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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
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delirium Device: a pragmatic EEG-guided anesthetic protocol Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Delirium [ Time Frame: 5 days ]
    Delirium will be assessed at baseline and then once a day postoperative for up to 5 days.


Secondary Outcome Measures :
  1. 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.

  2. 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).


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Duration or recurrence of delirium after hospital discharge [ Time Frame: 30 days post discharge ]
    As measured by the FAM-CAM and patient perceptions

  4. 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.

  5. 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.

  6. Postoperative actigraphy and EEG [ Time Frame: 1 day ]
    Postoperative disturbances in sleep and EEG abnormalities have previously been associated with postoperative delirium.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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)

Exclusions

  • 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.

Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute on Aging (NIA)
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Avidan, Professor of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02241655     History of Changes
Other Study ID Numbers: 201407128
1UH2AG050312-01 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by Michael Avidan, Washington University School of Medicine:
Anesthesia
Electroencephalography
Burst suppression
Surgery
Delirium
Falls
Health related quality of life

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs