<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/NCT03303274</url>
  </required_header>
  <id_info>
    <org_study_id>1707-110-871-2</org_study_id>
    <nct_id>NCT03303274</nct_id>
  </id_info>
  <brief_title>A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage II</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 second stage of this study, the investigators would like to compare the success rate,&#xD;
      the number of needle passage, time to complete subclavian vein catheterization in supine and&#xD;
      ipsilateral tile 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 20, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of needle passage</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>The number of needle passage for puncture of subclavian vein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to puncture subclavian vein</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>Time to puncture subclavian vein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to insert guidewire</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>Time to insert guidewire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to insert dilator</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>Time to insert dilator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of trial to insert catheter</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>The number of trial to insert catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to insert catheter</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>Time to insert catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of catheter insertion</measure>
    <time_frame>during subclavian venous catheterization</time_frame>
    <description>Final success of catheter insertion within 6 trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other complications with central venous catheterization</measure>
    <time_frame>From subclavian venous catheterization to 24 hours after operation finished</time_frame>
    <description>complications with central venous catheterization such as arterial puncture, perivascular hematoma, pneumothorax, and malpositioning</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</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>The operation table will be tilted 20 degrees right laterally before subclavian venous catheterization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Catheterization of right subclavian vein in supine position.</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>
  <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>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 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/NCT03303274
org study id: 1707-110-871-2
nct id: NCT03303274
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 second stage of this study, the investigators would like to compare the success rate,
      the number of needle passage, time to complete subclavian vein catheterization in supine and
      ipsilateral tile position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The number of needle passage
time frame: during subclavian venous catheterization
description: The number of needle passage for puncture of subclavian vein
measure: Time to puncture subclavian vein
time frame: during subclavian venous catheterization
description: Time to puncture subclavian vein
measure: Time to insert guidewire
time frame: during subclavian venous catheterization
description: Time to insert guidewire
measure: Time to insert dilator
time frame: during subclavian venous catheterization
description: Time to insert dilator
measure: The number of trial to insert catheter
time frame: during subclavian venous catheterization
description: The number of trial to insert catheter
measure: Time to insert catheter
time frame: during subclavian venous catheterization
description: Time to insert catheter
measure: Success of catheter insertion
time frame: during subclavian venous catheterization
description: Final success of catheter insertion within 6 trials
measure: Other complications with central venous catheterization
time frame: From subclavian venous catheterization to 24 hours after operation finished
description: complications with central venous catheterization such as arterial puncture, perivascular hematoma, pneumothorax, and malpositioning
arm group label: Ipsilateral tilt
arm group type: Experimental
description: The operation table will be tilted 20 degrees right laterally before subclavian venous catheterization.
arm group label: Supine
arm group type: No Intervention
description: Catheterization of right subclavian vein in supine position.
intervention type: Procedure
intervention name: Ipsilateral tilt
description: The operation table will be tilted 20 degrees right laterally.
arm group label: Ipsilateral 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