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

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).

Condition or disease Intervention/treatment
Delirium Diagnostic Test: EEG

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Electroencephalography (EEG) [ Time Frame: Until ICU discharge; to a maximum 21 days ]
    R-Index -- phase synchrony

Secondary Outcome Measures :
  1. CAM-ICU [ Time Frame: Until ICU discharge; to a maximum 21 days ]
    q6 hours while in the ICU: delirium screen instrument

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT04005196

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Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Contact: Karolina Walczak, BA    416-603-5800 ext 6639   
Sponsors and Collaborators
University of Toronto
The Physicians' Services Incorporated Foundation
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Responsible Party: M. Elizabeth Wilcox, Assistant Professor, University of Toronto Identifier: NCT04005196    
Other Study ID Numbers: 17-6037
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders