N/A
N=91
Postoperative Delirium: Brain Vulnerability and Recovery
Delirium · Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT03110185 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: EEG During Delirium and After Recovery and in Patient Controls.
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EEG (Device); fcDOT (Device); fcMRI (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EEG During Delirium and After Recovery and in Patient Controls. |
— | — |
| PRIMARY Functional Connectivity Diffuse Optical Tomography (fcDOT) in Patients During Delirium and After Recovery and in Patient Controls |
— | — |
| PRIMARY Functional Connectivity Magnetic Resonance Imaging (fcMRI) in Patients After Recovery From Delirium and in Patient Controls. |
0.1321; 0.1731 | 0.0761 |
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.
Eligibility Criteria
Common inclusion criteria:
- Age ≥ 60
- Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
- English speaking.
Common exclusion criteria:
- 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.
Data sourced from ClinicalTrials.gov (NCT03110185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.