Trial Outcomes & Findings for Postoperative Delirium: Brain Vulnerability and Recovery (NCT NCT03110185)
NCT ID: NCT03110185
Last Updated: 2020-06-02
Results Overview
Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms.
COMPLETED
NA
91 participants
Data acquisition will occur on 4 separate days between postoperative days 1-8.
2020-06-02
Participant Flow
Participants were either recruited pre- or post-operatively for study procedures depending on availability of equipment and research staff.
Participants were not assigned to groups, as baseline delirium status determined which group the participants fell into (delirium vs. no delirium).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
64
|
|
Overall Study
COMPLETED
|
17
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
31
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
|
Overall Study
Time Constraints
|
0
|
6
|
|
Overall Study
Conflict with care
|
5
|
12
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
MRI Incompatible
|
2
|
0
|
|
Overall Study
Patient Refusal
|
0
|
1
|
Baseline Characteristics
Postoperative Delirium: Brain Vulnerability and Recovery
Baseline characteristics by cohort
| Measure |
Delirium
n=13 Participants
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.
|
No Delirium
n=28 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=93 Participants
|
68.5 years
n=4 Participants
|
70 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Delta (0.5-4 Hz), theta (4-8 Hz), and alpha (8-12 Hz) EEG waveforms.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Functional connectivity between anterior and posterior Default Mode Network regions using diffuse optical imaging.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Delirium
n=13 Participants
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.
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.
|
No Delirium
n=28 Participants
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.
|
|---|---|---|
|
Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls.
|
0.1321 r-value
Interval 0.008 to 0.2562
|
0.1731 r-value
Interval 0.1048 to 0.2414
|
Adverse Events
Delirium
no Delirium
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ben Palanca
Washington University School of Medicine Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place