EEG Phase Synchrony, Sedation and Delirium in the CVICU

NCT04005196 | Unknown

• 1 other identifier: 17-6037
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Electroencephalography (EEG)

  R-Index -- phase synchrony

  Until ICU discharge; to a maximum 21 days

Secondary Outcomes (1)

• CAM-ICU

  Until ICU discharge; to a maximum 21 days

Interventions

EEG DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age 30 - 65 years
• Scheduled for first-time CABG or single valve replacement

You may not qualify if:

• Previous stroke
• Severe pre-existing cognitive impairment (TICS score \< 24)

Sponsors & Collaborators

• University of Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Delirium

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 30, 2019
• First Posted: July 2, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 2, 2019

Record last verified: 2019-07

Locations

CA (1)