EEG Phase Synchrony, Sedation and Delirium in the CVICU

Delirium Clinical Trial

— SOS  

Official title:

EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04005196
• Other study ID #: 17-6037
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2019
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalography (EEG)	R-Index -- phase synchrony	Until ICU discharge; to a maximum 21 days
Secondary	CAM-ICU	q6 hours while in the ICU: delirium screen instrument	Until ICU discharge; to a maximum 21 days