<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/NCT03282604</url>
  </required_header>
  <id_info>
    <org_study_id>1-2017-0048</org_study_id>
    <nct_id>NCT03282604</nct_id>
  </id_info>
  <brief_title>The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size</brief_title>
  <official_title>The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size</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>Yes</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 nasotracheal intubation is preferred for oral surgery; it provides an easier view of the&#xD;
      surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are&#xD;
      often not fitted in anatomy of Korean people because of small nostril. When the size of the&#xD;
      tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the&#xD;
      glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to&#xD;
      suggest the ideal length of the nasotracheal tube during the intubation of the selected&#xD;
      tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73&#xD;
      males and 73 females) who are scheduled for nasal intubation for general anesthesia will be&#xD;
      enrolled. The primary outcome is the ideal length of tube that allows the distance from the&#xD;
      vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of&#xD;
      the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril,&#xD;
      length from the nare to the carina and vocal cord are measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">December 6, 2018</completion_date>
  <primary_completion_date type="Actual">December 6, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">146</enrollment>
  <condition>Nasotracheal Intubation for General Anesthesia</condition>
  <arm_group>
    <arm_group_label>male</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>female</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are scheduled for nasotracheal intubation for general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients who are scheduled for nasotracheal intubation for general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age&lt;20 years&#xD;
&#xD;
          2. ASA class III or more&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. emergency surgery&#xD;
&#xD;
          5. nasal airway disease&#xD;
&#xD;
          6. expected difficult intubation (difficult intubation history, Modified Mallampati score&#xD;
             4, mouth opening &lt;2cm, facial anomaly)&#xD;
&#xD;
          7. cervical movement disorder (cervical disease, cervical pain)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Severance</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <removed_countries>
    <country>South Georgia and the South Sandwich Islands</country>
  </removed_countries>
  <reference>
    <citation>Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x.</citation>
    <PMID>8346770</PMID>
  </reference>
  <reference>
    <citation>Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. doi: 10.1111/j.1553-2712.1997.tb03691.x.</citation>
    <PMID>9408424</PMID>
  </reference>
  <reference>
    <citation>Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.</citation>
    <PMID>15845720</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intubation</keyword>
  <keyword>Intratracheal</keyword>
  <keyword>Nasopharynx</keyword>
  <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/NCT03282604
org study id: 1-2017-0048
nct id: NCT03282604
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the
      surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are
      often not fitted in anatomy of Korean people because of small nostril. When the size of the
      tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the
      glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to
      suggest the ideal length of the nasotracheal tube during the intubation of the selected
      tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73
      males and 73 females) who are scheduled for nasal intubation for general anesthesia will be
      enrolled. The primary outcome is the ideal length of tube that allows the distance from the
      vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of
      the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril,
      length from the nare to the carina and vocal cord are measured.
observational model: Cohort
time perspective: Prospective
measure: the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans
time frame: through study completion, an average of 1 year
description: the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina.
arm group label: male
arm group label: female
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
country: South Georgia and the South Sandwich Islands
citation: Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x.
PMID: 8346770
citation: Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. doi: 10.1111/j.1553-2712.1997.tb03691.x.
PMID: 9408424
citation: Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
PMID: 15845720
responsible party type: Sponsor
sharing ipd: No