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Cerebral Oximetry During Awake Carotid Endarterectomy

Key facts

Who runs it
Nguyen Toan Thang
Where
Vietnam1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
150 people, planned
Starts
1 Jan 2027
Expected to end
31 Oct 2028
Type of study
Observational
Treatments tested
  • Masked continuous cerebral oximetry
  • Standardised awake neurological test
  • Postoperative neurological and cognitive assessment
Record updated
12 November 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

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Who can take part

  • Age 18 years or older
  • Internal carotid artery stenosis of at least 50% if symptomatic or at least 70% if asymptomatic (NASCET criteria), with an indication for carotid endarterectomy according to the 2023 European Society for Vascular Surgery guidelines
  • Elective surgery planned under ultrasound-guided carotid sheath block combined with superficial cervical plexus block
  • Fully alert (Glasgow Coma Scale 15), able to communicate in Vietnamese, and able to perform the awake neurological test correctly at a preoperative rehearsal
  • Written informed consent. Exclusion Criteria
  • Emergency surgery or surgery within 48 hours of an acute stroke
  • Moderate or severe dementia, or psychiatric illness preventing cooperation; baseline Montreal Cognitive Assessment score below 18
  • Aphasia or contralateral limb weakness from previous stroke that prevents performance or interpretation of the awake neurological test; severe visual or hearing impairment
  • Refusal of regional anaesthesia, or general anaesthesia planned from the outset
  • Uncorrected severe coagulopathy, infection at the puncture site, or allergy to amide local anaesthetics
  • Previous ipsilateral neck radiotherapy or surgery requiring general anaesthesia; redo ipsilateral endarterectomy; simultaneous bilateral endarterectomy or a combined procedure
  • American Society of Anesthesiologists physical status IV or higher
  • Forehead skin lesions on the operated side or bilaterally preventing correct sensor placement
  • Acute illness affecting cognition at baseline (acute infection, decompensated hepatic or renal failure)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Surgery to remove plaque from the carotid artery in the neck requires the artery to be clamped for a period of time. In some patients this reduces blood flow to the brain enough to cause temporary symptoms, and a temporary plastic tube called a shunt is inserted to restore flow. When the operation is performed with the patient awake under a local anaesthetic block, doctors decide whether a shunt is needed by talking to the patient and checking the strength of the hand on the opposite side during clamping. This is called the awake neurological test.

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A cerebral oximeter measures the oxygen level in the front of the brain continuously and without needles, using light shone through the forehead. It could help patients who are asleep under general anaesthesia and cannot be tested. However, many earlier studies chose their alarm level after looking at their own results, or allowed the operating team to see the readings, which makes the device appear more accurate than it is.

In this study, 150 adults having planned carotid surgery under a local anaesthetic block will have a cerebral oximeter on the forehead throughout the operation. The screen will be covered so that the operating team cannot see the readings, and the decision to insert a shunt will be based only on the awake neurological test, as in current practice. The readings will be analysed only after surgery.

The main question is how accurately a fall in brain oxygen of 20% or more, a level chosen in advance from published research, identifies patients whose awake test becomes abnormal in the first three minutes of clamping, using only readings taken before the first abnormal sign. The second question is whether the amount of low brain oxygen before any treatment is related to stroke, temporary weakness or confusion in the first three days after surgery, and to change in a memory and thinking test score one month later.

The group in the trial

  • Single cohort - Carotid endarterectomy under regional anaesthesia

    Adults undergoing elective carotid endarterectomy under ultrasound-guided carotid sheath block combined with superficial cervical plexus block, monitored with continuous bilateral cerebral oximetry masked from the clinical team, with shunt decisions based solely on a standardised awake neurological test. Followed to 1 month after surgery.

    Treatment: Masked continuous cerebral oximetry, Standardised awake neurological test, and Postoperative neurological and cognitive assessment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Diagnostic Accuracy of Regional Cerebral Oxygen Saturation for Detecting Cross-clamp Cerebral Ischaemia and Its Prognostic Value for Postoperative Neurological Outcome in Carotid Endarterectomy Under Regional Anaesthesia: a Prospective, Single-centre, Index-test-blinded Observational Study
Record updated
12 November 2026