<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/NCT01719848</url>
  </required_header>
  <id_info>
    <org_study_id>2012-05-079-001</org_study_id>
    <nct_id>NCT01719848</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Airway Assessments With a Gray Zone Approach</brief_title>
  <official_title>Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Failure of advanced airway security has been reported that it could lead lethal complication&#xD;
      such as brain hypoxic damage. There have been controversial reports for the airway assessment&#xD;
      tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity&#xD;
      of pre-existing airway assessment tests and scoring system using a gray zone approach in&#xD;
      patients undergoing general anesthesia required endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV&#xD;
      scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of glottic opening (POGO)</measure>
    <time_frame>During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)</time_frame>
    <description>POGO image will be captured using attachable fiberoptic scope.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Difficult Laryngoscopy</condition>
  <arm_group>
    <arm_group_label>Preoperative airway examination</arm_group_label>
    <description>patients undergoing general anesthesia for any surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurements of parameters related with physical examinations for difficult airway prediction</intervention_name>
    <arm_group_label>Preoperative airway examination</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing general anesthesia for any surgery at Samsung medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 to 80 years old patients undergoing general anesthesia for any operation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous difficult airway history&#xD;
&#xD;
          -  upper airway obstruction disease&#xD;
&#xD;
          -  congenital disorders that are known to relate with difficult airway&#xD;
&#xD;
          -  neurologic symptom associated with neck extension&#xD;
&#xD;
          -  emergent operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung medical center</name>
      <address>
        <city>Seoul</city>
        <zip>715-310</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>April 16, 2014</last_update_submitted>
  <last_update_submitted_qc>April 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Hwan Lee</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Physical examinations, Percentage of glottic opening(POGO)</keyword>
  <!-- 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/NCT01719848
org study id: 2012-05-079-001
nct id: NCT01719848
lead sponsor: 
has dmc: Yes
Failure of advanced airway security has been reported that it could lead lethal complication
      such as brain hypoxic damage. There have been controversial reports for the airway assessment
      tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity
      of pre-existing airway assessment tests and scoring system using a gray zone approach in
      patients undergoing general anesthesia required endotracheal intubation.
POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV
      scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)
observational model: Case-Only
time perspective: Prospective
measure: Percentage of glottic opening (POGO)
time frame: During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered)
description: POGO image will be captured using attachable fiberoptic scope.
arm group label: Preoperative airway examination
description: patients undergoing general anesthesia for any surgery
intervention type: Other
intervention name: Measurements of parameters related with physical examinations for difficult airway prediction
arm group label: Preoperative airway examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jong Hwan Lee
investigator title: assistant professor