<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/NCT02986542</url>
  </required_header>
  <id_info>
    <org_study_id>255</org_study_id>
    <nct_id>NCT02986542</nct_id>
  </id_info>
  <brief_title>Comparison of Success Rates of Femoral Artery Catheterization</brief_title>
  <official_title>Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of USI has eased practical application of interventional procedures, and reduced&#xD;
      complications and procedure durations. For vascular interventions with ultrasound imaging,&#xD;
      short- or long-section imaging of vascular structures is performed. Both techniques have&#xD;
      their own advantages and disadvantages.&#xD;
&#xD;
      This study aims to compare the success rates of femoral artery catheterization using both&#xD;
      imaging techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will include newborns undergoing open heart surgery and patients requiring&#xD;
      arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral&#xD;
      artery cannulation will be randomized with the closed envelope method and separated into two&#xD;
      groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique&#xD;
      (Group B). The intervention will be performed by a single experienced individual. The&#xD;
      preparation duration, puncture duration, number of punctures, number of unsuccessful arterial&#xD;
      punctures, development of hematoma and other complications will be recorded and the groups&#xD;
      will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1.&#xD;
      Patients undergoing KVC surgery and patients requiring arterial catheterization in the&#xD;
      neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic&#xD;
      disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS&#xD;
&#xD;
        1. Local infection&#xD;
&#xD;
        2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)&#xD;
&#xD;
      1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament,&#xD;
      femoral artery diameter, femoral artery and vein location properties 2. Preparation duration,&#xD;
      number of punctures, complications developing during the procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 2, 2018</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Femoral artery catheterization puncture duration</measure>
    <time_frame>1 - 5 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Attempts</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Success of First Attempt</measure>
    <time_frame>1 - 5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of femoral artery to skin</measure>
    <time_frame>1 - 5 minutes</time_frame>
    <description>Distance of femoral artery to skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance of femoral artery to inguinal ligament</measure>
    <time_frame>1 - 5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral artery diameter</measure>
    <time_frame>1 - 5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications developing during the procedure</measure>
    <time_frame>24 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Pulmonary Disease</condition>
  <condition>Electrolyte Disorder</condition>
  <condition>Metabolic Disease</condition>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>USG with the in-plane technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Femoral artery catheterization under USG guidance with the in-plane technique.Patients will have their femoral arterial lines inserted under the guidance of USG. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USG with the out-of-plane technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Under USG guidance femoral artery catheterization will be done with the probe placed for the out-of-plane technique. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral artery catheterization</intervention_name>
    <description>The intervention will be performed by a single experienced individual.</description>
    <arm_group_label>USG with the in-plane technique</arm_group_label>
    <arm_group_label>USG with the out-of-plane technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing KVC surgery and patients requiring arterial catheterization in the&#xD;
             neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders,&#xD;
             metabolic disease, or sepsis requiring frequent blood sampling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Local infection&#xD;
&#xD;
          2. Coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ömer Faruk Boran</last_name>
    <role>Study Chair</role>
    <affiliation>Kahramanmaraş Üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kahramanmaraş Sütçü Imam Üniversity</name>
      <address>
        <city>Kahramanmaraş</city>
        <state>Türkiye</state>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>April 2, 2018</last_update_submitted>
  <last_update_submitted_qc>April 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Ömer Faruk Boran</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>newborns,femoral artery, catheterization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02986542
org study id: 255
nct id: NCT02986542
lead sponsor: 
has dmc: No
The use of USI has eased practical application of interventional procedures, and reduced
      complications and procedure durations. For vascular interventions with ultrasound imaging,
      short- or long-section imaging of vascular structures is performed. Both techniques have
      their own advantages and disadvantages.

      This study aims to compare the success rates of femoral artery catheterization using both
      imaging techniques.
The research will include newborns undergoing open heart surgery and patients requiring
      arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral
      artery cannulation will be randomized with the closed envelope method and separated into two
      groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique
      (Group B). The intervention will be performed by a single experienced individual. The
      preparation duration, puncture duration, number of punctures, number of unsuccessful arterial
      punctures, development of hematoma and other complications will be recorded and the groups
      will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1.
      Patients undergoing KVC surgery and patients requiring arterial catheterization in the
      neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic
      disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS

        1. Local infection

        2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)

      1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament,
      femoral artery diameter, femoral artery and vein location properties 2. Preparation duration,
      number of punctures, complications developing during the procedure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Femoral artery catheterization puncture duration
time frame: 1 - 5 minutes
measure: Number of Attempts
time frame: 5 minutes
measure: Rate of Success of First Attempt
time frame: 1 - 5 minutes
measure: Distance of femoral artery to skin
time frame: 1 - 5 minutes
description: Distance of femoral artery to skin
measure: Distance of femoral artery to inguinal ligament
time frame: 1 - 5 minutes
measure: Femoral artery diameter
time frame: 1 - 5 minutes
measure: Complications developing during the procedure
time frame: 24 hour
arm group label: USG with the in-plane technique
arm group type: Active Comparator
description: Intervention: Femoral artery catheterization under USG guidance with the in-plane technique.Patients will have their femoral arterial lines inserted under the guidance of USG. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD
arm group label: USG with the out-of-plane technique
arm group type: Active Comparator
description: Intervention: Under USG guidance femoral artery catheterization will be done with the probe placed for the out-of-plane technique. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD
intervention type: Procedure
intervention name: Femoral artery catheterization
description: The intervention will be performed by a single experienced individual.
arm group label: USG with the in-plane technique
arm group label: USG with the out-of-plane technique
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Ömer Faruk Boran
role: Study Chair
affiliation: Kahramanmaraş Üniversitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Ömer Faruk Boran
investigator title: Assistant Professor
mesh term: Metabolic Diseases
sharing ipd: No