NCT05198635 Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy
| NCT ID | NCT05198635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Cerebral Oxygen Saturation |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-02-14 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2022-02-14 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Yuming MD Peng, Ph.D
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT05198635 clinical trial?
This trial is open to participants of all sexes, studying Cerebral Oxygen Saturation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05198635 currently recruiting?
Yes, NCT05198635 is actively recruiting participants. Contact the research team at florapym766@163.com for enrollment information.
Where is the NCT05198635 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05198635 clinical trial?
NCT05198635 is sponsored by Beijing Tiantan Hospital. The principal investigator is Yuming MD Peng, Ph.D at Beijing Tiantan Hospital. The trial plans to enroll 140 participants.