EEG Guidance of Anesthesia (ENGAGES-CANADA)
Study Details
Study Description
Brief Summary
This study examines the potential link between deep levels of anesthesia and delirium.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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. |
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| 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of post-operative delirium [5 days]
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.
Secondary Outcome Measures
- Incidence of mortality at 30 days and at 1 year [30 days, 1 year]
Incidence of mortality (%) will be compared between the Control Group and the EEG-Guided Group at 30 days and at 1 year
- Length of ICU stay [Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year)]
Length of ICU stay (days) will be compared between the Control Group and the EEG-Guided Group.
- Length of Hospital stay [Time (days) from admission to discharge from hospital (or through study completion at one year)]
Length of hospital stay (days) will be compared between the Control Group and the EEG-Guided Group.
Other Outcome Measures
- Incidence of falls at 30 days and 1 year [30 days, 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.
- Duration of delirium [5 days]
Time (days) measured between the first and last positive CAM assessments and compared between the Control Group and the EEG-Guided Group.
- Severity of delirium [5 days]
Severity of delirium will be compared between the Control Group and the EEG-Guided Group. As assessed by the CAM-S severity score
- Association between delirium and falls [30 days and 1 year]
The overall incidence of delirium as assessed by CAM vs the incidence of falls by an adjusted regression model.
- Association between delirium and quality of life by PROMIS Global Health [30 days and 1 year]
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.
- Predictors and outcomes of perioperative dissociation by PDEQ at 5 days and 30 days postoperatively. [5 day and 30 days]
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.
- Predictors and outcomes of perioperative distress by PDI at 5 days and 30 days postoperatively [5 days and 30 days]
A regression model will be used to assess independent predictors of PTSD as assessed by the PDI measure.
- Association between depth of anesthesia by EEG monitoring and mortality rate [1 year]
Depth of anesthesia measured by BIS, Medline, or MASIMO monitors vs mortality rate by an adjusted regression model.
- Predictors of Post-Traumatic Stress Disorder (PTSD) using the Post-Traumatic Checklist for DSM-5 (PCL-5). [30 days and 1 year]
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.
- Incidence of major intraoperative and postoperative complications. [Up to 30 days post surgery]
Undesirable intraoperative movement, awareness with recall, complications such as major blood loss and transfusions, stroke, sternal wound infection, sepsis, dialysis, prolonged intubation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults 60 years or older;
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Competent to provide informed consent;
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Undergoing elective cardiac surgery requiring cardiopulmonary bypass.
Exclusion Criteria:
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Unable to provide informed consent;
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Preoperative delirium;
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Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;
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History of intraoperative awareness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montreal Heart Institute, Université de Montréal | Montréal | Quebec | Canada | H1T 1C8 |
Sponsors and Collaborators
- University of Manitoba
- Queen's University
- University of Washington
- University of Toronto
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS18290