<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04499222</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0654</org_study_id>
    <nct_id>NCT04499222</nct_id>
  </id_info>
  <brief_title>Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes</brief_title>
  <official_title>Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal&#xD;
      tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt&#xD;
      TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the&#xD;
      upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral&#xD;
      neck position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position</measure>
    <time_frame>1 minute after nasotracheal intubation</time_frame>
    <description>whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).&#xD;
the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The adequacy of nasotracheal tube cuff location in extended and flexed neck position</measure>
    <time_frame>1 minute after nasotracheal intubation</time_frame>
    <description>whether the tube cuff is located below the vocal cords in extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords in neutral neck position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adequacy of nasotracheal tube length</measure>
    <time_frame>1 minute after nasotracheal intubation</time_frame>
    <description>whether the tube cuff cannot be located 3cm below the vocal cords owing to short length of nasotracheal tube.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Nasotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Portex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>usage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mallinckrodt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portex</intervention_name>
    <description>nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.</description>
    <arm_group_label>Portex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mallinckrodt</intervention_name>
    <description>nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.</description>
    <arm_group_label>Mallinckrodt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal&#xD;
        intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under 20 years old&#xD;
&#xD;
          2. Patients with ASA class IV or higher&#xD;
&#xD;
          3. Pregnant women&#xD;
&#xD;
          4. Patients receiving emergency surgery&#xD;
&#xD;
          5. Patients who have nasal disease or who undergo nose surgery because of nasal disease&#xD;
&#xD;
          6. Patient with craniofacial anomaly&#xD;
&#xD;
          7. Patients with impaired cervical motion&#xD;
&#xD;
          8. Patients who can not read the consent form or are not fluent in Korean (illiterate,&#xD;
             foreigner)&#xD;
&#xD;
          9. Patients who refused the clinical trial Patients with dementia or cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyun Joo Kim, MD</last_name>
    <phone>82-2-2224-1389</phone>
    <email>JJOLLONG@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Hyun Joo Kim, MD</last_name>
      <phone>82-2-2224-1389</phone>
      <email>JJOLLONG@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04499222
org study id: 4-2020-0654
nct id: NCT04499222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal
      tube (PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom], Mallinckrodt
      TaperGuard [Covidien, Ireland]) depth in neutral, extended and flexed neck position when the
      upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral
      neck position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position
time frame: 1 minute after nasotracheal intubation
description: whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).
the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).
measure: The adequacy of nasotracheal tube cuff location in extended and flexed neck position
time frame: 1 minute after nasotracheal intubation
description: whether the tube cuff is located below the vocal cords in extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords in neutral neck position.
measure: The adequacy of nasotracheal tube length
time frame: 1 minute after nasotracheal intubation
description: whether the tube cuff cannot be located 3cm below the vocal cords owing to short length of nasotracheal tube.
arm group label: Portex
arm group type: Experimental
description: usage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube
arm group label: Mallinckrodt
arm group type: Active Comparator
description: usage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube
intervention type: Device
intervention name: Portex
description: nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.
arm group label: Portex
intervention type: Device
intervention name: Mallinckrodt
description: nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.
arm group label: Mallinckrodt
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hyun Joo Kim, MD
phone: 82-2-2224-1389
email: JJOLLONG@yuhs.ac
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No