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临床试验/NCT03110185
NCT03110185已完成不适用

Postoperative Delirium: Brain Vulnerability and Recovery

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2015年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
EEG During Delirium and After Recovery and in Patient Controls.

研究概览

简要总结

In this study, we propose to use EEG and a brain imaging technique known as diffuse optical tomography (DOT) to study when people are in delirium and when they recovery. We plan to also compare brain function of patients who recovered from delirium to patients who did not have delirium using DOT and fMRI. We will also continually monitor the participant's EMR to help coordinate timing of study procedures, as well as to collect information pertaining to their surgery, recovery progress, and indicators of mental status including delirium.

详细描述

Postoperative delirium - a mental state of confusion, inattention, and impaired thought - is a potentially life-threatening condition. As many as half of patients that have heart and non heart-related surgery will experience postoperative delirium. Patients diagnosed with postoperative delirium have poorer outcomes and longer hospitalizations. Unfortunately, it is an under-diagnosed condition with a variable delay in when it appears. Additionally, there are no objective tools or tests that can be before or after surgery to anticipate and identify those patients who are at risk. Electroencephalography [EEG] and functional magnetic resonance imaging [fMRI] have helped us understand the changes in the brain during delirium. These suggest that a weakening in correlated activity within a group of brain regions, known as the default mode network (DMN), may be related to delirium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

EEG During Delirium and After Recovery and in Patient Controls.

时间窗: Data acquisition will occur on 4 separate days between postoperative days 1-8.

Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms.

Functional Connectivity Diffuse Optical Tomography (fcDOT) in Patients During Delirium and After Recovery and in Patient Controls

时间窗: Data acquisition will occur on 4 separate days between postoperative days 1-8.

Functional connectivity between anterior and posterior Default Mode Network regions using diffuse optical imaging.

Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls.

时间窗: Within one month after hospital discharge.

Functional connectivity between anterior and posterior Default Mode Network regions assessed from resting-state fcMRI acquired during eyes open wakefulness. Scored using r-value, using a scale of -1 to +1. -1 = strong negative correlation, +1 = strong positive correlation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben Palanca

Assistant Professor

Washington University School of Medicine

研究点 (2)

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