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Efficacy of pupillary light reflex (PLR) to detect postoperative delirium in elderly patients

Status Approved

  • First Submitted Date

    2019/11/20

  • Registered Date

    2019/12/09

  • Last Updated Date

    2019/11/29

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
    KCT0004514
    Unique Protocol ID 2019-10-057-001
    Public/Brief Title Pupillary light reflex and postoperative delirium
    Scientific Title Efficacy of pupillary light reflex (PLR) to detect postoperative delirium in elderly patients
    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 2019-10-057-001
    Approval Date 2019-11-19
    Institutional Review Board Name Hanyang University Hospital Institutional Review Board
    Institutional Review Board Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul
    Institutional Review Board Telephone 02-2290-9653
    Data Monitoring Committee No
  • 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 Eugene Kim
    Title Professor
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul
    Contact Person for Public Queries
    Name Soo Yeon Kim
    Title Fellow
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul
    Contact Person for Updating Information
    Name Soo Yeon Kim
    Title Fellow
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul
  • 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 Not yet recruiting
    Date of First Enrollment 2019-12-04 Anticipated
    Target Number of Participant 67
    Primary Completion Date 2020-11-30 , Anticipated
    Study Completion Date 2020-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-12-04 ,
  • 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 Hanyang University Seoul Hospital
    Organization Type Medical Institute
    Project ID 2019-10-057-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hanyang University Seoul Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Delirium is acute cognitive dysfunction accompanied by sudden changes in consciousness level and unstructured thinking, as well as attention deficit. Patients who develop delirium during hospitalization have increased morbidity and overall medical cost also increases. It has been reported that the incidence of delirium after surgery is higher in elderly patients, and it increases the risk of postoperative complications, prolongs the hospitalization period, intensive care unit hospitalization period, and increases the mortality rate in the long term. 
    The evaluation of mental status and diagnosis of delirium in recovery state is somewhat difficult because of acute postoperative pain, use of analgesics and poor coordination of the patient. Confusion assessment method for intensive care unit (CAM-ICU) is widely used as a standard for the diagnosis of delirium, even for intubated or sedated patients, with high sensitivity and specificity. Although it is relatively simple and does not need much time for evaluation, the reliability is highly dependent on the assessor’s skill. Therefore, the need for an objective assessment method for diagnosing delirium in the recovery state is increasing.
    Recently, the use of pupillary light reflex has been discussed for assessing mental status in recovery room or transient delirium after general anesthesia. This study was planned to determine the usefulness of the pupillary light reflex for the diagnosis of delirium in the recovery room in elderly patients after general anesthesia.
  • 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 67
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Elderly patients undergoing general anesthesia

    Cohort/Group Description

    Patients aged 65 years or older who are planned hip, knee or spine surgery under general anesthesia will be included. Pupillary light reflex will be measured by a portable infrared pupillometry (PLR-3000, Neuropticsinc., CA, USA) and whether delirium occurs after surgery will be determined using the CAM-ICU (Confusion Assessment Method for the ICU).
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients aged 65 years or older who are planned hip, knee or spine surgery under general anesthesia
    Sampling Method
    Non-probablity sampling
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F05.8)Other delirium 

    Anesthesia, General
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    - Patients undergoing general anesthesia for hip, knee or spine surgery 
    - Age 65 years old or older 
    - Patients who are above the standard level for each age group on the Mini-Mental State Examination (MMSE)
    Exclusion Criteria
    - American Society of Anesthesiologist(ASA) physical status classification IV, V 
    - If normal assessment is difficult because of language barrier, speech disorder, sleep disturbance, mental retardation and dementia 
    - If communication is difficult because of visual or hearing impairment 
    - History of anesthesia and surgery within a month
    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
    Average dilation velocity (ADV) of pupillary light reflex after 30 and 60 minutes of admisson to post-anesthesia care unit (PACU)
    Timepoint
    30 and 60 minutes after PACU admission
    Primary Outcome(s) 2
    Outcome
    Development of delirum in PACU based on CAM-ICU
    Timepoint
    30 and 60 minutes after PACU admission
    Secondary Outcome(s) 1
    Outcome
    Other measurements of pupillary light reflex before and after of general anesthesia
    Timepoint
    before general anesthesia, right after the admissino to post-anesthesia care unit (PACU), 30 minutes and 1 hour after PACU admission
    Secondary Outcome(s) 2
    Outcome
    Richmond Agitation-Sedation Scale (RASS) and numeric rating scale (NRS) in PACU
    Timepoint
    immediately after PACU admission, 10, 20, 30 and 60 minutes after PACU admission
    Secondary Outcome(s) 3
    Outcome
    Development of postoperative delirium and severity of delirium after PACU discharge
    Timepoint
    At postoperative day 1, 2 and 3
  • 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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