RecruitingNCT03124303
Interventions for Postoperative Delirium: Biomarker-3
Sponsor
University of Wisconsin, Madison
Enrollment
468 participants
Start Date
Feb 13, 2017
Study Type
OBSERVATIONAL
Conditions
Summary
The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.
Eligibility
Min Age: 60 Years
Inclusion Criteria4
- Cohort 1: Age ≥65 years
- Cohort 2: Age ≥60 years
- Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
- Written Informed Consent for potential participation prior to surgery
Exclusion Criteria9
- Contraindication to EEG
- Unable or unwilling to attend the follow-up appointments
- Documented history of dementia
- Deemed incapable of providing consent by surgical team
- Residing in a nursing home
- Undergoing intracranial surgery
- Unable to complete neurocognitive testing due to language, vision or hearing impairment
- Unable to communicate with the research staff due to language barriers
- For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)
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Interventions
PROCEDUREHigh Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
PROCEDUREMagnetic Resonance Imaging
MRI scan of brain
PROCEDUREBlood specimen collection
Blood will be collected from participants
DIAGNOSTIC_TESTPupillometry
A pupillometer is a device that measures the size of the pupils.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03124303
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