<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/NCT04463147</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2019/AC-01</org_study_id>
    <nct_id>NCT04463147</nct_id>
  </id_info>
  <brief_title>Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique</brief_title>
  <acronym>NEEDLE-VISIO</acronym>
  <official_title>Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      Real-time ultrasound guidance for central venous catheter catheterism is recommended in order&#xD;
      to reduce complication, in particular for internal jugular site1. Nevertheless, the&#xD;
      usefulness of ultrasound guidance for subclavian approach remains controversial, in&#xD;
      particular because needle visualisation is more complex as compared to jugular site2,3. New&#xD;
      magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a&#xD;
      better needle visualisation and a better success rate. The investigators hypothesize that&#xD;
      such device could improve the feasibility of subclavian catheterism. As this device has not&#xD;
      been evaluated in patients, the investigators decided to perform a simulation study on a&#xD;
      human torso mannequin. This methodology has been already used by Vogel et al in 20154. The&#xD;
      main objective aims to compare the procedure time between conventional real time ultrasound&#xD;
      guidance and guidance with Needle-pilot™ device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First puncture success delay</measure>
    <time_frame>during the procedure</time_frame>
    <description>comparison of time (in seconds) between first puncture and successful &quot;blood-aspiration&quot; on a &quot;subclavian venous&quot; torso mannequin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure Rate</measure>
    <time_frame>during the procedure</time_frame>
    <description>Failure is defined as a puncture time &gt; 300 seconds. The criterion corresponds to an absolute value: failure or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cutaneous wall</measure>
    <time_frame>during the procedure</time_frame>
    <description>Counting the number of times each participant will puncture the wall of the mannequin before succeeding in puncturing the vessel with the 2 techniques and comparing this number between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posterior wall</measure>
    <time_frame>during the procedure</time_frame>
    <description>Number of posterior vessel wall penetration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puncture comfort</measure>
    <time_frame>immediately after the procedure</time_frame>
    <description>Operator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Central Venous Catheters</condition>
  <condition>Ultrasound Guidance</condition>
  <arm_group>
    <arm_group_label>new residents</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>new residents in ultrasound-guided central vascular catheterization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experienced residents or ICU practitioners</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Needle-pilotTM device</intervention_name>
    <description>The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.</description>
    <arm_group_label>experienced residents or ICU practitioners</arm_group_label>
    <arm_group_label>new residents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • all residents and practicioners of intensive care units in the Nîmes University Hospital,&#xD;
        France.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • unavailability or operator refusal, and more than one year without subclavian central&#xD;
        catheterization (for experienced subgroup).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nîmes, Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.</citation>
    <PMID>25575245</PMID>
  </reference>
  <reference>
    <citation>Jiang L, Zhang M, Ma Y. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis: Several Facts Need To Be Noticed. Crit Care Med. 2015 Oct;43(10):e474-5. doi: 10.1097/CCM.0000000000001071. No abstract available.</citation>
    <PMID>26376279</PMID>
  </reference>
  <reference>
    <citation>Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823.</citation>
    <PMID>25517477</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Catheterization</keyword>
  <keyword>Subclavian Vein</keyword>
  <keyword>Vascular Access Devices</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/NCT04463147
org study id: LOCAL/2019/AC-01
nct id: NCT04463147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Real-time ultrasound guidance for central venous catheter catheterism is recommended in order
      to reduce complication, in particular for internal jugular site1. Nevertheless, the
      usefulness of ultrasound guidance for subclavian approach remains controversial, in
      particular because needle visualisation is more complex as compared to jugular site2,3. New
      magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a
      better needle visualisation and a better success rate. The investigators hypothesize that
      such device could improve the feasibility of subclavian catheterism. As this device has not
      been evaluated in patients, the investigators decided to perform a simulation study on a
      human torso mannequin. This methodology has been already used by Vogel et al in 20154. The
      main objective aims to compare the procedure time between conventional real time ultrasound
      guidance and guidance with Needle-pilot™ device.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: First puncture success delay
time frame: during the procedure
description: comparison of time (in seconds) between first puncture and successful "blood-aspiration" on a "subclavian venous" torso mannequin.
measure: Failure Rate
time frame: during the procedure
description: Failure is defined as a puncture time > 300 seconds. The criterion corresponds to an absolute value: failure or not
measure: Cutaneous wall
time frame: during the procedure
description: Counting the number of times each participant will puncture the wall of the mannequin before succeeding in puncturing the vessel with the 2 techniques and comparing this number between groups.
measure: Posterior wall
time frame: during the procedure
description: Number of posterior vessel wall penetration
measure: Puncture comfort
time frame: immediately after the procedure
description: Operator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.
arm group label: new residents
arm group type: Other
description: new residents in ultrasound-guided central vascular catheterization.
arm group label: experienced residents or ICU practitioners
arm group type: Other
description: experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization.
intervention type: Device
intervention name: Needle-pilotTM device
description: The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.
arm group label: experienced residents or ICU practitioners
arm group label: new residents
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
citation: Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.
PMID: 25575245
citation: Jiang L, Zhang M, Ma Y. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis: Several Facts Need To Be Noticed. Crit Care Med. 2015 Oct;43(10):e474-5. doi: 10.1097/CCM.0000000000001071. No abstract available.
PMID: 26376279
citation: Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823.
PMID: 25517477
responsible party type: Sponsor
sharing ipd: No