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| ID | Type | Description | Link |
|---|---|---|---|
| 1UH2AG050312-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study aims to determine whether, compared with usual anesthetic care, an electroencephalography-guided anesthesia protocol is effective at preventing postoperative delirium and its downstream effects, and improving postoperative patient reported health-related quality of life.
Delirium is one of several geriatric syndromes, and is among the most common postoperative complications, affecting up to 70% of surgical patients older than 60. Delirium is an acute change that manifests as inattention and inability to think logically, and is deeply distressing to patients and their families. Based on our surveys of 1,000 surgical patients, over 30% were worried about experiencing delirium. Delirious patients are unable to participate effectively in rehabilitation exercises and are susceptible to other geriatric syndromes, like falls. The occurrence and duration of delirium are associated with longer intensive care unit and hospital stay, persistent cognitive deterioration, hospital readmission and increased mortality rate. Additionally, delirium carries a huge social and economic burden, costing over $60,000 per patient per year. Despite the importance of delirium to patients and to society, no approach has been proven to prevent postoperative delirium. Furthermore postoperative delirium is frequently unrecognized, and surgical patients are not followed systematically after they are discharged from hospital. Without diagnosing delirium or following patients postoperatively, we are limited in our ability to test the effectiveness of any intervention to prevent or treat postoperative delirium and its sequelae. There is mounting evidence that electroencephalography guidance of general anesthesia can decrease postoperative delirium. Specifically, our group has found that a suppressed electroencephalogram pattern, which occurs with deep anesthesia, is associated with increased delirium and death after surgery. The Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study will therefore compare the effectiveness of two anesthetic protocols for reduction of postoperative delirium. One protocol will be based on current standard anesthetic practice, and the other protocol will be based on electroencephalography guidance. We also expect to determine the impact of the anesthetic protocols on patient reported outcomes of health-related quality of life. At Washington University, we have successfully implemented an ambitious study that enrolls patients at the preoperative assessment clinic, and tracks their health and wellbeing at 30 days and at 1-year postoperatively. This will enable us to assess the consequences of postoperative delirium and to determine whether anesthetic management can impact patient reported outcomes, such as health-related quality of life. We shall also explore whether a multi-component safety intervention for delirious patients prevents downstream adverse events, like falls. The ENGAGES study - through its structured anesthesia protocols, its thorough approach to delirium assessment, and its ability to track patients' health and wellbeing postoperatively - is poised to make a major contribution to the care of elderly patients who are at risk of postoperative delirium and other adverse outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEG guided protocol | Experimental | Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression. |
|
| Control Arm | No Intervention | Participants will have the standard anesthetic protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a pragmatic EEG-guided anesthetic protocol | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Delirium | Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Falls | The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Delirium | Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews. | 5 days |
| Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions |
Inclusion:
Exclusions
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| Name | Affiliation | Role |
|---|---|---|
| Michael S. Avidan, MBBCh, FCASA | Washington University School of Medicine | Principal Investigator |
| Eric Lenze, MD | Washington University School of Medicine | Study Director |
| Nan Lin, PhD | Washington University School of Medicine | Study Director |
| Susan Stark, PhD | Washington University School of Medicine | Study Director |
| Troy Wildes, MD | Washington University School of Medicine | Study Director |
| Anke Winter, MD | Washington University School of Medicine | Study Director |
| Sharon Inouye, MD | Hebrew Rehabilitation Center | Study Director |
| Arbi Ben Abdallah, PhD | Washington University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130079 | Derived | Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13. | |
| 34243940 | Derived | Fritz BA, King CR, Mickle AM, Wildes TS, Budelier TP, Oberhaus J, Park D, Maybrier HR, Ben Abdallah A, Kronzer A, McKinnon SL, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Stevens TW, Stark SL, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of electroencephalogram-guided anaesthesia administration on 1-yr mortality: follow-up of a randomised clinical trial. Br J Anaesth. 2021 Sep;127(3):386-395. doi: 10.1016/j.bja.2021.04.036. Epub 2021 Jul 7. |
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1400 participants were consented to the study168 were not randomized to a study treatment arm (2 died, 49 were ineligible after enrollment, 49 surgery was cancelled, 31 research team missed the surgery, 37 withdrew). A total of 1232 patients were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | EEG Guided Protocol | Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression. a pragmatic EEG-guided anesthetic protocol |
| FG001 | Control Arm | Participants will have the standard anesthetic protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EEG Guided Protocol | Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression. a pragmatic EEG-guided anesthetic protocol |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Delirium | Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five. | A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge). | Posted | Count of Participants | Participants | 5 days |
|
Adverse events were collected during surgery up to 30 days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EEG Guided Protocol | Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression. a pragmatic EEG-guided anesthetic protocol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/anemia requiring unexpected transfusion | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/anemia requiring unexpected transfusion | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Avidan, MBBCh | Washington University | 314-332-7265 | avidanm@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol with analysis plan | Dec 21, 2015 | Jun 21, 2019 | Prot_SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Updated Analysis plan for 1 year | Jun 21, 2019 | Jul 8, 2019 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Up to 1 year postoperatively |
| Health Related Quality of Life | The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year). | Up to one year postoperatively |
The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.
| 5 days |
| Duration or Recurrence of Delirium After Hospital Discharge | As measured by the FAM-CAM and patient perceptions | 30 days post discharge |
| Clinically Relevant Outcomes Associated With Delirium | Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline. | 1 year |
| Comparison of Patient-reported and Observational Pain Scores | Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients. | 5 days |
| Postoperative Actigraphy | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement. | 1 day |
| Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis. | 5 days |
| Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth | There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study. | 1 year |
| Delirium Prediction Models | It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group. | 5 days |
| Collaborations With Other Studies | The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites. | 5 years |
| Number of Participants With Severe Delirium | The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19). | 5 days |
| EEG and Delirium | EEG abnormalities have previously been associated with postoperative delirium | 5 days |
| Postoperative Actigraphy- Immobile Minutes | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile. | 1 day |
| 30721296 | Derived | Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005. |
| 30621829 | Derived | Maybrier HR, King CR, Crawford AE, Mickle AM, Emmert DA, Wildes TS, Avidan MS, Palanca BJA; ENGAGES Study Investigators. Early Postoperative Actigraphy Poorly Predicts Hypoactive Delirium. J Clin Sleep Med. 2019 Jan 15;15(1):79-87. doi: 10.5664/jcsm.7576. |
| 29550773 | Derived | Aranake-Chrisinger A, Cheng JZ, Muench MR, Tang R, Mickle A, Maybrier H, Lin N, Wildes T, Lenze E, Avidan MS. Ability of postoperative delirium to predict intermediate-term postoperative cognitive function in patients undergoing elective surgery at an academic medical centre: protocol for a prospective cohort study. BMJ Open. 2018 Mar 17;8(3):e017079. doi: 10.1136/bmjopen-2017-017079. |
| 29239943 | Derived | Mickle AM, Maybrier HR, Winter AC, McKinnon SL, Torres BA, Lin N, Lenze EJ, Stark S, Muench MR, Jacobsohn E, Inouye SK, Avidan MS, Wildes TS; ENGAGES Research Group*. Achieving Milestones as a Prerequisite for Proceeding With a Clinical Trial. Anesth Analg. 2018 Jun;126(6):1851-1858. doi: 10.1213/ANE.0000000000002680. |
| 28698343 | Derived | Cui V, Tedeschi CM, Kronzer VL, McKinnon SL, Avidan MS. Protocol for an observational study of delirium in the post-anaesthesia care unit (PACU) as a potential predictor of subsequent postoperative delirium. BMJ Open. 2017 Jul 10;7(7):e016402. doi: 10.1136/bmjopen-2017-016402. |
| 27311914 | Derived | Wildes TS, Winter AC, Maybrier HR, Mickle AM, Lenze EJ, Stark S, Lin N, Inouye SK, Schmitt EM, McKinnon SL, Muench MR, Murphy MR, Upadhyayula RT, Fritz BA, Escallier KE, Apakama GP, Emmert DA, Graetz TJ, Stevens TW, Palanca BJ, Hueneke R, Melby S, Torres B, Leung JM, Jacobsohn E, Avidan MS. Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial. BMJ Open. 2016 Jun 15;6(6):e011505. doi: 10.1136/bmjopen-2016-011505. |
| Control Arm |
Participants will have the standard anesthetic protocol. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Attended College | Count of Participants | Participants |
|
| Lifetime tobacco use | Count of Participants | Participants |
|
| Number of Participants with a Weekly Alcohol Intake | Count of Participants | Participants |
|
| Current use of anticonvulsants | Count of Participants | Participants |
|
| Regular use of opioids | Count of Participants | Participants |
|
| Regular use of benzodiazepine | Count of Participants | Participants |
|
| Number of participants with American Society of Anesthesiologist Classification greater than 3 | American Society of Anesthesiologist (ASA) Classification ASA I: Normal Healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: a patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| Marginal exercise tolerance (METs) less than 4 | The Functional status of the patient can be divided into POOR (< 4 METs,-unable to walk > 2 blocks on level ground without stopping due to symptoms, eating, dressing, toileting, walking indoors, light housework) or MODERATE /EXCELLENT (> 4 METs, -climbing > 1 flight of stairs without stopping, walking up hill > 1-2 blocks, scrubbing floors, moving furniture, golf, bowling, dancing or tennis, running short distance | Count of Participants | Participants |
|
| Pulmonary hypertension | Count of Participants | Participants |
|
| Aortic stenosis | Count of Participants | Participants |
|
| History or high risk OSA | Count of Participants | Participants |
|
| History of delirium | Count of Participants | Participants |
|
| Number of comorbidities | Median | Inter-Quartile Range | Number of comorbidities |
|
| History of depression | Count of Participants | Participants |
|
| Personal Health Questionnaire Depression Scale (PHQ-8) | Assesses current depression. Range 0 to 24. greater than or equal to 10 indicates major depression and greater than or equal to 20 indicates severe major depression. | Median | Inter-Quartile Range | units on a scale |
|
| Short Blessed Test (SBT) | The SBT is a screening tool that aids in detecting early cognitive changes associated with dementia disorders. Rage 0 to 28. A score of 0-4 is normal cognition, 5-9 is questionable cognitive impairment, 10 or greater is cognitive impairment consistent with dementia. | Median | Inter-Quartile Range | units on a scale |
|
| 8-item Inerview-Differentiate Aging and Dementia (AD8) | The AD8 is quite sensitive to detecting early cognitive changes associated many common dementing illness including Alzheimer disease, vascular dementia, Lewy body dementia and frontotemporal dementia. Range 0 to 8. A score of 0-1 is normal cognition, 2 or greater cognitive impairment is likely to be present. | Median | Inter-Quartile Range | units on a scale |
|
| Barthel Activies of Daily Living | Assesses functional independence. Range 0 to 100. Less than 20 indicates totally dependent, 20 to 39 indicates very dependent, 40-59 indicates partially dependent, 60 to 79 indicates minimally dependent, 80 to 100 indicates independent. | Median | Full Range | units on a scale |
|
| Hand grip strength | Mean | Standard Deviation | kg |
|
| Timed up and go | Median | Inter-Quartile Range | seconds |
|
| Lawton Instrumental Activities of Daily Living | Instrument assesses independent living skills. Range 0 (low function, dependent) to 8 (high function, independent). | Median | Inter-Quartile Range | units on a scale |
|
| Physical Veterans Rand 12 Item Health Survey (VR-12) Score | VR-12 is a patient reported global heath measure that is used to assess a patient's overall perspective of their health. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score which then provides an important contrast between the respondents physical and psychological health status. Standardized scale 0 to 100 with 50 representing the population average. A score above 50 is better than the USA average where a score below 50 is worse than the USA average. | Mean | Standard Deviation | Physical Score |
|
| Mental VR-12 score | VR-12 is a patient reported global heath measure that is used to assess a patient's overall perspective of their health. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score which then provides an important contrast between the respondents physical and psychological health status. Standardized scale 0 to 100 with 50 representing the population average. A score above 50 is better than the USA average where a score below 50 is worse than the USA average. | Mean | Standard Deviation | Mental Score |
|
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression. a pragmatic EEG-guided anesthetic protocol |
| OG001 | Control Arm | Participants will have the standard anesthetic protocol. |
|
|
| Secondary | Postoperative Falls | The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls. | Not Posted | Dec 2020 | Up to 1 year postoperatively | Participants |
| Secondary | Health Related Quality of Life | The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year). | Not Posted | Dec 2020 | Up to one year postoperatively | Participants |
| Other Pre-specified | Duration of Delirium | Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews. | A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge). | Posted | Median | Inter-Quartile Range | days | 5 days |
|
|
|
| Other Pre-specified | Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions | The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients. | Not Posted | Jul 2020 | 5 days | Participants |
| Other Pre-specified | Duration or Recurrence of Delirium After Hospital Discharge | As measured by the FAM-CAM and patient perceptions | Not Posted | Jul 2020 | 30 days post discharge | Participants |
| Other Pre-specified | Clinically Relevant Outcomes Associated With Delirium | Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline. | Not Posted | Dec 2020 | 1 year | Participants |
| Other Pre-specified | Comparison of Patient-reported and Observational Pain Scores | Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients. | Not Posted | Jul 2020 | 5 days | Participants |
| Other Pre-specified | Postoperative Actigraphy | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement. | A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients. | Posted | Median | Inter-Quartile Range | minutes RMSactivity>0 | 1 day |
|
|
|
| Other Pre-specified | Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments | Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis. | Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement. | Posted | Number | 95% Confidence Interval | Cohen's kappa coefficient | 5 days |
|
|
|
| Other Pre-specified | Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth | There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study. | Not Posted | Dec 2020 | 1 year | Participants |
| Other Pre-specified | Delirium Prediction Models | It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group. | Covariated included were pre-selected and considered likely to be associated with postoperative delirium. | Posted | Number | 95% Confidence Interval | odds ratio | 5 days |
|
|
|
| Other Pre-specified | Collaborations With Other Studies | The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites. | Not Posted | Jan 2025 | 5 years | Participants |
| Other Pre-specified | Number of Participants With Severe Delirium | The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19). | A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge). | Posted | Count of Participants | Participants | 5 days |
|
|
|
| Other Pre-specified | EEG and Delirium | EEG abnormalities have previously been associated with postoperative delirium | Not Posted | Jul 2020 | 5 days | Participants |
| Other Pre-specified | Postoperative Actigraphy- Immobile Minutes | Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile. | A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients. | Posted | Median | Inter-Quartile Range | minutes RMSactivity=0 | 1 day |
|
|
|
| 4 |
| 614 |
| 124 |
| 614 |
| 361 |
| 614 |
| EG001 | Control Arm | Participants will have the standard anesthetic protocol. | 20 | 618 | 130 | 618 | 345 | 618 |
| Embolus | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis without embolus | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other hematologic event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Unexpected atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Unexpected cardiogenic shock | Cardiac disorders | Systematic Assessment |
|
| Unexpected heart block | Cardiac disorders | Systematic Assessment |
|
| Other unexpected abnormal heart rhythms | Cardiac disorders | Systematic Assessment |
|
| Unexpected hypo or hyperkelemia | Endocrine disorders | Systematic Assessment |
|
| Unexpected hypo or hypernatremia | Endocrine disorders | Systematic Assessment |
|
| Other endocrine or metabolic event | Endocrine disorders | Systematic Assessment |
|
| Anastomotic leak | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus/bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Other GI event | Gastrointestinal disorders | Systematic Assessment |
|
| Anaphylaxis | Immune system disorders | Systematic Assessment |
|
| Infectious colitis | Immune system disorders | Systematic Assessment |
|
| Sepsis | Immune system disorders | Systematic Assessment |
|
| UTI | Immune system disorders | Systematic Assessment |
|
| Wound infection | Immune system disorders | Systematic Assessment |
|
| Other immune or infectious event | Immune system disorders | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Other neurological event | Nervous system disorders | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failures | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other respiratory event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure requiring dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Other renal event | Renal and urinary disorders | Systematic Assessment |
|
| Non-cardiogenic shock | Vascular disorders | Systematic Assessment |
|
| Unexpected hypotension | Vascular disorders | Systematic Assessment |
|
| Other vascular event | Vascular disorders | Systematic Assessment |
|
| Other body system event | Surgical and medical procedures | Systematic Assessment |
|
| Embolus | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombosis without embolus | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other hematologic event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Unexpected atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Unexpected cardiogenic shock | Cardiac disorders | Systematic Assessment |
|
| Unexpected heart block | Cardiac disorders | Systematic Assessment |
|
| Other unexpected abnormal heart rhythms | Cardiac disorders | Systematic Assessment |
|
| Other cardiac event | Cardiac disorders | Systematic Assessment |
|
| unexpected hypo or hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Unexpected hypo or hyperkalemia | Endocrine disorders | Systematic Assessment |
|
| Unexpected hypo or hypernatremia | Endocrine disorders | Systematic Assessment |
|
| Other endocrine event | Endocrine disorders | Systematic Assessment |
|
| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus/bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Other GI event | Gastrointestinal disorders | Systematic Assessment |
|
| Infectious colitis | Immune system disorders | Systematic Assessment |
|
| Non-anaphylactic allergic reaction | Immune system disorders | Systematic Assessment |
|
| Sepsis | Immune system disorders | Systematic Assessment |
|
| UTI | Immune system disorders | Systematic Assessment |
|
| Wound infection | Immune system disorders | Systematic Assessment |
|
| Other immune event | Immune system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Other neurological event | Nervous system disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failures | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other respiratory event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure requiring dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Other renal event | Renal and urinary disorders | Systematic Assessment |
|
| Non-cardiogenic shock | Cardiac disorders | Systematic Assessment |
|
| Unexpected hypertension | Vascular disorders | Systematic Assessment |
|
| Unexpected hypotension | Vascular disorders | Systematic Assessment |
|
| Other vascular event | Vascular disorders | Systematic Assessment |
|
| Other body system event | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| White |
|
| Living alone |
|
| Hearing aid use |
|
| No. Comorbidities |
|
| ASA greater than 3 |
|
| Marginal exercise tolerance less than 4 METS |
|
| Falls in previous 6 months |
|
| History of delirium |
|
| Preoperative PHQ8 |
|
| Preoperative Lawton |
|
| Preoperative Barthel |
|
| Preoperative opioids |
|
| Preoperative benzodiazepines |
|
| Preoperative sodium level |
|
| Preoperative creatinine level |
|
| Preoperative hemoglobin level |
|
| Cardiac surgery |
|