ClinicalTrials.Veeva

Menu

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

U

University of Toronto

Status

Unknown

Conditions

Delirium

Treatments

Diagnostic Test: EEG

Study type

Observational

Funder types

Other

Identifiers

NCT04005196
17-6037

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems