Postoperative Delirium: Brain Vulnerability and Recovery

NCT03110185 | Completed Results

• 1 other identifier: 201511004
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

delirium

OTHER

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.

Device: EEG; Device: fcDOT; Device: fcMRI

no delirium

OTHER

Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm

Device: EEG; Device: fcDOT; Device: fcMRI

Interventions

EEG DEVICE

Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.

Also known as: brain monitoring in delirious postoperative patients

delirium; no delirium

fcDOT DEVICE

Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.

Also known as: brain monitoring in delirious postoperative patients

delirium; no delirium

fcMRI DEVICE

Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.

Also known as: brain monitoring in delirious postoperative patients

delirium; no delirium

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

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

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Delirium; Postoperative Complications

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Results Point of Contact

• Title: Dr. Ben Palanca
• Organization: Washington University School of Medicine Department of Anesthesiology

palancab@wustl.edu

314-273-9076

Study Officials

• Ben Palanca, MD, PhD, MSc

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: April 12, 2017
• Study Start: November 25, 2015
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)