<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/NCT02221024</url>
  </required_header>
  <id_info>
    <org_study_id>RC 10/11</org_study_id>
    <nct_id>NCT02221024</nct_id>
  </id_info>
  <brief_title>Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency</brief_title>
  <official_title>Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children admitted in a ward often require a peripheral intravenous catheter to provide access&#xD;
      for administration of medications, nutrients, fluids, blood products. Vascular access in&#xD;
      children is a frequent and stressful procedure that should be performed as infrequently as&#xD;
      possible in order to reduce the child's pain experience and the child's and family's level of&#xD;
      distress. The maintenance of patency of indwelling catheters is therefore relevant to&#xD;
      minimize need for replacement and children discomfort.&#xD;
&#xD;
      Recent studies investigated the most effective and safe method of maintaining peripheral&#xD;
      intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the&#xD;
      use of heparin versus saline flushes, showing similar efficacy of the two approaches.&#xD;
&#xD;
      To the best of the investigators knowledge no study addressed the issue of the optimal&#xD;
      flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of&#xD;
      normal saline flushes, at 12 and 24 hours intervals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with peripheral intravenous catheter patency</measure>
    <time_frame>Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours</time_frame>
    <description>Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with blood extravasation</measure>
    <time_frame>Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours</time_frame>
    <description>Presence of blood extravasation in the site of catheter insertion, defined as the presence of changes in the site's appearence and temperature (i.e. edema, blanching, coolness) at the time of nurse's evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with pain</measure>
    <time_frame>Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours</time_frame>
    <description>Any pain at the site of catheter insertion referred by patients to nurses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with skin redness</measure>
    <time_frame>Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours</time_frame>
    <description>Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with swelling</measure>
    <time_frame>Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours</time_frame>
    <description>Presence of swelling in the site of catheter insertion at the time of nurse's evaluation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Flushing every 24 hours</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flushing with positive pressure with normal saline every 24 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flushing every 12 hours</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flushing with positive pressure with normal saline every 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flushing with positive pressure</intervention_name>
    <description>Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)</description>
    <arm_group_label>Flushing every 12 hours</arm_group_label>
    <arm_group_label>Flushing every 24 hours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <arm_group_label>Flushing every 12 hours</arm_group_label>
    <arm_group_label>Flushing every 24 hours</arm_group_label>
    <other_name>Isotonic saline solution</other_name>
    <other_name>Physiological saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroClave ICU Medica</intervention_name>
    <arm_group_label>Flushing every 12 hours</arm_group_label>
    <arm_group_label>Flushing every 24 hours</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 1 and 17 years&#xD;
&#xD;
          -  peripheral intravenous catheter 22 G or 24 G&#xD;
&#xD;
          -  need to maintain the access for at least 24 hours without infusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  need for continuous infusion therapy&#xD;
&#xD;
          -  programmed therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egidio Barbi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS Burlo Garofolo, Trieste, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silvana Schreiber, RN</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Burlo Garofolo, Trieste, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Department, IRCCS Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <state>Friuli Venezia Giulia</state>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Burlo Garofolo</investigator_affiliation>
    <investigator_full_name>Ronfani Luca</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Peripheral intravenous catheter</keyword>
  <keyword>Peripheral intravenous lock</keyword>
  <keyword>Normal saline</keyword>
  <keyword>Patency</keyword>
  <keyword>Management</keyword>
  <keyword>of peripheral</keyword>
  <keyword>intravenous catheter</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_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/NCT02221024
org study id: RC 10/11
nct id: NCT02221024
lead sponsor: 
has dmc: No
Children admitted in a ward often require a peripheral intravenous catheter to provide access
      for administration of medications, nutrients, fluids, blood products. Vascular access in
      children is a frequent and stressful procedure that should be performed as infrequently as
      possible in order to reduce the child's pain experience and the child's and family's level of
      distress. The maintenance of patency of indwelling catheters is therefore relevant to
      minimize need for replacement and children discomfort.

      Recent studies investigated the most effective and safe method of maintaining peripheral
      intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the
      use of heparin versus saline flushes, showing similar efficacy of the two approaches.

      To the best of the investigators knowledge no study addressed the issue of the optimal
      flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of
      normal saline flushes, at 12 and 24 hours intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants with peripheral intravenous catheter patency
time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
description: Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema
measure: Number of participants with blood extravasation
time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
description: Presence of blood extravasation in the site of catheter insertion, defined as the presence of changes in the site's appearence and temperature (i.e. edema, blanching, coolness) at the time of nurse's evaluation
measure: Number of participants with pain
time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
description: Any pain at the site of catheter insertion referred by patients to nurses
measure: Number of participants with skin redness
time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
description: Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation
measure: Number of participants with swelling
time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
description: Presence of swelling in the site of catheter insertion at the time of nurse's evaluation
arm group label: Flushing every 24 hours
arm group type: Experimental
description: Flushing with positive pressure with normal saline every 24 hours
arm group label: Flushing every 12 hours
arm group type: Active Comparator
description: Flushing with positive pressure with normal saline every 12 hours
intervention type: Procedure
intervention name: Flushing with positive pressure
description: Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)
arm group label: Flushing every 12 hours
arm group label: Flushing every 24 hours
intervention type: Drug
intervention name: Normal saline
arm group label: Flushing every 12 hours
arm group label: Flushing every 24 hours
other name: Isotonic saline solution
other name: Physiological saline solution
intervention type: Device
intervention name: MicroClave ICU Medica
arm group label: Flushing every 12 hours
arm group label: Flushing every 24 hours
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Egidio Barbi, MD
role: Study Chair
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
last name: Silvana Schreiber, RN
role: Study Director
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Burlo Garofolo
investigator full name: Ronfani Luca
investigator title: MD, PhD
mesh term: Pharmaceutical Solutions