<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/NCT01679262</url>
  </required_header>
  <id_info>
    <org_study_id>4-2007-0407</org_study_id>
    <nct_id>NCT01679262</nct_id>
  </id_info>
  <brief_title>Determination of the Optimal Size of Oropharyngeal Airway; Correlation With External Body Measurements</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are several studies that have measured various oropharyngeal airway space distances&#xD;
      using radiological method. However, direct confirmation of optimal size of oropharyneal&#xD;
      airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The&#xD;
      purposes of this study were to directly determinate the proper size of OPA in individual by&#xD;
      FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine&#xD;
      the relationships among the size of OPA, straight length from the incisors to the tip of the&#xD;
      epiglottis by laryngoscopy, patient height, and external facial measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal size of OPA</measure>
    <time_frame>1 min after each FOB measurement</time_frame>
    <description>Primary Outcome - 기술(Description) The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. The optimal size of OPAs in individuals was defined that the distal end of OPA is placed the tip of epiglottis as close as possible without impingement on the epiglottis when the flange of OPA contact with the four central incisors.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Ear,Nose and Throat Surgery</condition>
  <arm_group>
    <arm_group_label>Optimal size of OPAs</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Guedel type color-coded OPAs</intervention_name>
    <description>The OPAs was used four different sizes as No. 8 (80 mm, green), 9 (90 mm, yellow), 10 (100 mm, red), and 11 (110 mm, orange) in regular sequence. The curvilinear distance from the incisors to the tip of the epiglottis was measured by FOB (Olympus LF-GP; Olympus Optical Co., Tokyo, Japan) with tape marking via each size of OPAs. The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. .</description>
    <arm_group_label>Optimal size of OPAs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class I-II 2. 20-70 years adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. an abnormal airway anatomy in preoperative radiologic study.&#xD;
&#xD;
          -  2. cervical spine pathology,&#xD;
&#xD;
          -  3. a history of difficult intubation,&#xD;
&#xD;
          -  4. neurologic disease or cardiovascular disease,&#xD;
&#xD;
          -  5. obesity (body mass index ≥ 30 kg m-1),&#xD;
&#xD;
          -  6. dental problem&#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>Wyun Kon Park, Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01679262
org study id: 4-2007-0407
nct id: NCT01679262
lead sponsor: 
has dmc: No
There are several studies that have measured various oropharyngeal airway space distances
      using radiological method. However, direct confirmation of optimal size of oropharyneal
      airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The
      purposes of this study were to directly determinate the proper size of OPA in individual by
      FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine
      the relationships among the size of OPA, straight length from the incisors to the tip of the
      epiglottis by laryngoscopy, patient height, and external facial measurements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Optimal size of OPA
time frame: 1 min after each FOB measurement
description: Primary Outcome - 기술(Description) The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. The optimal size of OPAs in individuals was defined that the distal end of OPA is placed the tip of epiglottis as close as possible without impingement on the epiglottis when the flange of OPA contact with the four central incisors.
arm group label: Optimal size of OPAs
arm group type: Other
intervention type: Device
intervention name: Guedel type color-coded OPAs
description: The OPAs was used four different sizes as No. 8 (80 mm, green), 9 (90 mm, yellow), 10 (100 mm, red), and 11 (110 mm, orange) in regular sequence. The curvilinear distance from the incisors to the tip of the epiglottis was measured by FOB (Olympus LF-GP; Olympus Optical Co., Tokyo, Japan) with tape marking via each size of OPAs. The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. .
arm group label: Optimal size of OPAs
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor