EEG Phase Synchrony, Sedation and Delirium in the CVICU (SOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04005196|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment|
|Delirium||Diagnostic Test: EEG|
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 :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
- Diagnostic Test: EEG
Data recording will continue up until a maximum of 120 hours after emergence from sedation or at CVICU discharge. This study period is informed by baseline data from our institution where the median duration of delirium following emergence from coma was 2 days, allowing sufficient time to capture transitions from coma to wakefulness with and without delirium. EEG recordings will be divided in to epochs corresponding to coma, wakefulness, and delirium if present.
- Electroencephalography (EEG) [ Time Frame: Until ICU discharge; to a maximum 21 days ]R-Index -- phase synchrony
- CAM-ICU [ Time Frame: Until ICU discharge; to a maximum 21 days ]q6 hours while in the ICU: delirium screen instrument
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005196
|University Health Network - Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Karolina Walczak, BA 416-603-5800 ext 6639 email@example.com|