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

NCT05198635 | Recruiting

• 1 other identifier: 20220105
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Oxygen Saturation; Postoperative Delirium; Carotid Endarterectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

Device: local cerebral oxygen saturation

Group 2

Device: local cerebral oxygen saturation

Interventions

local cerebral oxygen saturation DEVICE

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

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Scheduled carotid endarterectomy

You may qualify if:

• Scheduled carotid endarterectomy; Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100160, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuming MD Peng, Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming MD Peng, Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 20, 2022
• Study Start: February 14, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)