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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Anesthesia Providers that Receive Training | Active Comparator | Eligible anesthesia providers that include both anesthesiologists and CRNAs who will receive an EEG-guided anesthesia training program for anesthesia providers. |
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| Part A: Anesthesia Providers that Do Not Receive Training | No Intervention | Eligible anesthesia providers that include both anesthesiologists and CRNAs who will did not receive an EEG-guided anesthesia training program for anesthesia providers. | |
| Part B: All Participants Receive the EEG-Guided Intervention | Other | 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 to remain unaware of specific details of the patient's anesthetic course. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG-guided anesthesia training program for anesthesia providers | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Alveolar Concentration (MAC) | 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. | Intra-operative phase of care of participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) | 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. | Postoperative Days 1 to 3. |
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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:
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:
Exclusion Criteria:
Part A Exclusion Criteria:
Part B Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Clinical Research Coordinator Associate | Contact | 650-724-2620 | mcaple@stanford.edu | |
| Ariel Clinical Research Coordinator Associate | Contact | 650-724-3021 | arielkay@stanford.edu |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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.
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| EEG-Guided Intervention | Device | 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. |
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |