<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/NCT01685866</url>
  </required_header>
  <id_info>
    <org_study_id>SC/DM_JDS_2012-1_V1.0-20120605</org_study_id>
    <nct_id>NCT01685866</nct_id>
  </id_info>
  <brief_title>3V- Improve Venous Access in Pediatric Anesthesia</brief_title>
  <acronym>3V</acronym>
  <official_title>Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral&#xD;
      veins in children having forecasted difficult venous access and could facilitate the venous&#xD;
      access.The main goal is to reduce the time necessary to get a venous access during the&#xD;
      inhalation anesthesia induction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized study comparing the delay of peripheral access with or without using the device.&#xD;
      Monosite study, including children undergoing surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduce the time necessary to find the venous access during inhalation anesthesia induction</measure>
    <time_frame>1 day of anesthesia</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Vein-Viewer Vision</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A medical device called Vein-Viewer Vision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no medical device</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>in the second arm, we use no medical device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vein-Viewer Vision</intervention_name>
    <description>A medical device called Vein-Viewer Vision</description>
    <arm_group_label>Vein-Viewer Vision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children aged less than 7&#xD;
&#xD;
          -  DIVA score ≥ 4&#xD;
&#xD;
          -  patient needing venous peripheral access for general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no social security&#xD;
&#xD;
          -  opposition of the parent(s) to the participation of their child in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Michel Devys, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique Adolphe de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Debré Hospital, APHP</name>
      <address>
        <city>Paris</city>
        <state>Ile de France</state>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation ophtalmologique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>venous access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01685866
org study id: SC/DM_JDS_2012-1_V1.0-20120605
nct id: NCT01685866
lead sponsor: 
collaborator: 
has dmc: No
Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral
      veins in children having forecasted difficult venous access and could facilitate the venous
      access.The main goal is to reduce the time necessary to get a venous access during the
      inhalation anesthesia induction.
Randomized study comparing the delay of peripheral access with or without using the device.
      Monosite study, including children undergoing surgery.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: reduce the time necessary to find the venous access during inhalation anesthesia induction
time frame: 1 day of anesthesia
arm group label: Vein-Viewer Vision
arm group type: Other
description: A medical device called Vein-Viewer Vision
arm group label: no medical device
arm group type: No Intervention
description: in the second arm, we use no medical device
intervention type: Device
intervention name: Vein-Viewer Vision
description: A medical device called Vein-Viewer Vision
arm group label: Vein-Viewer Vision
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
healthy volunteers: No
last name: Jean-Michel Devys, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Cardiovascular Diseases