EEG Phase Synchrony, Sedation and Delirium in the CVICU

NCT ID: NCT04005196

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-06-01

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.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

M. Elizabeth Wilcox

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Facility Contacts

Karolina Walczak, BA

Role: primary

karolina.walczak@uhn.ca

416-603-5800 ext. 6639

Other Identifiers

17-6037

Identifier Type: -

Identifier Source: org_study_id