<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/NCT03784118</url>
  </required_header>
  <id_info>
    <org_study_id>H1812-032-991</org_study_id>
    <nct_id>NCT03784118</nct_id>
  </id_info>
  <brief_title>Complications Associated With Arterial Line Placement in Children</brief_title>
  <official_title>Study on Complications After Arterial Line Placement and the Risk Factors in Children</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>
      The purpose of this study is to find the risk factors for complications following arterial&#xD;
      line catheterization. Ultrasonography is used to evaluate the size of artery which is&#xD;
      cannulated, before and after catheterization. The complications include ischemia, bleeding,&#xD;
      thrombosis and so on.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      artery observation with ultrasound&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of complications associated with arterial catheterization</measure>
    <time_frame>within 5 days after arterial catheterization</time_frame>
    <description>Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age as a risk factor</measure>
    <time_frame>within 5 days after arterial catheterization</time_frame>
    <description>To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts as a risk factor</measure>
    <time_frame>within 5 days after arterial catheterization</time_frame>
    <description>To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of catheterization as a risk factor</measure>
    <time_frame>within 5 days after arterial catheterization</time_frame>
    <description>To evaluate the duration of catheterization as one of the risk factors for complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Complications After Arterial Catheterization</condition>
  <arm_group>
    <arm_group_label>Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <description>Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children</description>
    <arm_group_label>Children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients under 5 years of age who require invasive arterial pressure&#xD;
             monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not need invasive arterial pressure monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Soo Kim Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hee-Soo Kim, PhD</last_name>
    <phone>82-2-2072-3659</phone>
    <email>dami0605@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hee-Soo Kim, MD, Ph.D</last_name>
      <phone>+82-2-2072-3661</phone>
      <email>dami0605@snu.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>Hee-Soo Kim, MD, MS</last_name>
      <phone>+821052878006</phone>
      <email>dami0605@snu.ac.kr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</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>
  <!-- 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/NCT03784118
org study id: H1812-032-991
nct id: NCT03784118
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find the risk factors for complications following arterial
      line catheterization. Ultrasonography is used to evaluate the size of artery which is
      cannulated, before and after catheterization. The complications include ischemia, bleeding,
      thrombosis and so on.
artery observation with ultrasound
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Incidence of complications associated with arterial catheterization
time frame: within 5 days after arterial catheterization
description: Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.
measure: Age as a risk factor
time frame: within 5 days after arterial catheterization
description: To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.
measure: Number of attempts as a risk factor
time frame: within 5 days after arterial catheterization
description: To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications
measure: Duration of catheterization as a risk factor
time frame: within 5 days after arterial catheterization
description: To evaluate the duration of catheterization as one of the risk factors for complications
arm group label: Children
arm group type: Experimental
description: Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography
intervention type: Diagnostic Test
intervention name: Ultrasonography
description: Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children
arm group label: Children
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
last name: Hee-Soo Kim Kim, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Hee-Soo Kim, PhD
phone: 82-2-2072-3659
email: dami0605@snu.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: Professor