EEG Guidance of Anesthesia (ENGAGES-CANADA)

Post-operative Delirium Clinical Trial

— ENGAGES  

Official title:

Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692300
• Other study ID #: HS18290
• Status: Completed
• Phase: N/A
• Start date: December 28, 2016
• Est. completion date: February 24, 2023

Study information

• Verified date: August 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the potential link between deep levels of anesthesia and delirium.

Description:

ENGAGES CANADA is a parallel study to the ENGAGES study which has been published in JAMA, DOI:10.1001/jama.2019.5161. Due to the difference in practice models and types of anesthesia principles, ENGAGES CANADA is an important study. Delirium is a relatively common postoperative complication in the geriatric population, affecting 20% to 70% of surgical patients over the age of 60. Delirium manifests as confusion, inattention and the inability to think logically, and may affect the patient's postoperative healing and rehabilitation. It is associated with persistent cognitive decline, longer hospital stay, increased incidence of injurious falls, and increased mortality. Patients undergoing major cardiac surgery are at a significant risk of postoperative delirium. To date, there is no proven method to prevent postoperative delirium in this patient population and often delirious events remain unrecognized. Randomized controlled studies in diverse surgical patient populations suggest that intraoperative electroencephalography (EEG) guidance during general anesthesia may decrease postoperative delirium and adverse postoperative outcomes. Patients who experience postoperative delirium report persistently decreased quality of life and it is a risk factor for incident psychiatric disorders and psychotropic medication use. One potential key mechanism in the relationship between delirium and incident psychiatric illness may be the experience of dissociation (disturbed awareness, impaired memory, or altered perceptions) in the perioperative period in those who are delirious. The co-occurrence of psychiatric illness and delirium can put older adults at greater risk of negative long terms effect such as functional decline. This study will compare the effectiveness of two anesthetic protocols in reducing postoperative delirium and postoperative health-related quality of life in a high risk population.We expect that EEG-guided anesthetic management of patients during their operative procedure will result in improved health-related outcomes, specifically decreased incidence of postoperative delirium and improved postoperative mental and physical health outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Adults 60 years or older;

2. Competent to provide informed consent;

3. Undergoing elective cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

1. Unable to provide informed consent;

2. Preoperative delirium;

3. Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;

4. History of intraoperative awareness

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Post-operative Delirium

Intervention

Procedure:
• EEG-Guided Group
Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE

Locations

Country	Name	City	State
Canada	Montreal Heart Institute, Université de Montréal	Montréal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
University of Manitoba	Queen's University, Université de Montréal, University of Toronto, University of Washington

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of falls at 30 days and 1 year	Number of falls will be recorded by patient interview at 30 days and 1 year, compared between the Control Group and the EEG-Guided Group.	30 days, 1 year
Other	Duration of delirium	Time (days) measured between the first and last positive CAM assessments and compared between the Control Group and the EEG-Guided Group.	5 days
Other	Severity of delirium	Severity of delirium will be compared between the Control Group and the EEG-Guided Group. As assessed by the CAM-S severity score	5 days
Other	Association between delirium and falls	The overall incidence of delirium as assessed by CAM vs the incidence of falls by an adjusted regression model.	30 days and 1 year
Other	Association between delirium and quality of life by PROMIS Global Health	The overall incidence of delirium as assessed by CAM vs quality of life as assessed by the PROMIS Global Health measure, by an adjusted regression model.	30 days and 1 year
Other	Predictors and outcomes of perioperative dissociation by PDEQ at 5 days and 30 days postoperatively.	A regression model will be used to assess independent predictors of dissociation as assessed by the PDEQ measure, and mental health outcomes associated with perioperative dissociation.	5 day and 30 days
Other	Predictors and outcomes of perioperative distress by PDI at 5 days and 30 days postoperatively	A regression model will be used to assess independent predictors of PTSD as assessed by the PDI measure.	5 days and 30 days
Other	Association between depth of anesthesia by EEG monitoring and mortality rate	Depth of anesthesia measured by BIS, Medline, or MASIMO monitors vs mortality rate by an adjusted regression model.	1 year
Other	Predictors of Post-Traumatic Stress Disorder (PTSD) using the Post-Traumatic Checklist for DSM-5 (PCL-5).	A regression model will be used to assess independent predictors of PTSD as assessed by the PCL-5 measure. This score predicts the risk of PTSD from 0, negligible risk, to 80, extremely high risk of PTSD in patients.	30 days and 1 year
Other	Incidence of major intraoperative and postoperative complications.	Undesirable intraoperative movement, awareness with recall, complications such as major blood loss and transfusions, stroke, sternal wound infection, sepsis, dialysis, prolonged intubation	Up to 30 days post surgery
Primary	Incidence of post-operative delirium	Incidence of delirium will be compared between the Control Group and the EEG-Guided Group as measured by the numbers of positive Confusion Assessment Method (CAM) or CAM for intensive care unit (CAM-ICU) scores, coupled with Chart Review.	5 days
Secondary	Incidence of mortality at 30 days and at 1 year	Incidence of mortality (%) will be compared between the Control Group and the EEG-Guided Group at 30 days and at 1 year	30 days, 1 year
Secondary	Length of ICU stay	Length of ICU stay (days) will be compared between the Control Group and the EEG-Guided Group.	Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year)
Secondary	Length of Hospital stay	Length of hospital stay (days) will be compared between the Control Group and the EEG-Guided Group.	Time (days) from admission to discharge from hospital (or through study completion at one year)