Electroencephalography Guidance of Anesthesia (ENGAGES)
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|ClinicalTrials.gov Identifier: NCT02241655|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2014
Last Update Posted : May 22, 2018
|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.
- Delirium [ Time Frame: 5 days ]Delirium will be assessed at baseline and then once a day postoperative for up to 5 days.
- 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 and Severity of 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.
- 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 and EEG [ Time Frame: 1 day ]Postoperative disturbances in sleep and EEG abnormalities have previously been associated with postoperative delirium.
- 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 between these routine clinical assessments and the assessments made by the research team.
- 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.
- 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.
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|