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NCT05198635 Clinical Trial

Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05198635
Other study ID # 20220105
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2022
Est. completion date December 31, 2023

Study information
Verified date February 2022
Source Beijing Tiantan Hospital
Contact Yuming MD Peng, Ph.D
Phone 8610-59976658
Email florapym766@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• local cerebral oxygen saturation
minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold

Locations
Country Name City State
China Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative delirium 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. With postoperative 5 day
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