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Incidence of postoperative shivering and risk factors

Status Approved

  • First Submitted Date

    2018/10/16

  • Registered Date

    2019/02/07

  • Last Updated Date

    2019/01/08

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
    KCT0003472
    Unique Protocol ID CNUHH-2018-121
    Public/Brief Title Incidence of postoperative shivering and risk factors
    Scientific Title Incidence of postoperative shivering and risk factors
    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 CNUHH-2018-121
    Approval Date 2018-08-24
    Institutional Review Board Name Chonnam National University Hwasun Hospital Institutional Review Board/Ethics Committee
    Institutional Review Board Address 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do
    Institutional Review Board Telephone 061-379-7598
    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 Seongheon Lee
    Title Dr.
    Telephone +82-61-379-8546
    Affiliation Chonnam National University Hospital Hwasun Hospital
    Address 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Republic of Korea
    Contact Person for Public Queries
    Name Seongheon Lee
    Title Dr.
    Telephone +82-61-379-8546
    Affiliation Chonnam National University Hospital Hwasun Hospital
    Address 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Republic of Korea
    Contact Person for Updating Information
    Name Taehee Pyeon
    Title Dr.
    Telephone +82-62-220-6895
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of 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 2018-08-24 Actual
    Target Number of Participant 14000
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital Hwasun Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-08-24 ,
  • 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 Chonnam National University Hospital Hwasun Hospital
    Organization Type Medical Institute
    Project ID CNUHH-2018-121
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital Hwasun Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Shivering can cause more severe pain in post-operative patients with tension on the surgical site, interrupting patient monitoring , increasing intraocular pressure and intracranial pressure, and increasing oxygen consumption. There are many reasons for the postoperative shivering, but hypothermia is closely related to shivering in anesthetized patients. Hypothermia is induced by core-to-peripheral redistribution of core-temperature caused by vasodiation with sympathetic block in anesthesia, low operating room temperature, and cold intravenous fluid injection. Also, An afferent temperature signal at the anesthetic site is not transmitted to the body temperature control center in the hypothalamus preoptic region, resulting in a temperature regulation dysfunction.
    But, postoperative shivering can occur in normothremic patients, clear mechanisms are not known. Immediately after anesthesia emergence, the patient hemodynamic status is often unstable and there is high risk of tissue hypoxia due to hypoventilation. At this time, postoperative shivering might be threat of patient’s safety. So, evaluation about incidence and risk factors of postoperative shivering has important role in prevention of postoperative shivering.
  • 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 Retrospective  
    Target Number of Participant 14000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients who underwent surgery under anesthesia and visited the regular recovery room

    Cohort/Group Description

    For patients who underwent surgery under anesthesia and visited the regular recovery room, the occurrence of postoperative shivering and possible risk factors will be investigated.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who underwent surgery under anesthesia and visited the regular recovery room
    Sampling Method
    Non-probability sampling(Purposive sampling): All patients arriving the regular recovery room after anesthesia, who has the complete anesthetic record and postanesthetic recovery record (from 2016 to 2017)
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (T81.1)Shock during or resulting from a procedure, NEC 

    Anesthesia Recovery Period: All patients arriving the regular recovery room after anesthesia, who has the complete anesthetic record and postanesthetic recovery record
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    Adult patients arriving the regular recovery room after general anesthesia
    Exclusion Criteria
    1. Incomplete data
    2. Patients who did not have the abdominal area surgery
    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
    Incidence of postoperative shivering
    Timepoint
    Staying in the regular recovery room after surgery
    Secondary Outcome(s) 1
    Outcome
    Risk factors of postoperative shivering
    Timepoint
    Preoperative and intraoperative period
  • 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 Not provided at time of Registration
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