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EEG Phase Synchrony, Sedation and Delirium in the CVICU (SOS)
| 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 |
| 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 |
- 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
| 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 |
Electroencephalography (EEG) [ Time Frame: Until ICU discharge; to a maximum 21 days ] R-Index -- phase synchrony
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
CAM-ICU [ Time Frame: Until ICU discharge; to a maximum 21 days ] q6 hours while in the ICU: delirium screen instrument
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
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:
Exclusion criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||
