Effectiveness of Electroencephalography Guided Anesthesia (EEG Anesthesia)
A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Ariel Clinical Research Coordinator Associate
- Numero di telefono: 650-724-3021
- Email: arielkay@stanford.edu
Backup dei contatti dello studio
- Nome: Maya Clinical Research Coordinator Associate
- Numero di telefono: 650-724-2620
- Email: mcaple@stanford.edu
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Comparatore attivo: Part A: Anesthesia Providers that Receive Training
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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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.
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Nessun intervento: Part A: Anesthesia Providers that Do Not Receive Training
Eligible anesthesia providers that include both anesthesiologists and CRNAs who will did not receive an EEG-guided anesthesia training program for anesthesia providers.
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Altro: Part B: All Participants Receive the EEG-Guided Intervention
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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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Minimum Alveolar Concentration (MAC)
Lasso di tempo: Intra-operative phase of care of participant.
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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.
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Intra-operative phase of care of participant.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Lasso di tempo: Postoperative Days 1 to 3.
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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.
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Postoperative Days 1 to 3.
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Collaboratori e investigatori
Sponsor
Sponsor
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Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 82323
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