Delirium Clinical Trial
Official title:
Postoperative Delirium: Brain Vulnerability and Recovery
Verified date | May 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | March 8, 2019 |
Est. primary completion date | March 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Common inclusion criteria: 1. Age = 60 2. Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement 3. English speaking. Common exclusion criteria: 1. Implanted pacemaker 2. Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated 3. Concomitant aortic or cerebrovascular procedure 4. Inability to lay flat or still for MRI 5. Legal blindness or severe deafness 6. Seizure history 7. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EEG During Delirium and After Recovery and in Patient Controls. | Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms. | Data acquisition will occur on 4 separate days between postoperative days 1-8. | |
Primary | Functional Connectivity Diffuse Optical Tomography (fcDOT) in Patients During Delirium and After Recovery and in Patient Controls | Functional connectivity between anterior and posterior Default Mode Network regions using diffuse optical imaging. | Data acquisition will occur on 4 separate days between postoperative days 1-8. | |
Primary | Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls. | 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 | Within one month after hospital discharge. |
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