MedPath

Postoperative Delirium: Brain Vulnerability and Recovery

Not Applicable
Completed
Conditions
Delirium
Postoperative Complications
Interventions
Device: EEG
Device: fcDOT
Device: fcMRI
Registration Number
NCT03110185
Lead Sponsor
Washington University School of Medicine
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
91
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
deliriumEEGPatients 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.
no deliriumEEGPatients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm
deliriumfcDOTPatients 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.
no deliriumfcDOTPatients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm
deliriumfcMRIPatients 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.
no deliriumfcMRIPatients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm
Primary Outcome Measures
NameTimeMethod
EEG During Delirium and After Recovery and in Patient Controls.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 ControlsData 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.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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

🇺🇸

Saint Louis, Missouri, United States

© Copyright 2025. All Rights Reserved by MedPath