<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/NCT03025178</url>
  </required_header>
  <id_info>
    <org_study_id>H1701-038-821</org_study_id>
    <nct_id>NCT03025178</nct_id>
  </id_info>
  <brief_title>Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants</brief_title>
  <official_title>External Validation of Predictive Formula for Optimal Insertion Depth of Left Internal Jugular Venous Catheter in Infants</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>Yes</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>
      We previously performed a study to create formula for the optimal insertion depth of left&#xD;
      internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found&#xD;
      that two calculation methods using height and the distance between landmarks (0.11 × height&#xD;
      (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the&#xD;
      most prominent point of the sternal head of the left clavicle, and B was the midpoint of the&#xD;
      perpendicular line drawn between the sternal head of the right clavicle and an imaginary line&#xD;
      between the nipples) were clinically feasible to determine the insertion depth of left&#xD;
      internal jugular vein catheter. In this study, we will compare the actual insertion depth&#xD;
      with the insertion depth determined from above two calculation methods in other 46 infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      determine the optimal insertion depth of left internal jugular vein catheter in infants&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The actual insertion depth of central venous catheter</measure>
    <time_frame>About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)</time_frame>
    <description>The actual insertion depth of central venous catheter placed at left internal jugular vein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods</measure>
    <time_frame>About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)</time_frame>
    <description>The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Central Venous Catheter</condition>
  <condition>Infant</condition>
  <arm_group>
    <arm_group_label>Central venous catheterization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Central venous catheterization will be performed using 4Fr central venous catheter at left internal jugular vein in infant. The tip of central venous catheter will be confirmed by transthoracic echocardiography. The actual insertion depth of central venous catheter will be compared to the predicted insertion depth derived from two calculation methods using height and the distance between the anatomical landmarks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>4Fr central venous catheter insertion</intervention_name>
    <description>The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.</description>
    <arm_group_label>Central venous catheterization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An infant requiring a central venous catheter during surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extracardiac vascular anomaly&#xD;
&#xD;
          -  Dextrocardia&#xD;
&#xD;
          -  Anatomical abnormality in neck and thorax&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Soo Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SNUH</name>
      <address>
        <city>Seoul</city>
        <state>Jongro Gu</state>
        <zip>15710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</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-Soo Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025178
org study id: H1701-038-821
nct id: NCT03025178
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We previously performed a study to create formula for the optimal insertion depth of left
      internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found
      that two calculation methods using height and the distance between landmarks (0.11 × height
      (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the
      most prominent point of the sternal head of the left clavicle, and B was the midpoint of the
      perpendicular line drawn between the sternal head of the right clavicle and an imaginary line
      between the nipples) were clinically feasible to determine the insertion depth of left
      internal jugular vein catheter. In this study, we will compare the actual insertion depth
      with the insertion depth determined from above two calculation methods in other 46 infants.
determine the optimal insertion depth of left internal jugular vein catheter in infants
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The actual insertion depth of central venous catheter
time frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
description: The actual insertion depth of central venous catheter placed at left internal jugular vein
measure: The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
time frame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
description: The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
arm group label: Central venous catheterization
arm group type: Experimental
description: Central venous catheterization will be performed using 4Fr central venous catheter at left internal jugular vein in infant. The tip of central venous catheter will be confirmed by transthoracic echocardiography. The actual insertion depth of central venous catheter will be compared to the predicted insertion depth derived from two calculation methods using height and the distance between the anatomical landmarks.
intervention type: Procedure
intervention name: 4Fr central venous catheter insertion
description: The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.
arm group label: Central venous catheterization
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: Accepts Healthy Volunteers
last name: Hee-Soo Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: Professor
sharing ipd: Undecided