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- Essai clinique NCT07567729
Effectiveness of Electroencephalography Guided Anesthesia (EEG Anesthesia)
30 avril 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
225
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ariel Clinical Research Coordinator Associate
- Numéro de téléphone: 650-724-3021
- E-mail: arielkay@stanford.edu
Sauvegarde des contacts de l'étude
- Nom: Maya Clinical Research Coordinator Associate
- Numéro de téléphone: 650-724-2620
- E-mail: mcaple@stanford.edu
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Aucune intervention: 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.
|
|
|
Autre: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Minimum Alveolar Concentration (MAC)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 janvier 2031
Dates d'inscription aux études
Première soumission
24 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
5 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 82323
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .