xml: <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/NCT05967338</url>
    </required_header>
    <id_info>
      <org_study_id>2022/12-10</org_study_id>
      <nct_id>NCT05967338</nct_id>
    </id_info>
    <brief_title>Glottis Visualization in Different Lifting Methods</brief_title>
    <official_title>Comparison of Epiglottis Lifting Methods Using a McGrath Video Laryngoscope: Direct vs. Indirect</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zonguldak Bulent Ecevit University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zonguldak Bulent Ecevit 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>
        Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has&#xD;
        become popular because it is lightweight and can be quickly and hygienically prepared by&#xD;
        changing the blade. The aim of this study was to compare the efficacy of two different&#xD;
        methods (direct and indirect) for epiglottis removal during visualization of the glottis&#xD;
        using the McGrath MAC VL.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 30, 2023</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>POGO scores</measure>
      <time_frame>1 day (through intubation )</time_frame>
      <description>percentage of glottic opening</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cormack-Lehane classification</measure>
      <time_frame>1 day (through intubation )</time_frame>
      <description>assessment of laryngeal view during laryngoscopy</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">1</enrollment>
    <condition>Intubation</condition>
    <condition>Glottis Visualization</condition>
    <arm_group>
      <arm_group_label>Group Direct</arm_group_label>
      <description>glottis visualization in direct lifting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group Indirect</arm_group_label>
      <description>glottis visualization in indirect lifting</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>using McGrath Video Laryngoscope</intervention_name>
      <description>glottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope</description>
      <arm_group_label>Group Direct</arm_group_label>
      <arm_group_label>Group Indirect</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ASA I-II, 18-65 years old patients undergoing elective surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA I-II&#xD;
  &#xD;
            -  general anesthesia in elective surgeries&#xD;
  &#xD;
            -  18-65 years old&#xD;
  &#xD;
            -  body mass index (25-30)&#xD;
  &#xD;
            -  no risk of difficult intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergic to study drugs&#xD;
  &#xD;
            -  pregnant women&#xD;
  &#xD;
            -  emergency cases&#xD;
  &#xD;
            -  those with a history of difficult intubation&#xD;
  &#xD;
            -  those without consent&#xD;
  &#xD;
            -  those at risk of aspiration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Zonguldak Bülent Ecevit University</name>
        <address>
          <city>Zonguldak</city>
          <state>Kozlu</state>
          <zip>67600</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zonguldak Bulent Ecevit University</investigator_affiliation>
      <investigator_full_name>Keziban Bollucuoglu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Endotrakeal intubation</keyword>
    <keyword>Epiglottis</keyword>
    <keyword>Glottis</keyword>
    <keyword>McGrath MAC video laryngoscope</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967338
  org study id: 2022/12-10
  nct id: NCT05967338
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has
        become popular because it is lightweight and can be quickly and hygienically prepared by
        changing the blade. The aim of this study was to compare the efficacy of two different
        methods (direct and indirect) for epiglottis removal during visualization of the glottis
        using the McGrath MAC VL.
  observational model: Cohort
  time perspective: Prospective
  measure: POGO scores
  time frame: 1 day (through intubation )
  description: percentage of glottic opening
  measure: Cormack-Lehane classification
  time frame: 1 day (through intubation )
  description: assessment of laryngeal view during laryngoscopy
  arm group label: Group Direct
  description: glottis visualization in direct lifting
  arm group label: Group Indirect
  description: glottis visualization in indirect lifting
  intervention type: Device
  intervention name: using McGrath Video Laryngoscope
  description: glottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope
  arm group label: Group Direct
  arm group label: Group Indirect
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Zonguldak Bulent Ecevit University
  investigator full name: Keziban Bollucuoglu
  investigator title: Principal Investigator
  sharing ipd: No