Delirium - Postoperative
Conditions
Brief summary
This study will use brain wave information, known as electroencephalography (EEG), to help guide anesthesia delivery during surgery. It is believed that the use of EEG has the potential to reduce postoperative delirium - a common side effect of general anesthesia. Postoperative delirium is known to cause long lasting cognitive deficits and increase the chance of developing dementia in geriatric patients. This study aims to reduce these risks posed by modern day anesthesia practices through more efficient delivery of anesthesia utilizing brain wave activity information.
Interventions
OTHEREEG-guided anesthesia training program for anesthesia providers
The EEG-guided anesthesia training session for the anesthesia providers will administer simulation-based assessments at baseline, immediately post-intervention, and at one, three, and six month follow-up time points to track provider competency in EEG interpretation and anesthetic titration.
DEVICEEEG-Guided Intervention
All surgical patients in Part B of the study will receive EEG-guided anesthesia. EEG data collected from patient participants will be provided as live data during their surgical procedures to the anesthesia provider. Anesthesia providers may use this data to assist their decision-making on anesthetic delivery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
In Part A, researchers will be identifying eligible anesthesia providers that include both anesthesiologists and CRNAs via institutional rosters at Stanford Medical Center. Once enrollment is complete, an independent statistician will begin the randomization of participants into the intervention (training) or control (no training) groups using "computer-generated sequence stratified by participant years (\<10 years, 10-30 years, \>30 years) to ensure balanced allocation. Part B will be a prospective, single-arm pilot study. As a result, randomization of patients into different groups will not occur, and all patients will receive the EEG-guided intervention. Blinding of the intraoperative clinical team is also not feasible in this case, as providers must be aware of all monitoring tools in use. Instead, this study will mitigate potential for bias by utilizing blinded outcome assessors. Researchers will be kept separate from the intraoperative care team.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part A Inclusion Criteria: * Signed and dated informed consent form prior to any study-specific procedures. * Willingness and ability to comply with all study procedures and availability for the duration of the study, including all scheduled assessments and follow-up visits. * Currently practicing anesthetic provider, defined as either: * Attending anesthesiologist, or * Certified Registered Nurse Anesthetist (CRNA). * Limited prior formal training in EEG interpretation for anesthetic depth, as self-reported by the participant (see
Exclusion criteria
for details). * Fluent in English, to ensure comprehension of study materials and assessments. * Able to access and utilize required technology (e.g., computer or tablet with internet access) for completion of digital modules and online assessments. * In good general health and capable of fulfilling clinical duties, as self-reported and confirmed by site investigator review. * Willingness to be randomized to any of the study arms and to participate in all assigned educational interventions and assessments. * Willingness to adhere to the protocol-specified anesthetic management strategy during the real-case assessments. Part B Inclusion Criteria: * Provides written, signed informed consent prior to the surgical procedure. * Is age 60 years or older. * Is scheduled to undergo an elective, non-cardiac, non-neurologic surgical procedure expected to last at least two hours. * Is planned to receive general anesthesia. * Has an American Society of Anesthesiologists (ASA) physical status of I, II, or III. * Has intact skin on the forehead suitable for the application of EEG electrodes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Alveolar Concentration (MAC) | Intra-operative phase of care of participant. | The primary endpoint is the total intraoperative anesthetic exposure. This will be measured as the time-weighted average of the age-adjusted Minimum Alveolar Concentration (MAC) of volatile anesthetic administered during the maintenance phase of anesthesia. These data will be collected directly from the electronic anesthetic record for each enrolled patient case and will be reviewed and verified by the study team. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) | Postoperative Days 1 to 3. | To gather data for POD progression modeling, patients will be assessed for delirium daily for the first three postoperative days using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). These assessments will be performed by trained research staff who are blinded to the patient's treatment group. |
Contacts
CONTACTMaya Clinical Research Coordinator Associate
CONTACTAriel Clinical Research Coordinator Associate
Outcome results
None listed