Electroencephalography Guidance of Anesthesia (ENGAGES)
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|ClinicalTrials.gov Identifier: NCT02241655|
Recruitment Status : Unknown
Verified July 2019 by Michael Avidan, Washington University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2014
Results First Posted : June 18, 2019
Last Update Posted : July 30, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Delirium||Device: a pragmatic EEG-guided anesthetic protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2020|
Experimental: 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.
Device: a pragmatic EEG-guided anesthetic protocol
Other Name: Bispectral Index proprietary processed EEG monitor
No Intervention: Control Arm
Participants will have the standard anesthetic protocol.
- Number of Participants With Delirium [ Time Frame: 5 days ]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.
- Postoperative Falls [ Time Frame: Up to 1 year postoperatively ]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.
- Health Related Quality of Life [ Time Frame: Up to one year postoperatively ]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).
- Duration of Delirium [ Time Frame: 5 days ]Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.
- Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions [ Time Frame: 5 days ]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.
- Duration or Recurrence of Delirium After Hospital Discharge [ Time Frame: 30 days post discharge ]As measured by the FAM-CAM and patient perceptions
- Clinically Relevant Outcomes Associated With Delirium [ Time Frame: 1 year ]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.
- Comparison of Patient-reported and Observational Pain Scores [ Time Frame: 5 days ]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.
- Postoperative Actigraphy [ Time Frame: 1 day ]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.
- Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments [ Time Frame: 5 days ]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.
- Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth [ Time Frame: 1 year ]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.
- Delirium Prediction Models [ Time Frame: 5 days ]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.
- Collaborations With Other Studies [ Time Frame: 5 years ]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.
- Number of Participants With Severe Delirium [ Time Frame: 5 days ]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).
- EEG and Delirium [ Time Frame: 5 days ]EEG abnormalities have previously been associated with postoperative delirium
- Postoperative Actigraphy- Immobile Minutes [ Time Frame: 1 day ]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.
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|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients 60 years old and older,
- Competent to provide informed consent
- Undergoing major elective surgery that requires a minimum stay of 2 days postoperatively (e.g., open cardiac surgery, open thoracic surgery, major vascular surgery, intra-abdominal surgery, open gynecologic surgery, open urologic surgery, major orthopedic surgery, open hepato-biliary surgery and major ear, nose and throat surgery)
- Neurosurgical procedures will be excluded as surgery on the brain can confound the outcome (postoperative delirium).
- Patients with preoperative delirium and patients who are unable to participate adequately in delirium screening including those who are blind, deaf, or illiterate or fluent in languages other than English.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241655
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Michael S. Avidan, MBBCh, FCASA||Washington University School of Medicine|
|Study Director:||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|
Documents provided by Michael Avidan, Washington University School of Medicine:
|Responsible Party:||Michael Avidan, Professor of Anesthesiology, Washington University School of Medicine|
|Other Study ID Numbers:||
1UH2AG050312-01 ( U.S. NIH Grant/Contract )
|First Posted:||September 16, 2014 Key Record Dates|
|Results First Posted:||June 18, 2019|
|Last Update Posted:||July 30, 2019|
|Last Verified:||July 2019|
Health related quality of life
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