<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/NCT02975622</url>
  </required_header>
  <id_info>
    <org_study_id>HCPA001</org_study_id>
    <nct_id>NCT02975622</nct_id>
  </id_info>
  <brief_title>Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial</brief_title>
  <acronym>USCATH</acronym>
  <official_title>Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial Comparing Jugular and Subclavian Approaches</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nossa Senhora da Conceicao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Nossa Senhora da Conceicao</source>
  <brief_summary>
    <textblock>
      Ultrasound (US)-guided central venous catheterization is now considered standard of care&#xD;
      according to recent clinical evidence, at least considering jugular vein approach. Recent&#xD;
      trials suggested that even US-guided subclavian approach could be more effective that&#xD;
      landmark technique. However, studies comparing both sites employing US are still lacking.&#xD;
&#xD;
      We, therefore, designed a non-inferiority randomized controlled trial to compare these sites,&#xD;
      both using US guidance, according to immediate complications following central venous&#xD;
      catheterization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <primary_completion_date type="Anticipated">December 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immediate complications</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Catheterization, Central Venous</condition>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>Subclavian</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subclavian vein will be individualized and approached by longitudinal incidence, according to previous studies. Skin puncture will be made next to the transducer, lateral to the first rib, maintaining constant visualization of the needle tip.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jugular</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Jugular vein will be identified by transverse or longitudinal approach, and skin puncture will be made by transverse or longitudinal incidence, according to operator's preferences. Using transverse approach, the needle will be maintained in a 45 degree angle with the skin, and the insertion site will be exactly the same as the measured distance between asking and jugular vein wall.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Central venous catheterization</intervention_name>
    <description>Ultrasound guided central venous catheterization</description>
    <arm_group_label>Jugular</arm_group_label>
    <arm_group_label>Subclavian</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critically ill patients; central venous access indicated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac arrest; at least one side of each vein available for insertion; pacemaker&#xD;
             insertion; pulmonary artery catheter insertion; non-corrected coagulopathy;&#xD;
             thrombolytics in the past 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Augusto Santos Pellegrini, MD</last_name>
      <phone>555133598537</phone>
      <email>joseaugusto.pellegrini@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rafael Barberena Moraes, PhD</last_name>
      <phone>555133598639</phone>
      <email>moraesrb@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Nossa Senhora da Conceicao</investigator_affiliation>
    <investigator_full_name>Jose Augusto Santos Pellegrini</investigator_full_name>
    <investigator_title>MD</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/NCT02975622
org study id: HCPA001
nct id: NCT02975622
lead sponsor: 
collaborator: 
Ultrasound (US)-guided central venous catheterization is now considered standard of care
      according to recent clinical evidence, at least considering jugular vein approach. Recent
      trials suggested that even US-guided subclavian approach could be more effective that
      landmark technique. However, studies comparing both sites employing US are still lacking.

      We, therefore, designed a non-inferiority randomized controlled trial to compare these sites,
      both using US guidance, according to immediate complications following central venous
      catheterization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Immediate complications
time frame: 24 hours
arm group label: Subclavian
arm group type: Active Comparator
description: Subclavian vein will be individualized and approached by longitudinal incidence, according to previous studies. Skin puncture will be made next to the transducer, lateral to the first rib, maintaining constant visualization of the needle tip.
arm group label: Jugular
arm group type: Active Comparator
description: Jugular vein will be identified by transverse or longitudinal approach, and skin puncture will be made by transverse or longitudinal incidence, according to operator's preferences. Using transverse approach, the needle will be maintained in a 45 degree angle with the skin, and the insertion site will be exactly the same as the measured distance between asking and jugular vein wall.
intervention type: Procedure
intervention name: Central venous catheterization
description: Ultrasound guided central venous catheterization
arm group label: Jugular
arm group label: Subclavian
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Nossa Senhora da Conceicao
investigator full name: Jose Augusto Santos Pellegrini
investigator title: MD