Delirium, Postoperative Complications
Conditions
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.
Interventions
DEVICEEEG
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
DEVICEfcDOT
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
DEVICEfcMRI
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Controls | Data 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 |
Countries
United States
Participant flow
Recruitment details
Participants were either recruited pre- or post-operatively for study procedures depending on availability of equipment and research staff.
Pre-assignment details
Participants were not assigned to groups, as baseline delirium status determined which group the participants fell into (delirium vs. no delirium).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 28 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Conflict with care | 5 | 12 |
| Overall Study | Death | 0 | 1 |
| Overall Study | MRI Incompatible | 2 | 0 |
| Overall Study | Patient Refusal | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Time Constraints | 0 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 7 |
Baseline characteristics
| Characteristic | No Delirium | Total | Delirium |
|---|---|---|---|
| Age, Continuous | 68.5 years | 70 years | 74 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 41 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 40 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 25 Participants | 35 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 2 / 33 |
| other Total, other adverse events | 0 / 17 | 0 / 33 |
| serious Total, serious adverse events | 0 / 17 | 0 / 33 |
Outcome results
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.
Time frame: Data acquisition will occur on 4 separate days between postoperative days 1-8.
Population: 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.
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.
Time frame: Data acquisition will occur on 4 separate days between postoperative days 1-8.
Population: 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.
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
Time frame: Within one month after hospital discharge.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Delirium | Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls. | 0.1321 r-value |
| No Delirium | Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls. | 0.1731 r-value |
p-value: 0.0761Regression, Logistic