<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/NCT03812757</url>
  </required_header>
  <id_info>
    <org_study_id>CVC positioning</org_study_id>
    <nct_id>NCT03812757</nct_id>
  </id_info>
  <brief_title>Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization</brief_title>
  <official_title>The Supraclavicular Fossa Ultrasound View for Correct Catheter Positioning in Infraclavicular Right Subclavian Central Venous Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skane University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Skane University Hospital</source>
  <oversight_info>
    <has_dmc>No</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 study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a&#xD;
      correct catheter tip placement in infraclavicular right subclavian central venous catheter&#xD;
      placement. This may make routine post-procedural x-ray exams redundant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central venous catheterization is one of the most common procedures within intensive care&#xD;
      medicine. Verification of correct catheter tip placement is a primary aspect of safety and&#xD;
      quality of central venous catheterization as malposition may lead to life-threatening&#xD;
      complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias.&#xD;
      Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered&#xD;
      gold standard to examine catheter tip location and evaluate for complications such as pneumo-&#xD;
      and hemothorax. However, CXR exposes the patient to ionized radiation, requires a&#xD;
      considerable amount of time, and is workload-generating for both ICU and radiology staff.&#xD;
&#xD;
      Weber et al has described the use of the right supraclavicular fossa view for real-time&#xD;
      ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular&#xD;
      vein (IJV) in adults. This approach has subsequently been validated in a clinical study and&#xD;
      has also been used for supraclavicular subclavian line insertion. The approach requires use&#xD;
      of a microconvex probe, which couples good image resolution and high scanning depth. The use&#xD;
      of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion&#xD;
      has been described previously, but this is the first description of the supraclavicular fossa&#xD;
      ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian&#xD;
      CVC placement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Correct catheter tip positioning</measure>
    <time_frame>Post-procedural x-ray (typically within 24 hours)</time_frame>
    <description>Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanical complications within 24 hours</measure>
    <time_frame>Within 24 hours after central venous catheterization</time_frame>
    <description>Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Central Venous Catheter Placement</condition>
  <arm_group>
    <arm_group_label>Supraclavicular fossa US scanning</arm_group_label>
    <description>Following insertion of at least 20 cm of the guidewire into the right subclavian vein, the probe is shifted to the right supraclavicular fossa to scan the right internal jugular vein in order to exclude malposition of the guidewire. The probe is then tilted in a caudal direction to obtain a view of the guidewire within the superior vena cava. Misplaced guidewires will be corrected under real-time ultrasound guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Supraclavicular fossa US scanning</intervention_name>
    <description>As previously stated.</description>
    <arm_group_label>Supraclavicular fossa US scanning</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt;18 years with an indication for CVC placement and under the care of one of three&#xD;
        intensivists responsible for the study will be consecutively included in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for central venous catheter placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous&#xD;
             emphysema of the chest wall),&#xD;
&#xD;
          -  Subclavian vein catheterization deemed inappropriate by the operator,&#xD;
&#xD;
          -  Central line/pacemaker/similar device already in place (risk for misinterpretation of&#xD;
             the ultrasound image)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ola Borgquist, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skane University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skånes universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>November 1, 2020</last_update_submitted>
  <last_update_submitted_qc>November 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Skane University Hospital</investigator_affiliation>
    <investigator_full_name>Ola Borgquist</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Central venous catheter</keyword>
  <keyword>Subclavian vein</keyword>
  <keyword>Supraclavicular fossa ultrasound view</keyword>
  <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/NCT03812757
org study id: CVC positioning
nct id: NCT03812757
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a
      correct catheter tip placement in infraclavicular right subclavian central venous catheter
      placement. This may make routine post-procedural x-ray exams redundant.
Central venous catheterization is one of the most common procedures within intensive care
      medicine. Verification of correct catheter tip placement is a primary aspect of safety and
      quality of central venous catheterization as malposition may lead to life-threatening
      complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias.
      Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered
      gold standard to examine catheter tip location and evaluate for complications such as pneumo-
      and hemothorax. However, CXR exposes the patient to ionized radiation, requires a
      considerable amount of time, and is workload-generating for both ICU and radiology staff.

      Weber et al has described the use of the right supraclavicular fossa view for real-time
      ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular
      vein (IJV) in adults. This approach has subsequently been validated in a clinical study and
      has also been used for supraclavicular subclavian line insertion. The approach requires use
      of a microconvex probe, which couples good image resolution and high scanning depth. The use
      of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion
      has been described previously, but this is the first description of the supraclavicular fossa
      ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian
      CVC placement.
observational model: Cohort
time perspective: Prospective
measure: Correct catheter tip positioning
time frame: Post-procedural x-ray (typically within 24 hours)
description: Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).
measure: Mechanical complications within 24 hours
time frame: Within 24 hours after central venous catheterization
description: Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.
arm group label: Supraclavicular fossa US scanning
description: Following insertion of at least 20 cm of the guidewire into the right subclavian vein, the probe is shifted to the right supraclavicular fossa to scan the right internal jugular vein in order to exclude malposition of the guidewire. The probe is then tilted in a caudal direction to obtain a view of the guidewire within the superior vena cava. Misplaced guidewires will be corrected under real-time ultrasound guidance.
intervention type: Diagnostic Test
intervention name: Supraclavicular fossa US scanning
description: As previously stated.
arm group label: Supraclavicular fossa US scanning
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ola Borgquist, MD, PhD
role: Principal Investigator
affiliation: Skane University Hospital
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Skane University Hospital
investigator full name: Ola Borgquist
investigator title: Principal investigator
sharing ipd: No