Association Between Local Cerebral Oxygenation Monitoring and Postoperative Delirium in Carotid Endarterectomy
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 140 people, planned
- Started
- 14 Feb 2022
- Planned end
- 31 Dec 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- local cerebral oxygen saturation
- Record updated
- 13 February 2025
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Scheduled carotid endarterectomy; Signed informed consent
Who cannot take part
- Severe cognitive impairment(Mini-Mental State Examination, MMSE<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group 1
Treatment: local cerebral oxygen saturation
- Group 2
Treatment: local cerebral oxygen saturation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study
- Record updated
- 13 February 2025