- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04005196
EEG Phase Synchrony, Sedation and Delirium in the CVICU (SOS)
EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study
Study Overview
Detailed Description
Aim 1: To quantify EEG phase synchrony changes, both globally and locally by brain region, during emergence from medically induced coma required for performance of a cardiovascular related operation (deep sedation defined as a Riker Sedation-Agitation Scale [SAS] of 1-2).
Hypothesis: The global R-index will be increased above baseline at multiple frequency bandwidths and the magnitude of R-index will correlate with the sedative dosage (as a crude measure of depth). The rate of fluctuations of the R-index will decrease with deeper sedation.
Aim 2: To compare the magnitude of the EEG phase synchrony globally and locally in patients emerging from coma; a patient's pre-anesthesia phase will serve as a control.
Hypothesis: Fluctuations in R-index will vary; fluctuations will be greater in awake adults as compared to while comatose or emerging from coma.
Aim 3: To determine EEG phase synchrony changes in patients with and without delirium during their CVICU stay.
Hypothesis: Lower scores of R-index consistent with increased phase synchrony and lower spatio-temporal variability will be seen while delirious as compared to days when patients are not delirious.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network - Toronto General Hospital
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Contact:
- Karolina Walczak, BA
- Phone Number: 6639 416-603-5800
- Email: karolina.walczak@uhn.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Age 30 - 65 years
- Scheduled for first-time CABG or single valve replacement
Exclusion criteria:
- Previous stroke
- Severe pre-existing cognitive impairment (TICS score < 24)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalography (EEG)
Time Frame: Until ICU discharge; to a maximum 21 days
|
R-Index -- phase synchrony
|
Until ICU discharge; to a maximum 21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAM-ICU
Time Frame: Until ICU discharge; to a maximum 21 days
|
q6 hours while in the ICU: delirium screen instrument
|
Until ICU discharge; to a maximum 21 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-6037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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