EEG Guidance of Anesthesia (ENGAGES-CANADA) (ENGAGES)

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

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

Study Overview

• Status: Completed
• Conditions: Post-operative Delirium
• Intervention / Treatment: Procedure: EEG-Guided Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute, Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients will undergo standard anesthesia and will be blinded to EEG-based data, as per standard of care in this patient population.
Experimental: EEG-Guided Group; Practitioners will follow the EEG-Guided protocol to limit the incidence of EEG burst suppression by decreasing administration of anesthesia. The EEG-guided protocol is suggestive rather than prescriptive, and practitioners will exercise judgment depending on the clinical situation.	Procedure: EEG-Guided Group; Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: University of Washington; University of Toronto; Queen's University; Université de Montréal
• Investigators: Study Director: Eric Jacobsohn, MBChB FRCPC, University of Manitoa; Study Director: Michael Avidan, MBBCh FCASA, Washington University School of Medicine; Study Director: Tarit Saha, MD FRCPC, Queens University; Principal Investigator: Alain Deschamps, PhD MD FRCPC, Université de Montréal; Study Director: George Djaiani, MD, University of Toronto; Study Director: Renée El-Gabalawy, MA PhD, University of Manitoba

Publications and helpful links

General Publications

• Deschamps A, Saha T, El-Gabalawy R, Jacobsohn E, Overbeek C, Palermo J, Robichaud S, Dumont AA, Djaiani G, Carroll J, Kavosh MS, Tanzola R, Schmitt EM, Inouye SK, Oberhaus J, Mickle A, Ben Abdallah A, Avidan MS, Clinical Trials Group CPA. Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial. F1000Res. 2019 Jul 23;8:1165. doi: 10.12688/f1000research.19213.2. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2016
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimated): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; anesthesia; delirium; depression; surgery; anxiety; falls; electroencephalography; burst suppression
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: HS18290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO