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Predictive power of EEG connectivity change for the postoperative delirium in elderly patients undergoing non-cardiac surgery

Status Approved

  • First Submitted Date

    2020/08/01

  • Registered Date

    2020/08/11

  • Last Updated Date

    2022/04/18

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005310
    Unique Protocol ID 3-2020-0223
    Public/Brief Title Predictive power of EEG connectivity change for the postoperative delirium in elderly patients undergoing non-cardiac surgery
    Scientific Title Predictive power of EEG connectivity change for the postoperative delirium in elderly patients undergoing non-cardiac surgery
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 3-2020-0223
    Approval Date 2020-07-24
    Institutional Review Board Name Institutional Review Board of Gangnam Sevrance hostpital
    Institutional Review Board Address 211, Eonju-ro, Gangnam-gu, Seoul
    Institutional Review Board Telephone 02-2019-4624
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Dong Woo Han
    Title Professor
    Telephone +82-2-2019-6891
    Affiliation Yonsei University Health System, Gangnam Severance Hospital
    Address 211, Eonju-ro, Gangnam-gu, Seoul 06273, Korea
    Contact Person for Public Queries
    Name Jayyoung Bae
    Title Assistant Professor
    Telephone +82-2-2019-6610
    Affiliation Yonsei University Health System, Gangnam Severance Hospital
    Address 211, Eonju-ro, Gangnam-gu, Seoul 06273, Korea
    Contact Person for Updating Information
    Name Jayyoung Bae
    Title Assistant Professor
    Telephone +82-2-2019-6610
    Affiliation Yonsei University Health System, Gangnam Severance Hospital
    Address 211, Eonju-ro, Gangnam-gu, Seoul 06273, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-08-12 Actual
    Target Number of Participant 172
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-08-12 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University Health System, Gangnam Severance Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Health System, Gangnam Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The occurrence of delirium in elderly patients decreases the patient's quality of life, increases medical costs, increases long-term cognitive decline, and increases complications and mortality. Prediction and early diagnosis are important for the prevention and proper treatment of delirium after surgery, however, accurate and efficient clinical examination methods have not been developed.
    
    Recently, a study has been published that the occurrence of delirium after surgery is related to the depth of anesthesia during general anesthesia, the burst-suppression ratio, and the symmetry of bilateral EEG. In this regard, we decided to investigate whether the perioperative change of EEG connectivity in elderly patients can predict the occurrence of delirium after the non-cardiac surgery.
    
    In this study, the EEG signals during the perioperative period are processed with various mathematical algorithms to calculate EEG connectivity. Then, the EEG connectivity changes are compared with the results of the postoperative confusion assessment method(CAM) to validate its relation with the occurrence of the delirium. Additional EEG parameters such as the change of power spectral density and the burst-suppression ratio will also be investigated to find out the relationship with the postoperative delirium. By integrating the abovementioned EEG parameters and the known risk factors of delirium, we wish to develop a more accurate and efficient clinical diagnostic method.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 172
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    The elderly patients age over 65, undergoing conc-cardiac surgery with the general anesthesia.

    Cohort/Group Description

    First, the day before the surgery, the K-MOCA test, and the Hospital Anxiety and Depression Scale test are performed on the participant to evaluate the preoperative cognitive function. On the day of the surgery, after re-confirm the consent of the participant, the investigator collects the 15 mins of the preoperative EEG data at the pre-treatment room. After entering the operating room, ordinary anesthetic care is provided to the participant, and EEG data is collected during the surgery. During the surgery, demographic data of the participant, ASA classification, medical history, type and use of an anesthetic agent, amount of transfusion, narcotic analgesic use, antiemetic use, and total anesthesia time are recorded. After the surgery has done, the investigator collects the postoperative EEG data at the post-anesthesia care unit for 30 minutes at the PACU. At the PACU, the pain scale evaluation, narcotic analgesic use, antiemetic use, and confusion assessment method(CAM) results(15 and 60 minutes after entering the PACU) are recorded. To evaluate postoperative cognitive function, the CAM is conducted to the participant on the postoperative day of 1, 2, 3, and the day before the discharge day. On the day before discharge, K-MOCA and hospital anxiety and depression scale tests are performed once more.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    The elderly patients age over 65, undergoing non-cardiac surgery with the general anesthesia.
    Sampling Method
    simple random sampling
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F05.8)Other delirium 

    Delirium
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    The elderly patients age over 65, undergoing non-cardiac surgery with the general anesthesia.
    Exclusion Criteria
    ① In case of emergency surgery
    ② Underlying severe systemic infection or hemodynamic instability.
    ③ Difficulty in communication due to the neurologic diseases such as dementia, stroke, seizure, etc.
    ④ Difficulty in communication due to the visual/hearing impairment, illiteracy, or foreigner.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Change of the perioperative EEG connectivity.
    Timepoint
    The EEG connectivity will be calculated after the surgery, using perioperative (before/during/after the surgery) EEG signals.
    Primary Outcome(s) 2
    Outcome
    Confusion assessment method (Postoperative cognitive evaluation)
    Timepoint
    Right after the surgery, postoperative day1,2,3 and the day before the discharge of the patient.
    Secondary Outcome(s) 1
    Outcome
    Changes of the perioperative power spectral density of EEG
    Timepoint
    The power spectral density of EEG will be calculated after the surgery, using perioperative (before/during/after the surgery) EEG signals.
    Secondary Outcome(s) 2
    Outcome
    Perioperative burst-suppression ratio
    Timepoint
    The burst-suppression ratio will be calculated after the surgery, using perioperative (before/during/after the surgery) EEG signals.
    Secondary Outcome(s) 3
    Outcome
    Hospital Anxiety and Depression Scale (Pre-operative congnitive evaluation)
    Timepoint
    After the admission of the patient, before the surgery. The day before the discharge of the patient.
    Secondary Outcome(s) 4
    Outcome
    Korean-Montreal Cognitive Assessment (Pre-operative congnitive evaluation)
    Timepoint
    After the admission of the patient, before the surgery. The day before the discharge of the patient.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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