Association Between Local Cerebral Oxygenation Monitoring... | NCT05198635

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

NCT05198635

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Feb 13, 2025Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Cerebral Oxygen Saturation
Postoperative Delirium
Carotid Endarterectomy

Interventions

local cerebral oxygen saturation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 4, 2022

First Submission Date that Met QC Criteria

Jan 15, 2022

First Posted Date

Jan 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Device: local cerebral oxygen saturation
Group 2			Device: local cerebral oxygen saturation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
local cerebral oxygen saturation	Device	minimum SctO2, SctO2 drop/rise defined by different thresholds, and area under/above the threshold	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Scheduled carotid endarterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuming MD Peng, Ph.D	Contact	8610-59976658		florapym766@163.com

Overall Officials

Name	Affiliation	Role
Yuming MD Peng, Ph.D	Beijing Tiantan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tian Tan Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality	100160	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

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