Comparison of Cerebral Oximetry and Neurological Status Testing in the Awake Patient in the Detection of Cerebral Ischemia During Carotid Endarterectomy

NCT07485933 | Active Not Recruiting

• 1 other identifier: 1787/38-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study compares two methods of intraoperative cerebral ischemia monitoring during carotid endarterectomy performed under regional anesthesia: neurological testing in the awake patient and near-infrared spectroscopy (NIRS). The study aims to determine whether NIRS is equivalent to awake neurological testing in detecting cerebral ischemia during carotid artery clamping and in guiding the use of an intraluminal shunt.

Conditions

Carotid Arteriosclerosis; Near Infrared Spectroscopy

Keywords

Stenosing occlusive carotid disease; carotid endarterectomy; protective shunt; neuromonitoring; near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• primary outcome

  to compare the incidence of intraoperative cerebral ischemia during carotid artery clamping in carotid endarterectomy when tested in the awake state, i.e. by spectroscopy (NIRS method)

  two years

Secondary Outcomes (1)

• Secondary outcome

  2 years

Other Outcomes (1)

• Secondary Outcome Measure 2

  2 years

Study Arms (2)

Awake Neurological Testing (TUBS) Group

ACTIVE COMPARATOR

Patients in this group will undergo carotid endarterectomy under regional anesthesia. Intraluminal shunt placement will be guided by awake neurological testing, including verbal communication and contralateral hand motor function, to detect intraoperative cerebral ischemia. NIRS monitoring will be recorded but will not guide shunt use.

Behavioral: Awake Neurological Testing

Near-Infrared Spectroscopy (NIRS) Group

ACTIVE COMPARATOR

Patients in this group will undergo carotid endarterectomy under regional anesthesia. Intraluminal shunt placement will be guided by near-infrared spectroscopy (NIRS), with shunt use indicated by a decrease of more than 20% in cerebral oxygenation compared to baseline. Awake neurological testing will be performed and recorded but will not guide shunt placement.

Device: Near-Infrared Spectroscopy (NIRS) Monitoring

Interventions

Near-Infrared Spectroscopy (NIRS) Monitoring DEVICE

Continuous monitoring of regional cerebral oxygen saturation during carotid endarterectomy under regional anesthesia. Intraluminal shunt placement is guided by a decrease of more than 20% from baseline NIRS values. Awake neurological testing is recorded but not used for shunt decisions.

Near-Infrared Spectroscopy (NIRS) Group

Awake Neurological Testing BEHAVIORAL

Neurological monitoring during carotid endarterectomy under regional anesthesia. Intraluminal shunt placement is guided by verbal communication and contralateral hand motor testing to detect cerebral ischemia. NIRS monitoring is recorded but not used to guide shunt placement.

Awake Neurological Testing (TUBS) Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with asymptomatic and symptomatic narrowing of the carotid artery in whom operative treatment is indicated, diagnosed by initial Duplex ultrasonographic examination or CT angiography.
• Written consent of the patient to participate in the study

You may not qualify if:

• \- previous hemorrhagic stroke
• non-atherosclerotic carotid disease
• significant atherosclerotic changes in the aortic arch
• hypercoagulable and conditions with embologenic potential (congenital or acquired thrombophilia, malignant disease, atrial fibrillation, significant heart failure and valvular disease)

Sponsors & Collaborators

• Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia: lead

Study Sites (1)

Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial compares awake neurological testing and near-infrared spectroscopy (NIRS) for detecting intraoperative cerebral ischemia during carotid endarterectomy under regional anesthesia. The study evaluates whether NIRS is equivalent to awake testing in identifying cerebral hypoperfusion and guiding intraluminal shunt placement.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 20, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

SE (1)