Clinical trial NCT04005196: EEG Phase Synchrony, Sedation and Delirium in the CVICU
Official title: EEG Phase SynchrOny, Sedation and Delirium in the CVICU - The SOS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2019-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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)

Primary outcomes:
measure: Electroencephalography (EEG)
timeFrame: Until ICU discharge; to a maximum 21 days
Secondary outcomes:
measure: CAM-ICU
timeFrame: Until ICU discharge; to a maximum 21 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
Study officials:
References: