<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/NCT02213965</url>
  </required_header>
  <id_info>
    <org_study_id>HC-O-H 1411</org_study_id>
    <nct_id>NCT02213965</nct_id>
  </id_info>
  <brief_title>Study Comparing the Handling of Two Peripheral IV Catheter Systems</brief_title>
  <official_title>Clinical Investigation Acc. to MPG §23b: Open-label Prospective Study Comparing the Handling of the Handling of Two Peripheral IV Catheter (PIV) Systems (Ported and Non Ported) in Randomized Order</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A peripheral intravenous catheter is the most commonly used vascular access device in&#xD;
      medicine. Primary objective is to compare insertion and handling of two peripheral&#xD;
      intravenous catheters in clinical routine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of successful puncturing on the first attempt</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of insertion failures</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate and number of testing of ease of moving</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate and number of recannulation</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate, number and kind/extend of blood emission</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of needle stick injuries</measure>
    <time_frame>During catheter fixation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Condition of fixation after completion of catheter insertion</measure>
    <time_frame>During catheter fixation until directly after catheter insertion</time_frame>
    <description>dry and clean, moisturized, soiled?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adherence to standard application requirements of catheter placement</measure>
    <time_frame>During catheter fixation until directly after catheter fixation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For Vasofix Safety: Rate and nature of use of application port</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General judgment of catheter (school class grading)</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Age and gender of the patient</measure>
    <time_frame>At the beginning of the investigation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ASA score of the patient</measure>
    <time_frame>At the beginning of the investigation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Weight and height of the patient</measure>
    <time_frame>At the beginning of the investigation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vein and skin condition of the patient</measure>
    <time_frame>At the beginning of the investigation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Location of Peripheral Intervenous Catheter</measure>
    <time_frame>After catheter fixation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Judgment on application port and wings given by user</measure>
    <time_frame>From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Working experience of the user</measure>
    <time_frame>At the beginning of the investigation</time_frame>
    <description>Working experience of the user in a hospital in at the beginning of the investigation</description>
  </other_outcome>
  <other_outcome>
    <measure>Function of the user</measure>
    <time_frame>At the beginning of the investigation</time_frame>
    <description>Job title of the user</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2340</enrollment>
  <condition>Intravenous Access According to Instructions For Use</condition>
  <arm_group>
    <arm_group_label>Vasofix® Safety</arm_group_label>
    <description>Peripheral IV catheter Vasofix® Safety</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Introcan Safety®</arm_group_label>
    <description>Peripheral IV catheter Introcan Safety® IV catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Peripheral IV catheter</intervention_name>
    <description>Intravenous access according to Instructions For Use</description>
    <arm_group_label>Introcan Safety®</arm_group_label>
    <arm_group_label>Vasofix® Safety</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults and children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Patients of the center Anesthesiology, Operating-Room Management and Intensive Care&#xD;
             Medicine, Gynaecology and Paediatrics in need for peripheral intravenous access&#xD;
&#xD;
          -  Male and female patients, adult and paediatric&#xD;
&#xD;
          -  Is able to give written informed consent, for children the legal representatives&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Participation in another intervention trial during the study&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  The potential insertion site shows deformities, phlebitis, infiltration, dermatitis,&#xD;
             burns, lesions, nerve injuries with paresthesia or tattoos&#xD;
&#xD;
          -  Study PIV catheter site will be placed below an old infusion site&#xD;
&#xD;
          -  Patient has a documented or known allergy sensitivity to a medical adhesive product&#xD;
             such as transparent film, adhesive dressing, tapes or liquid skin protectants&#xD;
&#xD;
          -  Patient requires the application of a topical ointment, or solution under the dressing&#xD;
             in addition to the prep required in the protocol&#xD;
&#xD;
          -  Patient has or had previous IV catheter-related phlebitis or infiltration during this&#xD;
             hospitalization&#xD;
&#xD;
          -  Patients with fear of injection&#xD;
&#xD;
          -  Preterm infants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Spies, Univ.- Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intravenous Catheter</keyword>
  <keyword>Vasofix safety</keyword>
  <keyword>Introcan safety</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/NCT02213965
org study id: HC-O-H 1411
nct id: NCT02213965
lead sponsor: 
has dmc: No
A peripheral intravenous catheter is the most commonly used vascular access device in
      medicine. Primary objective is to compare insertion and handling of two peripheral
      intravenous catheters in clinical routine.
observational model: Cohort
time perspective: Prospective
measure: Incidence of successful puncturing on the first attempt
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate of insertion failures
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate and number of testing of ease of moving
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate and number of recannulation
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate, number and kind/extend of blood emission
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Incidence of needle stick injuries
time frame: During catheter fixation
measure: Condition of fixation after completion of catheter insertion
time frame: During catheter fixation until directly after catheter insertion
description: dry and clean, moisturized, soiled?
measure: Rate of adherence to standard application requirements of catheter placement
time frame: During catheter fixation until directly after catheter fixation
measure: For Vasofix Safety: Rate and nature of use of application port
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: General judgment of catheter (school class grading)
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Adverse Events
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Age and gender of the patient
time frame: At the beginning of the investigation
measure: ASA score of the patient
time frame: At the beginning of the investigation
measure: Weight and height of the patient
time frame: At the beginning of the investigation
measure: Vein and skin condition of the patient
time frame: At the beginning of the investigation
measure: Location of Peripheral Intervenous Catheter
time frame: After catheter fixation
measure: Judgment on application port and wings given by user
time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Working experience of the user
time frame: At the beginning of the investigation
description: Working experience of the user in a hospital in at the beginning of the investigation
measure: Function of the user
time frame: At the beginning of the investigation
description: Job title of the user
arm group label: Vasofix® Safety
description: Peripheral IV catheter Vasofix® Safety
arm group label: Introcan Safety®
description: Peripheral IV catheter Introcan Safety® IV catheter
intervention type: Device
intervention name: Peripheral IV catheter
description: Intravenous access according to Instructions For Use
arm group label: Introcan Safety®
arm group label: Vasofix® Safety
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claudia Spies, Univ.- Prof. Dr.
role: Principal Investigator
affiliation: Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
facility: 
facility: 
country: Germany
responsible party type: Sponsor