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

NCT ID: NCT05198635

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Oxygen Saturation Postoperative Delirium Carotid Endarterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

local cerebral oxygen saturation

Intervention Type DEVICE

minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold

Group 2

local cerebral oxygen saturation

Intervention Type DEVICE

minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold

Interventions

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local cerebral oxygen saturation

minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuming Peng

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuming MD Peng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tian Tan Hospital

Locations

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Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuming MD Peng, Ph.D

Role: CONTACT

8610-59976658

Facility Contacts

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Yuming Peng

Role: primary

8610-59976658

Other Identifiers

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20220105

Identifier Type: -

Identifier Source: org_study_id

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