跳至主要内容
临床试验/NCT05198635
NCT05198635招募中不适用

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

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Scheduled carotid endarterectomy; Signed informed consent.

排除标准

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

结局指标

主要结局

Postoperative delirium

时间窗: With postoperative 5 day

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.

次要结局

未报告次要终点

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuming Peng

Prof.

Beijing Tiantan Hospital

研究点 (1)

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