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Clinical Trials/NCT05198635
NCT05198635
Recruiting
Not Applicable

Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy:A Prospective Cohort Study

Beijing Tiantan Hospital1 site in 1 country140 target enrollmentFebruary 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Oxygen Saturation
Sponsor
Beijing Tiantan Hospital
Enrollment
140
Locations
1
Primary Endpoint
Postoperative delirium
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Postoperative delirium (POD) is a common perioperative complication, which can lead to adverse outcomes. Patients undergoing carotid endarterectomy (CEA) were elderly, complicated with vascular risk factors, cognitive dysfunction, some also had a history of stroke, and the circulation fluctuated greatly during the operation, often resulting in hypoperfusion of cerebral tissue and hypoxia. Therefore, they're the high-risk group of POD. Near-infrared Spectroscopy (NIRS) can continuously and noninvasively monitor local cerebral oxygen saturation (SctO2) to identify the mismatch of oxygen supply and demand in brain tissue. However, for CEA patients, the association between intraoperative SctO2 changes and POD remains unclear. This study intends to explore the association between them and determine the SctO2 threshold for predicting POD. We will monitor SctO2 intraoperatively, follow up and collect data postoperatively.

Registry
clinicaltrials.gov
Start Date
February 14, 2022
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuming Peng

Prof.

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Scheduled carotid endarterectomy; Signed informed consent.

Exclusion Criteria

  • Severe cognitive impairment(Mini-Mental State Examination, MMSE\<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers

Outcomes

Primary Outcomes

Postoperative delirium

Time Frame: With postoperative 5 day

Postoperative delirium is assessed by the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) when the patient is in intensive care unit or general ward, respectively.

Study Sites (1)

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