<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/NCT03790241</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0533</org_study_id>
    <secondary_id>2018-A02895-50</secondary_id>
    <nct_id>NCT03790241</nct_id>
  </id_info>
  <brief_title>In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion</brief_title>
  <acronym>ABGPVVP</acronym>
  <official_title>In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 aim of this study is to analyze the palpation and perforation motion performed by the&#xD;
      practitioner during the insertion of a catheter while measuring the loads applied on the skin&#xD;
      and the veins.&#xD;
&#xD;
      These experimental measures will be used for the design of a more realistic peripheral venous&#xD;
      catheter insertion simulator in order to better prepare healthcare students for their first&#xD;
      in vivo venous puncture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 25, 2019</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Punctures forces of the skin and veins measured by an instrumented syringue</measure>
    <time_frame>Day 0 (at intervention)</time_frame>
    <description>According to the literature, puncture forces of soft tissues are decomposed as a summation of stiffness forces, friction forces and cutting forces. In the case of this study, an instrumented syringe has been designed to measure the puncture force in function of time. This device includes a miniature1-axis load sensor. The catheters can be easily removed thanks to a conical fitting which is directly connected to the load sensor to obtain the forces when inserting and withdrawing the catheter.&#xD;
The primary sought measures are the peak force occurring when penetrating the skin and the vein as well as the friction forces when withdrawing the catheter from the vein.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Needle velocity during perforation measured by a flexible piezoresistive sensor</measure>
    <time_frame>Day 0</time_frame>
    <description>In order to obtain the load applied by the practitioner to locate the vein to puncture, a flexible piezoresistive sensor is placed to the practitioner's fingertip with double side tape The sensor is linked to its acquisition module which is connected via Wi-Fi to a computer.&#xD;
In order to not disturb the motion of the practitioner, the module if fixed with a sport armband to the forearm.&#xD;
The primary sought measure is the curve force in function of time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Needle insertion angle during perforation measured by digital image correlation</measure>
    <time_frame>Day 0</time_frame>
    <description>obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlation</measure>
    <time_frame>Day 0</time_frame>
    <description>obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial displacement of the palpating finger measured by digital image correlation</measure>
    <time_frame>Day 0</time_frame>
    <description>obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>Day 0</time_frame>
    <description>to evaluate the Influence of age regarding the puncture forces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sex</measure>
    <time_frame>Day 0</time_frame>
    <description>to evaluate the Influence of sex regarding the puncture forces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Day 0</time_frame>
    <description>to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Day 0</time_frame>
    <description>to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Young males of normal corpulence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young females of normal corpulence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aged males of normal corpulence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aged females of normal corpulence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese young males</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese young females</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese aged males</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese aged females</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>insertion of a catheter</intervention_name>
    <description>Analysis the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins</description>
    <arm_group_label>Aged females of normal corpulence</arm_group_label>
    <arm_group_label>Aged males of normal corpulence</arm_group_label>
    <arm_group_label>Obese aged females</arm_group_label>
    <arm_group_label>Obese aged males</arm_group_label>
    <arm_group_label>Obese young females</arm_group_label>
    <arm_group_label>Obese young males</arm_group_label>
    <arm_group_label>Young females of normal corpulence</arm_group_label>
    <arm_group_label>Young males of normal corpulence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult volunteer&#xD;
&#xD;
          -  Aged between 18-25 yo or 60-75 yo&#xD;
&#xD;
          -  IBM between 18,5-25 or superior or equal to 30&#xD;
&#xD;
          -  Cognitive level compatible with oral communication, respect of safety instructions and&#xD;
             understanding of realized acts&#xD;
&#xD;
          -  Signed the study agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals displaying coagulation disorders&#xD;
&#xD;
          -  Individuals displaying skin lesions, scars or areteriovenous fistula on the ventral&#xD;
             side of the forearm&#xD;
&#xD;
          -  Individuals displaying a high infection risk&#xD;
&#xD;
          -  Women that have been subject to a lymph node dissection on a malignant breast tumor&#xD;
&#xD;
          -  Individuals not able to express their consent&#xD;
&#xD;
          -  Individuals having a hierarchical link with the persons conducting this study&#xD;
&#xD;
          -  Individuals currently participating to another research which includes an exclusion&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anthony Viste</last_name>
    <phone>4 78 86 37 38</phone>
    <phone_ext>+33</phone_ext>
    <email>anthony.viste@univ-lyon1.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kevin Torossian</last_name>
    <email>kevin.torossian@ifsttar.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony VISTE</last_name>
      <phone>4 78 86 37 38</phone>
      <phone_ext>+33</phone_ext>
      <email>anthony.viste@univ-lyon1.fr</email>
    </contact>
    <contact_backup>
      <last_name>Kevin Torossian</last_name>
      <email>kevin.torossian@ifsttar.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Anthony VISTE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheter insertion</keyword>
  <keyword>puncture</keyword>
  <keyword>skin</keyword>
  <keyword>vein</keyword>
  <keyword>palpation</keyword>
  <keyword>motion tracking</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/NCT03790241
org study id: 69HCL18_0533
secondary id: 2018-A02895-50
nct id: NCT03790241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to analyze the palpation and perforation motion performed by the
      practitioner during the insertion of a catheter while measuring the loads applied on the skin
      and the veins.

      These experimental measures will be used for the design of a more realistic peripheral venous
      catheter insertion simulator in order to better prepare healthcare students for their first
      in vivo venous puncture.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Punctures forces of the skin and veins measured by an instrumented syringue
time frame: Day 0 (at intervention)
description: According to the literature, puncture forces of soft tissues are decomposed as a summation of stiffness forces, friction forces and cutting forces. In the case of this study, an instrumented syringe has been designed to measure the puncture force in function of time. This device includes a miniature1-axis load sensor. The catheters can be easily removed thanks to a conical fitting which is directly connected to the load sensor to obtain the forces when inserting and withdrawing the catheter.
The primary sought measures are the peak force occurring when penetrating the skin and the vein as well as the friction forces when withdrawing the catheter from the vein.
measure: Needle velocity during perforation measured by a flexible piezoresistive sensor
time frame: Day 0
description: In order to obtain the load applied by the practitioner to locate the vein to puncture, a flexible piezoresistive sensor is placed to the practitioner's fingertip with double side tape The sensor is linked to its acquisition module which is connected via Wi-Fi to a computer.
In order to not disturb the motion of the practitioner, the module if fixed with a sport armband to the forearm.
The primary sought measure is the curve force in function of time.
measure: Needle insertion angle during perforation measured by digital image correlation
time frame: Day 0
description: obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
measure: Loads applied by the palpating finger to locate the vein to puncture, measured by digital image correlation
time frame: Day 0
description: obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
measure: Spatial displacement of the palpating finger measured by digital image correlation
time frame: Day 0
description: obtained thanks to digital image correlation which consists of tracking sights with two high speed cameras. Thus, sights will be placed on the side of the palpating finger and instrumented syringe.
measure: Age
time frame: Day 0
description: to evaluate the Influence of age regarding the puncture forces
measure: Sex
time frame: Day 0
description: to evaluate the Influence of sex regarding the puncture forces
measure: Weight
time frame: Day 0
description: to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
measure: Height
time frame: Day 0
description: to measure body mass index BMI and evaluate the its Influence of regarding the puncture forces
arm group label: Young males of normal corpulence
arm group type: Experimental
description: Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25
arm group label: Young females of normal corpulence
arm group type: Experimental
description: Insertion of a catheter to people ageg between 18 and 25; IBM between 18,5 and 25
arm group label: Aged males of normal corpulence
arm group type: Experimental
description: Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25
arm group label: Aged females of normal corpulence
arm group type: Experimental
description: Insertion of a catheter to people ageg between 60 and 75; IBM between 18,5 and 25
arm group label: Obese young males
arm group type: Experimental
description: Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30
arm group label: Obese young females
arm group type: Experimental
description: Insertion of a catheter to people ageg between 18 and 25; superior or equal to 30
arm group label: Obese aged males
arm group type: Experimental
description: Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30
arm group label: Obese aged females
arm group type: Experimental
description: Insertion of a catheter to people ageg between 60 and 75; IBM superior or equal to 30
intervention type: Procedure
intervention name: insertion of a catheter
description: Analysis the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins
arm group label: Aged females of normal corpulence
arm group label: Aged males of normal corpulence
arm group label: Obese aged females
arm group label: Obese aged males
arm group label: Obese young females
arm group label: Obese young males
arm group label: Young females of normal corpulence
arm group label: Young males of normal corpulence
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anthony Viste
phone: 4 78 86 37 38
phone ext: +33
email: anthony.viste@univ-lyon1.fr
last name: Kevin Torossian
email: kevin.torossian@ifsttar.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor