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All Genders
ID05198635

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

Led by Beijing Tiantan Hospital · Updated on 2025-02-13

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative delirium (POD) is a common complication seen after surgery, especially in elderly patients undergoing carotid endarterectomy (CEA). These patients often have vascular risks, cognitive issues, or a history of stroke, which combined with fluctuating blood flow during surgery can lead to reduced oxygen supply to brain tissue. This trial aims to study how changes in local cerebral oxygen saturation (SctO2) during surgery relate to the development of POD and to find the SctO2 levels that predict POD in this high-risk group. The study observes patients undergoing CEA and continuously monitors their brain oxygen levels using Near-infrared Spectroscopy (NIRS) during surgery. This device noninvasively measures the oxygen saturation in cerebral tissue to detect any imbalance between oxygen supply and demand. No treatments are assigned; instead, the study gathers data on SctO2 changes throughout the operation to understand their association with postoperative delirium. Participants will be followed for five days after surgery to monitor and record any signs of postoperative delirium. Researchers will collect and analyze these data to evaluate the relationship between intraoperative oxygen saturation and POD occurrence. This prospective cohort study is sponsored by Beijing Tiantan Hospital and is expected to end in December 2025.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled carotid endarterectomy
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment with Mini-Mental State Examination score less than 18
  • History of psychotropic drug use
  • Previous intracranial surgery
  • Poor hearing or vision
  • Language barriers affecting participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo carotid endarterectomy surgery with monitoring of local cerebral oxygen saturation during the procedure and immediate post-operative period.

1 hospital stay including surgery day

Post-operative Follow-up

Duration - 5 days

Participants are monitored for postoperative delirium for 5 days after surgery.

Daily assessments for up to 5 days post-surgery

Trial Site Locations

Total: 1 location

1

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100160

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Research Team

Y

Yuming MD Peng, Ph.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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