<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/NCT03277092</url>
  </required_header>
  <id_info>
    <org_study_id>RC 22/17</org_study_id>
    <nct_id>NCT03277092</nct_id>
  </id_info>
  <brief_title>Near Infrared Light in Paediatric Blood Drawing Centre</brief_title>
  <official_title>Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Burlo Garofolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Burlo Garofolo</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>
      Reaching a peripheral venous access or making a blood sample in a scared infant or toddler&#xD;
      can be challenging even for experienced nurses o pediatricians. Up to 60% of children report&#xD;
      pain and distress during venipuncture and multiple attempts can result in more difficult&#xD;
      physical and emotional conditions for subsequent insertions so that the procedure should be&#xD;
      performed with the less number of punctures as possible. In about one third of children, more&#xD;
      than one attempt is required to achieve peripheral intravenous cannulation. In the last&#xD;
      years, specific tools have been developed to enhance the success in venipuncture or&#xD;
      incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed&#xD;
      underneath the hand, that makes vessels visible by projecting the processed image in a green&#xD;
      light directly on to the puncture site. According to previous studies, NIR had shown a trend&#xD;
      in reduction of time employed for a blood sample, in children younger of 6 yr.&#xD;
&#xD;
      The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood&#xD;
      drawing center could decrease time spent to perform the procedure and improve the rate of&#xD;
      first attempt success.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">November 28, 2017</completion_date>
  <primary_completion_date type="Actual">November 28, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to perform the procedure</measure>
    <time_frame>Intraprocedural</time_frame>
    <description>In seconds, from the placement of the tourniquet until the blood flows in the needle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success at first attempt</measure>
    <time_frame>Intraprocedural</time_frame>
    <description>Percentage of success at first attempt</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Blood Drawing Procedure</condition>
  <arm_group>
    <arm_group_label>VeinViewer® group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of near infrared light to perform blood draw (VeinViewer®)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blood drawing performed traditionally</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeinViewer®</intervention_name>
    <description>Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site</description>
    <arm_group_label>VeinViewer® group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>The blood drawing is performed traditionally</description>
    <arm_group_label>Usual care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects accessing the outpatient blood-drawing service&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  application of topical anaesthetic cream&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egidio Barbi, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Burlo Garofolo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>November 29, 2017</last_update_submitted>
  <last_update_submitted_qc>November 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child, blood drawing procedure, near Infrared light</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/NCT03277092
org study id: RC 22/17
nct id: NCT03277092
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Reaching a peripheral venous access or making a blood sample in a scared infant or toddler
      can be challenging even for experienced nurses o pediatricians. Up to 60% of children report
      pain and distress during venipuncture and multiple attempts can result in more difficult
      physical and emotional conditions for subsequent insertions so that the procedure should be
      performed with the less number of punctures as possible. In about one third of children, more
      than one attempt is required to achieve peripheral intravenous cannulation. In the last
      years, specific tools have been developed to enhance the success in venipuncture or
      incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed
      underneath the hand, that makes vessels visible by projecting the processed image in a green
      light directly on to the puncture site. According to previous studies, NIR had shown a trend
      in reduction of time employed for a blood sample, in children younger of 6 yr.

      The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood
      drawing center could decrease time spent to perform the procedure and improve the rate of
      first attempt success.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to perform the procedure
time frame: Intraprocedural
description: In seconds, from the placement of the tourniquet until the blood flows in the needle
measure: Success at first attempt
time frame: Intraprocedural
description: Percentage of success at first attempt
arm group label: VeinViewer® group
arm group type: Experimental
description: Use of near infrared light to perform blood draw (VeinViewer®)
arm group label: Usual care group
arm group type: Active Comparator
description: Blood drawing performed traditionally
intervention type: Device
intervention name: VeinViewer®
description: Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site
arm group label: VeinViewer® group
intervention type: Procedure
intervention name: Usual care
description: The blood drawing is performed traditionally
arm group label: Usual care group
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Egidio Barbi, MD PhD
role: Principal Investigator
affiliation: IRCCS Burlo Garofolo
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: No