<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/NCT02231528</url>
  </required_header>
  <id_info>
    <org_study_id>1230</org_study_id>
    <nct_id>NCT02231528</nct_id>
  </id_info>
  <brief_title>Interest of Ultrasound Coupled to a Guidance System (GPS) for Central Venous Catheters (CVC) Insertion.</brief_title>
  <acronym>VVC and GPS</acronym>
  <official_title>Interest of Ultrasound Coupled to a Guidance System (GPS) for Central Venous Catheters (CVC) Insertion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The GPS system would simplify the technical implementation of central venous catheter under&#xD;
      ultrasound guidance. We can assume that the introduction of deep venous pathways (as a&#xD;
      reference, the internal jugular) will be faster, and this, whatever the level of expertise.&#xD;
      By checking this hypothesis, this technique could be applied to much less frequent situations&#xD;
      establishment of difficult central venous catheters (hemodynamic status precarious,&#xD;
      hypovolemia, or cardiac arrest).&#xD;
&#xD;
      The main objective of this study is to evaluate the time savings provided by the ultrasound&#xD;
      assisted GPS guidance for installing central venous catheters in the internal jugular.&#xD;
      Central venous catheters are inserted in the operating room under conditions scheduled in&#xD;
      advance that is to say outside emergency. The installation time for the central venous&#xD;
      catheter is compared with that obtained by using the ultrasound machine without the GPS guide&#xD;
      (&quot;conventional&quot; technique).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The techniques of reference for the central venous access (internal jugular, subclavian or&#xD;
      femoral) are based on anatomical landmarks and the low probability of anatomical variations.&#xD;
      With these techniques, the central venous puncture, with Seldinger method, is associated to&#xD;
      complications both in adults and in children (pneumothorax, hemothorax, infection,&#xD;
      thrombosis, arterial puncture, inappropriate location). The frequency of these adverse events&#xD;
      is highly variable and ranges between 1 and 20% of central venous catheters in place.&#xD;
      Ultrasound, visualizing anatomical structures before (echo tracking) or during (ultrasound&#xD;
      guidance) the puncture, improves about 80% the success of the first puncture, and decreases&#xD;
      by 50% the complications. The ultrasound guidance is better than echo tracking to reduce the&#xD;
      time of implementation of the central venous catheter. However, this technique requires more&#xD;
      practice. On the other hand, visualization of the needle path is not always easy especially&#xD;
      for the subclavian access, because it requires a puncture in the ultrasound plane.&#xD;
&#xD;
      GPS system (Guidance Positioning System) is an original system of guidance. This is a simple&#xD;
      navigation system for projecting the theoretical position of the puncture needle in the&#xD;
      ultrasound plane. The guidance system consists of a receiver and two motion sensors. The&#xD;
      receiver is connected to the system. A motion sensor is incorporated into the end of the&#xD;
      needle. Another motion sensor is located within the ultrasound probe. The relative positions&#xD;
      and the axes of the needle and the ultrasound probe are transmitted with coordinates in three&#xD;
      dimensions.&#xD;
&#xD;
      The puncture can be carried out of the plane (ultrasound probe perpendicular to the axis&#xD;
      puncture) and the direct visualization of the needle is not necessary. Before the puncture,&#xD;
      the end of the needle is placed on the skin. The direction and the axis of the needle&#xD;
      relative to the skin are adjusted, before the puncture, depending on the position of the&#xD;
      target to be achieved, displayed by a mark on the screen. Throughout the puncture, a&#xD;
      projected image of the needle is displayed on the screen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 3</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time required for CVC insertion</measure>
    <time_frame>at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of puncture</measure>
    <time_frame>at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate in the superior vena cava territory</measure>
    <time_frame>At 24 hours</time_frame>
    <description>Complication rate secondary to cannulation in the territory superior vena cava: arterial puncture, subcutaneous hematoma, pneumothorax, difficulty progression of the guide, aberrant pathway, transfixion of the vein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insertion failure rate</measure>
    <time_frame>at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure</time_frame>
    <description>Failure is defined as the necessity to change anatomical site despite the visualization of the vein or stop using the GPS function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Use of ultrasound with active GPS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Use of ultrasound with inactive GPS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of ultrasound with active GPS</intervention_name>
    <description>CVC insertion with ultrasound with active GPS function and appropriate needles</description>
    <arm_group_label>Use of ultrasound with active GPS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of ultrasound with inactive GPS</intervention_name>
    <description>CVC insertion with ultrasound with inactive GPS function and conventional needles</description>
    <arm_group_label>Use of ultrasound with inactive GPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 2 sexes&#xD;
&#xD;
          -  Age&gt; 18years&#xD;
&#xD;
          -  Indication for placing a central venous catheter in internal jugular&#xD;
&#xD;
          -  Scheduled installation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons referred to in Articles L. 1121-5 to L. 1121-8 Code of Public Health,&#xD;
&#xD;
          -  Lack of coverage by social security&#xD;
&#xD;
          -  Refusal of patient consent&#xD;
&#xD;
          -  Contraindication for placement of a central venous catheter in internal jugular&#xD;
&#xD;
          -  Emergency&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Doppler data from the supra-aortic trunks if it exists (eg bilateral carotid stenosis)&#xD;
&#xD;
          -  Pacemaker, defibrillator&#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>Pierre ALBALADEJO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Graham AS, Ozment C, Tegtmeyer K, Lai S, Braner DA. Videos in clinical medicine. Central venous catheterization. N Engl J Med. 2007 May 24;356(21):e21. doi: 10.1056/NEJMvcm055053. No abstract available.</citation>
    <PMID>17522396</PMID>
  </reference>
  <reference>
    <citation>Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.</citation>
    <PMID>12919984</PMID>
  </reference>
  <reference>
    <citation>Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.</citation>
    <PMID>8968276</PMID>
  </reference>
  <reference>
    <citation>Hosokawa K, Shime N, Kato Y, Hashimoto S. A randomized trial of ultrasound image-based skin surface marking versus real-time ultrasound-guided internal jugular vein catheterization in infants. Anesthesiology. 2007 Nov;107(5):720-4. doi: 10.1097/01.anes.0000287024.19704.96.</citation>
    <PMID>18073546</PMID>
  </reference>
  <reference>
    <citation>American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.</citation>
    <PMID>22307320</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>June 1, 2015</last_update_submitted>
  <last_update_submitted_qc>June 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>central venous catheter</keyword>
  <keyword>jugular vein</keyword>
  <keyword>ultrasound guidance</keyword>
  <!-- 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/NCT02231528
org study id: 1230
nct id: NCT02231528
lead sponsor: 
has dmc: Yes
The GPS system would simplify the technical implementation of central venous catheter under
      ultrasound guidance. We can assume that the introduction of deep venous pathways (as a
      reference, the internal jugular) will be faster, and this, whatever the level of expertise.
      By checking this hypothesis, this technique could be applied to much less frequent situations
      establishment of difficult central venous catheters (hemodynamic status precarious,
      hypovolemia, or cardiac arrest).

      The main objective of this study is to evaluate the time savings provided by the ultrasound
      assisted GPS guidance for installing central venous catheters in the internal jugular.
      Central venous catheters are inserted in the operating room under conditions scheduled in
      advance that is to say outside emergency. The installation time for the central venous
      catheter is compared with that obtained by using the ultrasound machine without the GPS guide
      ("conventional" technique).
The techniques of reference for the central venous access (internal jugular, subclavian or
      femoral) are based on anatomical landmarks and the low probability of anatomical variations.
      With these techniques, the central venous puncture, with Seldinger method, is associated to
      complications both in adults and in children (pneumothorax, hemothorax, infection,
      thrombosis, arterial puncture, inappropriate location). The frequency of these adverse events
      is highly variable and ranges between 1 and 20% of central venous catheters in place.
      Ultrasound, visualizing anatomical structures before (echo tracking) or during (ultrasound
      guidance) the puncture, improves about 80% the success of the first puncture, and decreases
      by 50% the complications. The ultrasound guidance is better than echo tracking to reduce the
      time of implementation of the central venous catheter. However, this technique requires more
      practice. On the other hand, visualization of the needle path is not always easy especially
      for the subclavian access, because it requires a puncture in the ultrasound plane.

      GPS system (Guidance Positioning System) is an original system of guidance. This is a simple
      navigation system for projecting the theoretical position of the puncture needle in the
      ultrasound plane. The guidance system consists of a receiver and two motion sensors. The
      receiver is connected to the system. A motion sensor is incorporated into the end of the
      needle. Another motion sensor is located within the ultrasound probe. The relative positions
      and the axes of the needle and the ultrasound probe are transmitted with coordinates in three
      dimensions.

      The puncture can be carried out of the plane (ultrasound probe perpendicular to the axis
      puncture) and the direct visualization of the needle is not necessary. Before the puncture,
      the end of the needle is placed on the skin. The direction and the axis of the needle
      relative to the skin are adjusted, before the puncture, depending on the position of the
      target to be achieved, displayed by a mark on the screen. Throughout the puncture, a
      projected image of the needle is displayed on the screen.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Time required for CVC insertion
time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure
measure: Total number of puncture
time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure
measure: Complication rate in the superior vena cava territory
time frame: At 24 hours
description: Complication rate secondary to cannulation in the territory superior vena cava: arterial puncture, subcutaneous hematoma, pneumothorax, difficulty progression of the guide, aberrant pathway, transfixion of the vein
measure: Insertion failure rate
time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure
description: Failure is defined as the necessity to change anatomical site despite the visualization of the vein or stop using the GPS function
arm group label: Use of ultrasound with active GPS
arm group type: Experimental
arm group label: Use of ultrasound with inactive GPS
arm group type: Active Comparator
intervention type: Device
intervention name: Use of ultrasound with active GPS
description: CVC insertion with ultrasound with active GPS function and appropriate needles
arm group label: Use of ultrasound with active GPS
intervention type: Device
intervention name: Use of ultrasound with inactive GPS
description: CVC insertion with ultrasound with inactive GPS function and conventional needles
arm group label: Use of ultrasound with inactive GPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre ALBALADEJO, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
citation: Graham AS, Ozment C, Tegtmeyer K, Lai S, Braner DA. Videos in clinical medicine. Central venous catheterization. N Engl J Med. 2007 May 24;356(21):e21. doi: 10.1056/NEJMvcm055053. No abstract available.
PMID: 17522396
citation: Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
PMID: 12919984
citation: Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.
PMID: 8968276
citation: Hosokawa K, Shime N, Kato Y, Hashimoto S. A randomized trial of ultrasound image-based skin surface marking versus real-time ultrasound-guided internal jugular vein catheterization in infants. Anesthesiology. 2007 Nov;107(5):720-4. doi: 10.1097/01.anes.0000287024.19704.96.
PMID: 18073546
citation: American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.
PMID: 22307320
responsible party type: Sponsor