Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy

NCT06406842 NA RECRUITING

Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.

Details

Lead sponsor	Beijing Tiantan Hospital
Phase	NA
Status	RECRUITING
Enrolment	560
Start date	2024-07-08
Completion	2026-12

Conditions

• Carotid Endarterectomy
• Cerebral Autoregulation

Interventions

• Cerebral oxygenation index guided hemodynamics management

Primary outcomes

• The incidence of postoperative cerebral ischemic events — postoperative 3 day
  Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.

Countries

China