<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/NCT03296735</url>
  </required_header>
  <id_info>
    <org_study_id>2017-110-871-1</org_study_id>
    <nct_id>NCT03296735</nct_id>
  </id_info>
  <brief_title>A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I</brief_title>
  <official_title>A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central venous catheterization is widely used for various purposes during surgery. For&#xD;
      central venous catheterization, subclavian vein is selected because of the relatively low&#xD;
      risk of infection, long-term patency and low patient discomfort. The cross - sectional area&#xD;
      of the subclavian vein is an important factor to increase success rate. Several studies have&#xD;
      reported that the Trendelenburg position increases the cross-sectional area of the subclavian&#xD;
      vein, and the lateral tilt position can change the cross-sectional area of the subclavian&#xD;
      vein. However, the impact of lateral tilt position to the cross-sectional area of the&#xD;
      subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area&#xD;
      of the subclavian vein, and the contralateral position can decrease the cross-sectional area&#xD;
      by gravity.&#xD;
&#xD;
      In the first stage of this study, we compare the cross-sectional area of subclavian vein&#xD;
      using ultrasonography in supine, ipsilateral, and contralateral tilt position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 15, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The cross-sectional area of right subclavian vein</measure>
    <time_frame>1 minutes after position change</time_frame>
    <description>The cross-sectional area of right subclavian vein</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Catheterization</condition>
  <condition>Posture</condition>
  <arm_group>
    <arm_group_label>Ipsilateral tilt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Measuring the cross-sectional area of right subclavian vein in supine position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contralateral tilt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ipsilateral tilt</intervention_name>
    <description>The operation table will be tilted 20 degrees right laterally.</description>
    <arm_group_label>Ipsilateral tilt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Contralateral tilt</intervention_name>
    <description>The operation table will be tilted 20 degrees left laterally.</description>
    <arm_group_label>Contralateral tilt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - the patients who receive elective neurosurgical surgery and require central venous&#xD;
        catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patients who have puncture site infection&#xD;
&#xD;
          -  the patients who have chemoport, pacemaker in right subclavian vein&#xD;
&#xD;
          -  the patients who had received right mastectomy or right pneumonectomy&#xD;
&#xD;
          -  other contraindications for subclavian venous catheterization (eg. mass, hematoma,&#xD;
             vegetation, and anticoagulation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyung-Chul Lee, MD</last_name>
    <phone>+82-10-2456-6336</phone>
    <email>lucid80@gmail.com</email>
  </overall_contact>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hee-Pyoung Park</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/NCT03296735
org study id: 2017-110-871-1
nct id: NCT03296735
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Central venous catheterization is widely used for various purposes during surgery. For
      central venous catheterization, subclavian vein is selected because of the relatively low
      risk of infection, long-term patency and low patient discomfort. The cross - sectional area
      of the subclavian vein is an important factor to increase success rate. Several studies have
      reported that the Trendelenburg position increases the cross-sectional area of the subclavian
      vein, and the lateral tilt position can change the cross-sectional area of the subclavian
      vein. However, the impact of lateral tilt position to the cross-sectional area of the
      subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area
      of the subclavian vein, and the contralateral position can decrease the cross-sectional area
      by gravity.

      In the first stage of this study, we compare the cross-sectional area of subclavian vein
      using ultrasonography in supine, ipsilateral, and contralateral tilt position.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The cross-sectional area of right subclavian vein
time frame: 1 minutes after position change
description: The cross-sectional area of right subclavian vein
arm group label: Ipsilateral tilt
arm group type: Experimental
description: Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
arm group label: Supine
arm group type: No Intervention
description: Measuring the cross-sectional area of right subclavian vein in supine position.
arm group label: Contralateral tilt
arm group type: Active Comparator
description: Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
intervention type: Procedure
intervention name: Ipsilateral tilt
description: The operation table will be tilted 20 degrees right laterally.
arm group label: Ipsilateral tilt
intervention type: Procedure
intervention name: Contralateral tilt
description: The operation table will be tilted 20 degrees left laterally.
arm group label: Contralateral tilt
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Hyung-Chul Lee, MD
phone: +82-10-2456-6336
email: lucid80@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Pyoung Park
investigator title: Professor