This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
227
Bedside multimodal cerebral autoregulation monitoring performed immediately after successful mechanical thrombectomy (mTICI 2b-3). Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive arterial blood pressure measurement for 25-30 minutes. Cerebral oxygenation index (COx) is calculated as a moving Pearson correlation coefficient between mean arterial pressure and cerebral oxygen saturation over 30 consecutive 10-second epochs (300 seconds). COx ≥ 0.3 indicates impaired cerebral autoregulation, while COx \< 0.3 indicates preserved autoregulation. Changes in cerebral oxygen saturation before and after carotid compression are also used to assess autoregulatory.
A carotid compression test is performed by compressing the common carotid artery at the lower one-third of the neck (avoiding the carotid sinus) against the transverse process of C6 until pulsation disappears for 5-10 seconds, followed by release. If the brain oxygen saturation has increased compared to before the test, it indicates that the brain's automatic blood flow regulation function is intact; conversely, if it has decreased, it is regarded as a damaged automatic blood flow regulation function of the brain.
Beijing Shijitan Hospital, Capital Medical University
Beijing, China
RECRUITINGCentral Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
Dalian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Heilongjiang, China
NOT_YET_RECRUITINGWeifang People's Hospital Affiliated to Weifang Medical University
Shandong, China
RECRUITINGDistribution of Modified Rankin scale
the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\]
Time frame: 90±7days
Early neurological improvement
Early neurological improvement is defined as a reduction of ≥8 on the National Institutes of Health Stroke Scale \[ranging from 0 to 42 points, with higher numbers indicating greater severity\] or National nstitutes of Health Stroke Scale zero to one 24 hours after thrombectomy.
Time frame: 24±12 hours
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