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EEG Phase Synchrony, Sedation and Delirium in the CVICU (SOS)

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ClinicalTrials.gov Identifier: NCT04005196
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
M. Elizabeth Wilcox, University of Toronto

Tracking Information
First Submitted Date June 30, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
Electroencephalography (EEG) [ Time Frame: Until ICU discharge; to a maximum 21 days ]
R-Index -- phase synchrony
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
CAM-ICU [ Time Frame: Until ICU discharge; to a maximum 21 days ]
q6 hours while in the ICU: delirium screen instrument
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EEG Phase Synchrony, Sedation and Delirium in the CVICU
Official Title EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study
Brief Summary EEG phase synchrony and variability has had limited investigation during transition from coma to wakefulness in response to sedation and analgesia. Studying changes in phase synchrony and variability during and after sedative-induced coma is an exciting opportunity to better understand EEG changes during transitions in states of arousal. It is expected that consciousness should be higher in entropy and greater in complexity in the number of configurations of pairwise connections as compared to sedative-induced coma. If sufficiently sensitive, it may be possible to identify states of lower entropy and fewer configurations when patient are aroused but with altered sensorium (e.g. delirium).
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Population: Adults aged 30 - 65 years, invasively mechanically ventilated for a first-time CABG or single valve replacement surgery; Exposure: R-index measured at different states of consciousness (awake, emerging from comatosed state, and transitional states between) after standardized induction with opioid and benzodiazepine with or without propofol; postoperative sedation in CVICU with propofol or other; Outcome: Delirium as measured by the Confusion Assessment Method-ICU (CAM-ICU).
Condition Delirium
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005196
Other Study ID Numbers 17-6037
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party M. Elizabeth Wilcox, University of Toronto
Study Sponsor University of Toronto
Collaborators The Physicians' Services Incorporated Foundation
Investigators Not Provided
PRS Account University of Toronto
Verification Date July 2019