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Selection a suitable nostril for nasotracheal intubation

Status Approved

  • First Submitted Date

    2020/05/20

  • Registered Date

    2020/05/28

  • Last Updated Date

    2020/05/19

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
    KCT0005067
    Unique Protocol ID HYUH 2020-03-028-002
    Public/Brief Title Selection a suitable nostril for nasotracheal intubation
    Scientific Title Selection a suitable nostril for nasotracheal 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 HYUH 2020-03-028-002
    Approval Date 2020-05-21
    Institutional Review Board Name Institutional Review Board of Hanyang University Seoul Hospital
    Institutional Review Board Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul
    Institutional Review Board Telephone 02-2220-0673
    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 Hyunyoung Lim
    Title Assistant professor
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro. Seongdong-cu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Hyunyoung Lim
    Title Assistant professor
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro. Seongdong-cu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Hyunyoung Lim
    Title Assistant professor
    Telephone +82-2-2290-8680
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro. Seongdong-cu, 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 2020-06-01 Anticipated
    Target Number of Participant 138
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-01 ,
  • 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
  • 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
    In head and neck surgery or dental surgery, the insertion of naso-tracheal tube may be necessary to clearify the operational view. At this time, the naso-tracheal tube is inserted into one nostril, and side effects such as nasal bleeding or septal damage may occur in this process. 
      The nasal septal deviation has a various incidence even in asymptomatic people. The naso-tracheal intubation in the usual method for patients with asymptomatic nasal septal deviation may be performed at a narrower nostril, increasing the incidence of side effects or failing to intubating.
      This study is aimed to investigate wheather side effects and failure rates are related to nasal septal deviation and the occurrence of nasal septal deviation after extubation when a nostril is selected in usual method to perform intubation of naso-tracheal tube.
  • 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 Prospective  
    Target Number of Participant 138
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    The group of patients undergoing naso-tracheal intubation with a more breathable nostril.

    Cohort/Group Description

    When a nostril is selected for naso-tracheal intubation, the intubation is performed on a better breathable nostril according to the subjective judgment of the patient by blocking one nostril and inducing nasal breathing. We observe nasal bleeding during naso-tracheal intubation and failure rate of tracheal intubation.
    Cohort/
    Group 2

    Cohort/Group Label

    The group of patients undergoing naso-tracheal intubation with a less breathable nostril.

    Cohort/Group Description

    When a nostril is selected for naso-tracheal intubation, the intubation is performed on the opposite side of the better breathable nostril according to the subjective judgment of the patient by blocking one nostril and inducing nasal breathing. We observe nasal bleeding during naso-tracheal intubation and failure rate of tracheal intubation.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients aged 19 to under 75 who undergo head and neck surgery at Hanyang University Seoul Hostpital
    Sampling Method
    The two groups are assigned randomly.
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C76.0)Malignant neoplasm of head, face and neck 

    Neoplasms [C04] Wounds and Injuries [C26]
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~74Year

    Description

    -Patients who require intubation of a naso-tracheal tube during general anesthesia for head and neck surgery
    -Adult patients aged 19 to under 75
    -I, II and III of American Society of Anesthesiologist(ASA) physical status classification 
    -Patients who have previously agreed to the study
    Exclusion Criteria
    -Patients with a history of difficult tracheal intubation
    -Patients who are expected to have difficulty in tracheal intubation or mannual mask ventilation
    -Patients who are pregnant
    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 Safety
    Primary Outcome(s) 1
    Outcome
    Nasal bleeding
    Timepoint
    After induction of anesthesia
    Primary Outcome(s) 2
    Outcome
    Failure rate of naso-tracheal intubation
    Timepoint
    After induction of anesthesia
    Secondary Outcome(s) 1
    Outcome
    The level of resistance when the naso-tracheal tube passes through the nasal cavity.
    Timepoint
    After induction of anesthesia
    Secondary Outcome(s) 2
    Outcome
    Number of attempts at naso-tracheal intubation
    Timepoint
    After induction of anesthesia
    Secondary Outcome(s) 3
    Outcome
    Degree of nasal septal curvature in radiology of the head and neck.
    Timepoint
    Before and after 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 No
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