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Cerebral Oximetry During Awake Carotid Endarterectomy

A legfontosabb adatok

Ki végzi
Nguyen Toan Thang
Hol
Vietnám1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
150 fő, tervezett
Kezdés
2027. jan. 1.
Várható befejezés
2028. okt. 31.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • Masked continuous cerebral oximetry
  • Standardised awake neurological test
  • Postoperative neurological and cognitive assessment
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

  • 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)

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A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • 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.

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

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

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

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
A regiszteradat frissítve
2026. november 12.