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/NCT05968781</url>
    </required_header>
    <id_info>
      <org_study_id>2307-023-1443</org_study_id>
      <nct_id>NCT05968781</nct_id>
    </id_info>
    <brief_title>Predictive Factors for Successful Videolaryngoscopic Intubation Without Stylet</brief_title>
    <official_title>A Prospective Observational Study of Predictive Factors for Successful Videolaryngoscopic Intubation Without Stylet</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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 investigators aimed to evaluate the predictive factors for successful videolaryngoscopic&#xD;
        intubation without stylet.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>First-pass success rate of videolaryngoscopic intubation without stylet</measure>
      <time_frame>From the start of endotracheal intubation to 120 seconds</time_frame>
      <description>An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Success rate of videolaryngoscopic intubation without stylet using BURP maneuver after failure of the first attempt</measure>
      <time_frame>From the start of endotracheal intubation to 120 seconds</time_frame>
      <description>An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of using a stylet for the success of videolaryngoscopic intubation after the failure of the second attempt using the BURP maneuver</measure>
      <time_frame>From the start of endotracheal intubation to 120 seconds</time_frame>
      <description>An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of successful endotracheal intubation after the failure of the third attempt using stylet</measure>
      <time_frame>From the start of endotracheal intubation to 120 seconds</time_frame>
      <description>An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to completion of endotracheal intubation</measure>
      <time_frame>From the start of endotracheal intubation to 120 seconds</time_frame>
      <description>An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords</description>
    </secondary_outcome>
    <enrollment type="Anticipated">226</enrollment>
    <condition>Intubation; Difficult or Failed</condition>
    <condition>Videolaryngoscopy</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients undergoing general anesthesia and endotracheal intubation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 19 years and older&#xD;
  &#xD;
            -  Patients undergoing general anesthesia for elective surgery and requiring endotracheal&#xD;
               intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with suspected cervical spine injury&#xD;
  &#xD;
            -  Patients requiring rapid sequence induction and intubation.&#xD;
  &#xD;
            -  Patients with airway disorders&#xD;
  &#xD;
            -  Body Mass Index &gt; 35 kg/m2&#xD;
  &#xD;
            -  Patients with a history of difficult intubation or, based on clinical judgment,&#xD;
               anticipated difficult intubation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 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>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Hyun-Kyu Yoon</investigator_full_name>
      <investigator_title>Clinical assistant professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05968781
  org study id: 2307-023-1443
  nct id: NCT05968781
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aimed to evaluate the predictive factors for successful videolaryngoscopic
        intubation without stylet.
  observational model: Cohort
  time perspective: Prospective
  measure: First-pass success rate of videolaryngoscopic intubation without stylet
  time frame: From the start of endotracheal intubation to 120 seconds
  description: An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords
  measure: Success rate of videolaryngoscopic intubation without stylet using BURP maneuver after failure of the first attempt
  time frame: From the start of endotracheal intubation to 120 seconds
  description: An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords
  measure: Incidence of using a stylet for the success of videolaryngoscopic intubation after the failure of the second attempt using the BURP maneuver
  time frame: From the start of endotracheal intubation to 120 seconds
  description: An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords
  measure: Incidence of successful endotracheal intubation after the failure of the third attempt using stylet
  time frame: From the start of endotracheal intubation to 120 seconds
  description: An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords
  measure: Time to completion of endotracheal intubation
  time frame: From the start of endotracheal intubation to 120 seconds
  description: An intubation attempt is defined as passing the laryngoscope blade between the patient's teeth. Duration of endotracheal intubation is defined from the moment the operator grasps the tube until the black line on the tube passes through the vocal cords
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Hyun-Kyu Yoon
  investigator title: Clinical assistant professor