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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG | Device | Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Common inclusion criteria:
Common exclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ben Palanca, MD, PhD, MSc | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine | St Louis | Missouri | 63110 | United States |
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Participants were not assigned to groups, as baseline delirium status determined which group the participants fell into (delirium vs. no delirium).
Participants were either recruited pre- or post-operatively for study procedures depending on availability of equipment and research staff.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
| FG001 | No Delirium | Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
9 participants who completed study procedures were excluded from analyses due to poor data quality.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Due to time constraints and limited availability of staff and the EEG technology, no participants completed both the pre-operative and post-operative EEG. Therefore, these data were not analyzed. | Posted | Data acquisition will occur on 4 separate days between postoperative days 1-8. |
|
4 visits over several weeks (up to 3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ben Palanca | Washington University School of Medicine Department of Anesthesiology | 314-273-9076 | palancab@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2019 | Feb 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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|
| fcDOT | Device | Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
|
|
| fcMRI | Device | Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
|
|
| Time Constraints |
|
| Conflict with care |
|
| Protocol Violation |
|
| MRI Incompatible |
|
| Patient Refusal |
|
| BG001 | No Delirium | Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | No Delirium | Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm EEG, fcDOT, fcMRI: Brain activity will be recorded using EEG, fcDOT and MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. |
|
| 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. | Due to the limited availability of staff and the DOT equipment, no participants completed both the pre-operative and post-operative DOT. Therefore, these data were not analyzed. | Posted | 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 | Nine participants (4 delirium, and 5 no delirium) who completed study procedures were excluded from analyses due to poor data quality or lack of post-operative delirium data. | Posted | Median | Inter-Quartile Range | r-value | Within one month after hospital discharge. |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | no Delirium | Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm fcMRI: Brain activity will be recorded using MRI to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients. | 2 | 33 | 0 | 33 | 0 | 33 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |