<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/NCT03289767</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_angulation</org_study_id>
    <nct_id>NCT03289767</nct_id>
  </id_info>
  <brief_title>Simple Preparation of Endotracheal Tube</brief_title>
  <official_title>Simple Preparation of Endotracheal Tube for Optimal Angulation During Intubation: A Randomized Controlled Trial</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>
      To observe the effect of additional E-tube angulation on intubation time and success rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis of this study is that shaping endotracheal tube by end-to-end connection&#xD;
      before induction will provide more optimal angulation for endotracheal intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">May 10, 2018</completion_date>
  <primary_completion_date type="Actual">May 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful intubation on first attempt</measure>
    <time_frame>On endotracheal intubation up to 1 min</time_frame>
    <description>Whether successful intubation is done on first attempt or on additional attempt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to intubate (TIT)</measure>
    <time_frame>On endotracheal intubation up to 1 min</time_frame>
    <description>The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Endotracheal Tube</condition>
  <arm_group>
    <arm_group_label>Curved-tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Giving additional curve to the endotracheal tube by simple preparation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No other manipulation of the endotracheal tube is done.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Curved-tube</intervention_name>
    <description>Connecting both ends of the endotracheal tube (&quot;O&quot; shape) for 5-min and releasing it provides additional anterior angle temporarily.</description>
    <arm_group_label>Curved-tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for elective surgery requiring general anesthesia and&#xD;
             tracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with congenital or acquired upper airway lesions&#xD;
&#xD;
          -  Patients with high risk of aspiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong-Hwa Seo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-Hwa Seo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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/NCT03289767
org study id: JHSeo_angulation
nct id: NCT03289767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To observe the effect of additional E-tube angulation on intubation time and success rate.
The hypothesis of this study is that shaping endotracheal tube by end-to-end connection
      before induction will provide more optimal angulation for endotracheal intubation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Successful intubation on first attempt
time frame: On endotracheal intubation up to 1 min
description: Whether successful intubation is done on first attempt or on additional attempt
measure: Time to intubate (TIT)
time frame: On endotracheal intubation up to 1 min
description: The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace
arm group label: Curved-tube
arm group type: Experimental
description: Giving additional curve to the endotracheal tube by simple preparation.
arm group label: Control
arm group type: No Intervention
description: No other manipulation of the endotracheal tube is done.
intervention type: Other
intervention name: Curved-tube
description: Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.
arm group label: Curved-tube
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeong-Hwa Seo, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor