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Postoperative Delirium: Brain Vulnerability and Recovery

2020年5月23日更新者：Ben Palanca、Washington University School of Medicine

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Missouri
  - Saint Louis、Missouri、美国、63110
    - Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Common inclusion criteria:

Age ≥ 60
Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
English speaking.

Common exclusion criteria:

Implanted pacemaker
Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated
Concomitant aortic or cerebrovascular procedure
Inability to lay flat or still for MRI
Legal blindness or severe deafness
Seizure history
Known focal brain lesion larger than 3 cm.

Delirium Case Arm:

1. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5.

Postoperative Control Arm:

1. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：诊断
分配：非随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
其他：delirium Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.	设备：EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients 设备：fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients 设备：fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients
其他：no delirium Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm	设备：EEG Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients 设备：fcDOT Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients 设备：fcMRI Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. 其他名称： brain monitoring in delirious postoperative patients

参与者组/臂

干预/治疗

其他：delirium

Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.

设备：EEG