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Can a forehead light sensor spot hidden brain oxygen drops during carotid surgery?

NCT ID NCT07816081

Diagnosis Sponsor: Nguyen Toan Thang Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Carotid endarterectomy removes plaque from the neck artery, and surgeons clamp the artery briefly during the operation. In awake patients, doctors check hand strength and speech to decide if a shunt is needed. This study tests whether a forehead sensor that measures brain oxygen can detect the same problem, which could help patients who are asleep under general anaesthesia. Researchers will hide the sensor readings from the surgical team and compare them with the awake test in 150 adults.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cerebral oximetry using near-infrared spectroscopy
What this could lead to
If the oxygen readings match the awake test well, doctors could one day use a forehead sensor to spot reduced brain blood flow in patients who are asleep and cannot be tested by talking to them.
What could go wrong
The study is observational and single-centre, so it cannot prove the sensor improves outcomes. The 20% threshold comes from earlier research and may not hold up, and the oximeter readings are hidden from the surgical team, so they cannot guide care during this study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive adults with carotid artery stenosis scheduled for elective carotid endarterectomy under regional anaesthesia at a single tertiary referral centre in Hanoi, Vietnam.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older. * Internal carotid artery stenosis of at least 50% if symptomatic, or at least 70% if asymptomatic, measured by NASCET criteria, with an indication for carotid endarterectomy. * Elective surgery planned under regional anaesthesia using combined superficial cervical plexus and carotid sheath block. * Able to cooperate with awake neurological testing and with cognitive assessment. * Written informed consent. Exclusion Criteria: * Emergency or urgent surgery within 48 hours of an acute stroke. * Inability to cooperate with testing, including aphasia, dementia, a baseline Montreal Cognitive Assessment score below 18, or severe visual or hearing impairment. * Redo ipsilateral endarterectomy, simultaneous bilateral endarterectomy, or a combined procedure such as concomitant coronary artery bypass grafting. * Bilateral forehead skin lesions preventing sensor placement. * Known allergy or contraindication to lidocaine. * General anaesthesia planned from the outset.

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Conditions

The condition(s) this trial relates to.

brain ischemia carotid artery disorder carotid stenosis Emergence Delirium Postoperative Cognitive Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia, conduction Brain ischemia Carotid artery diseases Carotid endarterectomy Carotid stenosis Postoperative cognitive dysfunction (POCD) Postoperative delirium

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre of Anaesthesiology and Surgical Intensive Care, Bach Mai Hospital

    Hanoi, Phuongmai, 10000, Vietnam

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