. All participants must be able to tolerate awake surgery with regional anesthesia (superficial cervical plexus block) and undergo bilateral near-infrared spectroscopy (NIRS) monitoring and carotid stump pressure measurement during the procedure.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Scheduled for elective carotid endarterectomy (CEA)
- Able to tolerate surgery under regional anesthesia (superficial cervical plexus block)
- Availability of bilateral regional cerebral oxygen saturation (rSO₂) measurements by near-infrared spectroscopy (NIRS)
- Successful intraoperative carotid stump pressure (SP) measurement after cross-clamping
Key exclusion criteria (7 listed)
- Incomplete NIRS or SP recordings
- Conversion from regional to general anesthesia
- Intraoperative technical complications preventing monitoring
- History of prior ipsilateral carotid endarterectomy or carotid artery stenting
- Recent major stroke with permanent neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Carotid Stump Pressure Between Interhemispheric rSO₂ Symmetry and Asymmetry Groups
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
The primary outcome is the comparison of intraoperative carotid stump pressure (SP) between patients with significant interhemispheric cerebral oxygenation asymmetry (>10% ΔrSO₂ difference) and those with nonsignificant asymmetry (≤10%).
12 secondary outcomes
Interhemispheric asymmetry difference
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
Correlation Between Carotid Stump Pressure and Interhemispheric ΔrSO₂ Difference
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
Correlation Between Carotid Stump Pressure and Ipsilateral ΔrSO₂
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
Carotid Stump Pressure Threshold Predictive of rSO₂ Asymmetry Using ROC Curve Analysis
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
Independent Predictive Value of Carotid Stump Pressure for rSO₂ Asymmetry in Multivariable Logistic Regression
Time frame: 3 minutes after carotid cross-clamping (intraoperative period)
Comparison of Intraoperative Arterial Pressures Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Heart Rate Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Arterial Oxygen Pressure (PaO₂) Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Peripheral Oxygen Saturation (SpO₂) Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Cross-Clamp Duration, Total Surgical Time, and Total Anesthesia Time Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Comparison of Intraoperative Shunt Requirement Between Asymmetry and Symmetry Groups
Time frame: Intraoperative period (from anesthesia start to end of surgery)
Incidence of Postoperative Complications Within 30 Days
Time frame: From date of surgery through postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. All data necessary to support the study protocol, including de-identified individual participant data (IPD) related to intraoperative monitoring (e.g., stump pressure values, rSO₂ measurements, hemodynamic parameters), primary and secondary outcome measures, and 30-day postoperative follow-up results, will be made available upon reasonable request from qualified researchers for academic purposes, in accordance with institutional and ethical guidelines.
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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. This study is not recruiting at the moment.
Ahmet Salih Tüzen, M.D: principal investigator
Izmir Katip Celebi University Atatürk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis Symptomatic and Carotid Endarterectomy (CEA) Surgical Patients, run by Izmir Katip Celebi University 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Carotid Stump Pressure Between Interhemispheric rSO₂ Symmetry and Asymmetry Groups (time frame: 3 minutes after carotid cross-clamping (intraoperative period)). 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 4 Nov 2026.