Post-operative DeliriumENGAGESNCT02692300
EEG Guidance of Anesthesia (ENGAGES-CANADA)
A study testing EEG-Guided Group in people with Post-operative Delirium, run by University of Manitoba at 1 site in Canada.
Trial summary
This study examines the potential link between deep levels of anesthesia and delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Post-operative Delirium
- What is being tested?
- EEG-Guided Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,225 participants
- Where
- 1 siteCanada
- Study dates
- 28 Dec 2016to 24 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 60 years or older;
- Competent to provide informed consent;
- Undergoing elective cardiac surgery requiring cardiopulmonary bypass.
Who cannot join
- Unable to provide informed consent;
- Preoperative delirium;
- Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;
- History of intraoperative awareness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Heart Institute, Université de Montréal
Montreal, Quebec, H1T 1C8
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-operative Delirium
- Being tested
- EEG-Guided Group
- Keywords
- anesthesia, delirium, surgery, electroencephalography, burst suppression, PTSD, anxiety, depression, falls
- Medical subject headings
- Emergence Delirium, Delirium, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-Guided GroupProcedure or surgery
Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients will undergo standard anesthesia and will be blinded to EEG-based data, as per standard of care in this patient population. |
| EEG-Guided Group | Experimental | 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. Receives: Procedure: EEG-Guided Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Time (days) from admission to discharge from hospital (or through study completion at one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start28 Dec 2016
- Primary completion24 Feb 2022
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, University of Washington, University of Toronto, Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Eric Jacobsohn, MBChB FRCPC, Study director, University of ManitoaMichael Avidan, MBBCh FCASA, Study director, Washington University School of MedicineTarit Saha, MD FRCPC, Study director, Queens UniversityAlain Deschamps, PhD MD FRCPC, Principal investigator, Université de MontréalGeorge Djaiani, MD, Study director, University of TorontoRenée El-Gabalawy, MA PhD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692300
- Sponsor's protocol ID
- HS18290
- Acronym
- ENGAGES
- Status last verified
- Aug 2023
- First submitted
- 2 Feb 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Deschamps A, Ben Abdallah A, Jacobsohn E, Saha T, Djaiani G, El-Gabalawy R, Overbeek C, Palermo J, Courbe A, Cloutier I, Tanzola R, Kronzer A, Fritz BA, Schmitt EM, Inouye SK, Avidan MS; Canadian Perioperative Anesthesia Clinical Trials Group. Electroencephalography-Guided Anesthesia and Delirium in Older Adults After Cardiac Surgery: The ENGAGES-Canada Randomized Clinical Trial. JAMA. 2024 Jul 9;332(2):112-123. doi: 10.1001/jama.2024.8144.
PubMed 38857019Deschamps 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.
PubMed 31588356
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02692300
- Acronym / sponsor ID
- ENGAGES / HS18290
- Conditions
- Post-operative Delirium
- Keywords
- anesthesia, delirium, surgery, electroencephalography, burst suppression, PTSD, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Queen's University, University of Washington, University of Toronto, Université de Montréal
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the potential link between deep levels of anesthesia and delirium.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients will undergo standard anesthesia and will be blinded to EEG-based data, as per standard of care in this patient population. |
| EEG-Guided Group | Experimental | Procedure: EEG-Guided GroupPractitioners 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 60 years or older;
- Competent to provide informed consent;
- Undergoing elective cardiac surgery requiring cardiopulmonary bypass.
Key exclusion criteria (4 listed)
- Unable to provide informed consent;
- Preoperative delirium;
- Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;
- History of intraoperative awareness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-Guided GroupDevice: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE | Procedure or surgery | EEG-Guided Group |
Primary outcome
Incidence of post-operative delirium
Time frame: 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.
3 secondary outcomes
Incidence of mortality at 30 days and at 1 year
Time frame: 30 days, 1 year
Length of ICU stay
Time frame: Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year)
Length of Hospital stay
Time frame: Time (days) from admission to discharge from hospital (or through study completion at one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 38857019Deschamps A, Ben Abdallah A, Jacobsohn E, Saha T, Djaiani G, El-Gabalawy R, Overbeek C, Palermo J, Courbe A, Cloutier I, Tanzola R, Kronzer A, Fritz BA, Schmitt EM, Inouye SK, Avidan MS; Canadian Perioperative Anesthesia Clinical Trials Group. Electroencephalography-Guided Anesthesia and Delirium in Older Adults After Cardiac Surgery: The ENGAGES-Canada Randomized Clinical Trial. JAMA. 2024 Jul 9;332(2):112-123. doi: 10.1001/jama.2024.8144.
- Derived from this study: PubMed 31588356Deschamps 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jacobsohn, MBChB FRCPC study director
University of Manitoa
Michael Avidan, MBBCh FCASA study director
Washington University School of Medicine
Tarit Saha, MD FRCPC study director
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-Guided Group in people with Post-operative Delirium, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-operative delirium (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.