Effectiveness of Electroencephalography Guided Anesthesia

Official title

A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD

Overview

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

• Other EEG-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.
• Device EEG-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.

Primary outcome measures

• Minimum Alveolar Concentration (MAC) [Time frame: Intra-operative phase of care of participant.]

Secondary outcome measures (1)

• 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) [Time frame: Postoperative Days 1 to 3.]

Eligibility criteria

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.

Exclusion criteria

Part A Exclusion Criteria:

• Fellowship training in neuroanesthesia or neurocritical care.
• Participation in EEG-related research or formal EEG training within the past 12 months.
• Inability to access or utilize required technology (e.g., computer or tablet with internet access) necessary for completion of digital modules and online assessments.
• Any condition (physical, psychological, or cognitive) that, in the opinion of the site investigator, would preclude full participation in study activities or completion of the study protocol.
• Known allergy or sensitivity to materials used in EEG electrodes (e.g., adhesives or gels), if applicable.
• Non-practicing anesthetic providers (e.g., retired, not currently providing clinical care).

Part B Exclusion Criteria:

• Is unable to provide legally effective informed consent.
• Is scheduled for emergency, cardiac, or neurologic surgery.
• Has an American Society of Anesthesiologists (ASA) physical status of IV or greater.
• Has a pre-existing diagnosis of dementia, significant cognitive impairment, or other major neurologic disease (e.g., epilepsy, Parkinson's disease).
• Has a known allergy to the adhesives or gels used with EEG electrodes.
• Has a condition, such as a craniofacial deformity or skin condition on the forehead, that would prevent proper placement or functioning of the EEG monitor.
• Currently pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07567729 · 82323

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗