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Accuracy of surface landmark palpation for identification of the cricothyroid membrane in female patients who preoperatively predicted difficult airway intubation

Status Approved

  • First Submitted Date

    2021/02/02

  • Registered Date

    2021/02/17

  • Last Updated Date

    2021/02/02

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
    KCT0005902
    Unique Protocol ID PC21OISI0014
    Public/Brief Title A study on the diffference of the cricothyroid membrane identification between difficult airway and normal airway
    Scientific Title Accuracy of surface landmark palpation for identification of the cricothyroid membrane in female patients who preoperatively predicted difficult airway intubation
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    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 PC21OISI0014
    Approval Date 2021-01-28
    Institutional Review Board Name Institutional Review Board of Eunpyeong St. Mary's Hospital, The Catholic University of Korea
    Institutional Review Board Address 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
    Institutional Review Board Telephone 02-2030-3715
    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 Soyeon Lee
    Title Fellow
    Telephone +82-2-2030-3862
    Affiliation The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Address 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Soyeon Lee
    Title Fellow
    Telephone +82-2-2030-3862
    Affiliation The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Address 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Soyeon Lee
    Title Fellow
    Telephone +82-2-2030-3862
    Affiliation The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Address 1021, Tongil-ro, Eunpyeong-gu, Seoul, 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 Not yet recruiting
    Date of First Enrollment 2021-02-15 Anticipated
    Target Number of Participant 60
    Primary Completion Date 2022-01-26 , Anticipated
    Study Completion Date 2022-01-26 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-02-15 ,
  • 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 The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Hypothesis: Palpation of the cricothyroid membrane in female patients who are preoperatively expected to have difficult airway would be less accurate than in female patients with normal airway.
    The first endpoint of the study is to compare the accuracy of surface landmark palpation for cricothyroid membrane identification in female patients who are preoperatively predicted to have difficult airway and normal airway.
    
    Cricothyroidotomy is a way of emergent airway puncture to establish a patent airway during life-threatening situations such as "Can't intubate, can't ventilate (CICV)" or "Can't intubate, can't oxygenate (CICO)". Clinicians need to get familiar with relevant anatomy and develop the ability to identify the cricothyroid membrane (CTM). One way to improve familiarity with the anatomy is to palpate the structures of the anterior neck regularly when examining patients. The boundaries of the CTM are the thyroid cartilage superiorly, the cricoid cartilage inferiorly, and the cricothyroideus muscles laterally on both sides. Identifying the CTM is more confusing in women than in men because laryngeal prominence is less prominent. To get over this hardship, bedside ultrasound has been proposed as a method for identifying the cricothyroid membrane (CTM). In this study, we will examine the patients' airway before the induction of anesthesia and analyze the diffference of the CTM identification accuracy between difficult airway and normal airway,
  • 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 60
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    difficult airway group

    Cohort/Group Description

    Based on a physical examination(Palpation) : If any of "3-3-2 rules" are applicable
    ** 3-3-2 rules : 
    (a) Inter-incisor distance <3 finger breadths
    (b) Hyoid-to-mental distance < 3 finger breadths
    (c) Thyroid-to-hyoid distance <2 finger breadths
    Cohort/
    Group 2

    Cohort/Group Label

    normal airway group

    Cohort/Group Description

    Based on a physical examination(Palpation) : If none of "3-3-2 rules" are applicable
    ** 3-3-2 rules : 
    (a) Inter-incisor distance <3 finger breadths
    (b) Hyoid-to-mental distance < 3 finger breadths
    (c) Thyroid-to-hyoid distance <2 finger breadths
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Female patients who undergo surgery under general anesthesia or regional anesthesia in the Eunpyeong St. Mary's Hospital.
    Sampling Method
    Among female patients who undergo surgery under general anesthesia or regional anesthesia in the Eunpyeong St. Mary's Hospital during the study period, 30 patients who are preoperatively predicted to have difficult airway and 30 patients with normal airway will be enrolled prospectively.
    Condition(s)/Problem(s)    Not Applicable-Etc 

    airway management
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~74Year

    Description

    1) Sex: Female
    2) Adults: over 19 and under 75 years old
    3) ASA(American Society of Anesthesiologists) physical status 1 or 2
    Exclusion Criteria
    1) Patients who disagree with the participation in this study
    2) Patients with cognitive impairments, who can not understand this study
    3) Pregnant women
    4) Sex: Male
    3) Age under 19 or over 75 
    4) ASA(American Society of Anesthesiologists) physical status ≥3
    5) Patients with pathologic lesion in the neck
    6) Patients who undergo neck surgeries
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Diffference of the cricothyroid membrane identification between difficult airway and normal airway
    Timepoint
    Before induction of an anesthesia
    Secondary Outcome(s) 1
    Outcome
    Ultrasonographic identification of the cricothyroid membrane
    Timepoint
    Before induction of an anesthesia
  • 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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