- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07567729
Effectiveness of Electroencephalography Guided Anesthesia (EEG Anesthesia)
30. april 2026 opdateret af: David R. Drover, Stanford University
A Pilot Study to Evaluate the Feasibility of EEG-guided Anesthesia Protocol to Reduce POD
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
225
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ariel Clinical Research Coordinator Associate
- Telefonnummer: 650-724-3021
- E-mail: arielkay@stanford.edu
Undersøgelse Kontakt Backup
- Navn: Maya Clinical Research Coordinator Associate
- Telefonnummer: 650-724-2620
- E-mail: mcaple@stanford.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Ingen indgriben: 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.
|
|
|
Andet: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Minimum Alveolar Concentration (MAC)
Tidsramme: 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.
|
Intra-operative phase of care of participant.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Tidsramme: 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.
|
Postoperative Days 1 to 3.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. januar 2031
Datoer for studieregistrering
Først indsendt
24. april 2026
Først indsendt, der opfyldte QC-kriterier
30. april 2026
Først opslået (Faktiske)
5. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 82323
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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