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The use of the "no zone" approach for assessment of traumatic neck injury

Status Approved

  • First Submitted Date

    2020/01/03

  • Registered Date

    2020/01/29

  • Last Updated Date

    2020/01/13

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
    KCT0004662
    Unique Protocol ID CR319118
    Public/Brief Title The use of the "no zone" approach for assessment of traumatic neck injury
    Scientific Title The use of the "no zone" approach for assessment of traumatic neck injury
    Acronym UNATNI
    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 CR319118
    Approval Date 2019-10-22
    Institutional Review Board Name Yonsei University Wonju Severance Christian Hospital Institutional Review Board
    Institutional Review Board Address 20, Ilsan-ro, Wonju-si, Gangwon-do
    Institutional Review Board Telephone 033-741-1703
    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 Pil Young Jung
    Title M.D., Ph.D.
    Telephone +82-33-741-0114
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea
    Contact Person for Public Queries
    Name Ji Wool Ko
    Title M.D.
    Telephone +82-33-741-0114
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do, Republic of Korea
    Contact Person for Updating Information
    Name Ji Wool Ko
    Title M.D.
    Telephone +82-33-741-0114
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20, Ilsan-ro, Wonju-si, Gangwon-do, 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 2019-10-31 Actual
    Target Number of Participant 168
    Primary Completion Date 2020-01-10 , Anticipated
    Study Completion Date 2020-01-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-10-31 ,
  • 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, Wonju Severance Christian Hospital
    Organization Type Medical Institute
    Project ID CR319118
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Traumatic neck injury comprises approximately 5-10% of all traumatic injuries. Despite its low incidence, the number of mortalities due to neck injury is still high. Anatomical features such as the trachea, esophagus, great vessels, and nerves are crowded in small spaces and are relatively unprotected. Therefore, mandatory surgery is generally performed in cases of zone II injury, according to the classification of the anatomical zones of the neck; zone I spans from the clavicles to the cricoid, zone II spans from cricoid to the angle of the mandible, and zone III ranges from the angle of the mandible to the base of the skull. This approach is referred to as the zone-based algorithm and is a traditional assessment for  traumatic neck injury. Routine neck exploration in hemodynamically stable patients leads to a high rate of negative exploration, longer hospital stay, and an increased rate of complications, such as surgical site infection and sepsis. Therefore the management of neck injuries has changed from mandatory exploration of all wounds that penetrate the platysma to an increasingly selective approach, based on patient symptoms. The selective surgery is based on a “no zone” approach, which is to determine the direction of treatment by classifying the symptoms that can be caused by damage to the major vascular, digestive, and respiratory systems. If the patients are hemodynamically unstable or the hard signs are confirmed, surgery is performed without examination. Otherwise, the procedures are performed. 
    The purpose of this study was to confirm the usefulness of the “no zone” approach in traumatic neck injuries. We hypothesized that hard signs in symptomatic approaches may be useful for predicting internal organ injuries in the neck.
  • 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 Case-control
    Time Perspective Retrospective  
    Target Number of Participant 168
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    traumatic neck injury patients

    Cohort/Group Description

    Identify predictors of internal organ injury of neck by comparing groups with and without internal organ injury
    Cohort/
    Group 2

    Cohort/Group Label

    traumatic neck injury patients who underwent surgery

    Cohort/Group Description

    Identify predictors of internal organ injury of neck by comparing groups with and without internal organ injury in patients who underwent surgery
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description
    hemoglobin, lactate, prothrombin time international normal ratio(PT-INR)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Between January 2014 and December 2018, we prospectively enrolled patients with neck injuries who were treated at the Level I Trauma Center of Wonju Severance Christian Hospital and whose data were part of the Korea Trauma Data Bank (KTDB).
    Sampling Method
    Extraction of patients with diagnosis of traumatic neck injury in KTDB(Korean trauma data base)
    The purposive sampling was used as the non-probability extraction (non-probability extraction).
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (S19.9)Unspecified injury of neck 

    neck injuries
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    Between January 2014 and December 2018, we prospectively enrolled patients with neck injuries who were treated at the Level I Trauma Center of Wonju Severance Christian Hospital and whose data were part of the Korea Trauma Data Bank (KTDB).
    Exclusion Criteria
    patients with only contusion of neck or whiplash syndrome were excluded
    Healthy Volunteers Yes
  • 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
    internal organs injuries (airway, vessels, nerve, digestive, thyroid and hyoid bone) of neck according to clinical signs (hard signs, soft signs, asymptomatic)
    Timepoint
    Confirmation of clinical features(hard signs, soft signs, asymptomatic) upon arrival at the emergency room, and injuries to major organs in the neck (airway, vessels, nerve, digestive, thyroid and hyoid bone) after CT or surgery
    Secondary Outcome(s) 1
    Outcome
    Internal organs injuries (airway, vessels, nerve, digestive, thyroid and hyoid bone) of neck according to anatomical neck zone (zone I, II, III)
    Timepoint
    Confirmation of anatomical zone (zone I, II, III) upon arrival at the emergency room, and injuries to major organs in the neck (airway, vessels, nerve, digestive, thyroid and hyoid bone) after CT or surgery
  • 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 Yes
    Time of Sharing 2020. 2
    Way of Sharing Available on Request
    (jiulko@yonsei.ac.kr)
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