Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study
Phase: NA
Conditions: Delirium
Sponsor: Washington University School of Medicine



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o
Method of measurement: Veteran’s RAND 12

≤
≤
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Strengths
Limitations
guided anesthetic protocol will depend on clinicians’

hospital delirium occurs, patients’

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Research Design Overview (See Figure 2)
Study Subjects
Recruitment

pilot cohort, practical aspects of the trial’s conduct will be evaluated. These include the feasibility of enrolling
Randomization and Blinding
sequence generated by one of the study’s data analysts.
Primary Intervention – EEG-guided Anesthetic Protocol

or at the clinician’s discretion

Ensure practitioner fidelity to the EEG-guided protocol
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titled “EEG Waveforms and Depth of Anesthesia”
Secondary Intervention – Multi-Component Safety Intervention

that patients’ families exercise
Data Collection
hospital’s
i
soft®
Cognitive Testing

Patients’ Postoperative Health and Wellbeing
Outcome Measures
i) Incidence of Postoperative Delirium (Aim 1 in Figure 2)

ii) Health-related Quality of Life (Aims 2 and 3 in Figure 2)
be assessed through the Veteran’s RAND 12
iii) Falls (Aims 2 and 3 in Figure 2)
Pre-specified additional analyses and sub-studies

Patient Centered Approach
Statistical Analyses
i) Effectiveness of EEG-guided anesthesia protocol in reducing incident postoperative delirium compared with
usual anesthetic care (Aim 1 in Figure 2)
and ≥70
ii) Effectiveness of EEG-guided anesthesia protocol in improving patient reported outcomes of health-related
quality of life and preventing postoperative falls (Aim 2 in Figure 2)
= α + β t + β
+ β
t + β
~ N(0, σ ) β
between the Intervention and usual care groups. The coefficient β
cores between groups at baseline. The coefficient β
iii) Explore whether a multi-component safety intervention is associated with improved patient reported health-
related quality of life and decreased incidence of postoperative falls (Aim 3 in Figure 2)

Sample Size Calculations
i) Decrease in Delirium
% power to detect an absolute decrease in delirium incidence ≥
incidence ≥8%, and >80% power to detect a decrease in delirium incidence ≥7%.
ii) Health Related Quality of Life
iii) Postoperative Falls
Analysis of Pragmatic Elements of the ENGAGES Study
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protocol (i.e. it will be an “intention
treat” analysis). The analysis will attempt to
Strengths and Limitations

ans’ adherence to the
Potential Benefits, Risks and Alternatives
Benefits

research protection office and to the study’s data safety monitoring board. Participants will not incur any study
Minimization of Risks and Confidentiality
Adverse Event Reporting and Safety Monitoring

Premature Study Termination
Indemnity

Duration and Severity of Delirium
b) Agreements among the FAM-CAM, researchers’ delirium assessments and patient perceptions
CAM assessments and the patients’ self
assessments will be compared with the researchers’ delirium assessments.
c) Duration or recurrence of delirium after hospital discharge as measured by the FAM-CAM and patient
perceptions
d) Clinically relevant outcomes associated with delirium
e) Comparison of patient-reported and observational pain scores

h) Association Between Delirium and Patient Outcomes
i)
Postoperative outcomes hypothesized to be associated with anesthetic depth
j)
Delirium Prediction Models
Charlson Comorbidity Index, American Society of Anesthesiologists’ Physical Status, functional status,