<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/NCT03290573</url>
  </required_header>
  <id_info>
    <org_study_id>FAHZU-2017-016</org_study_id>
    <nct_id>NCT03290573</nct_id>
  </id_info>
  <brief_title>Site Selection of Short Peripheral Venous Catheters</brief_title>
  <acronym>SPECIAL</acronym>
  <official_title>Site Selection of Peripheral Venous Access Via Short Peripheral Catheters in Adult Patients (SPECIAL Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Zhengzhou University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous&#xD;
      catheters for even small increments of time would further reduce the number of insertions,&#xD;
      staff workloads, and costs. In this study, the investigators investigated whether short&#xD;
      peripheral venous catheter site of insertion influence the dwell time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">January 6, 2019</completion_date>
  <primary_completion_date type="Actual">December 26, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Indwelling time</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phlebitis</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occlusion of the catheter</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infiltration</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accidental catheter removal</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local venous infection</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter-related bloodstream infection</measure>
    <time_frame>from the cannulae insertion until its removal, usually within 2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1517</enrollment>
  <condition>Short Peripheral Venous Catheter</condition>
  <arm_group>
    <arm_group_label>Dorsum of hand group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>short peripheral venous catheter place in the dorsum of the hand</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forearm group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>short peripheral venous catheter place in the forearm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>short peripheral venous catheter</intervention_name>
    <description>short peripheral venous catheter for infusion therapy in adult patients</description>
    <arm_group_label>Dorsum of hand group</arm_group_label>
    <arm_group_label>Forearm group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Expected duration of infusion therapy by short peripheral intravenous catheters &gt;7&#xD;
             days&#xD;
&#xD;
          -  Give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The peripheral venous catheter was inserted in emergency room or in emergency&#xD;
             circumstances&#xD;
&#xD;
          -  Bloodstream infection&#xD;
&#xD;
          -  Had a peripheral venous catheter already in situ at the baseline&#xD;
&#xD;
          -  Altered mental state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuanjie Wu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Zhengzhou University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Suzhou municipal hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuanwu Hospital Captial Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guizhou Provincial People's Hospital</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangtan Central Hospital</name>
      <address>
        <city>Xiangtan</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Zhengzhou University</investigator_affiliation>
    <investigator_full_name>Chuanjie Wu</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <!-- 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/NCT03290573
org study id: FAHZU-2017-016
nct id: NCT03290573
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous
      catheters for even small increments of time would further reduce the number of insertions,
      staff workloads, and costs. In this study, the investigators investigated whether short
      peripheral venous catheter site of insertion influence the dwell time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Indwelling time
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Phlebitis
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Occlusion of the catheter
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Infiltration
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Accidental catheter removal
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Local venous infection
time frame: from the cannulae insertion until its removal, usually within 2 weeks
measure: Catheter-related bloodstream infection
time frame: from the cannulae insertion until its removal, usually within 2 weeks
arm group label: Dorsum of hand group
arm group type: Active Comparator
description: short peripheral venous catheter place in the dorsum of the hand
arm group label: Forearm group
arm group type: Experimental
description: short peripheral venous catheter place in the forearm
intervention type: Device
intervention name: short peripheral venous catheter
description: short peripheral venous catheter for infusion therapy in adult patients
arm group label: Dorsum of hand group
arm group label: Forearm group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chuanjie Wu, MD
role: Study Chair
affiliation: The First Affiliated Hospital of Zhengzhou University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Zhengzhou University
investigator full name: Chuanjie Wu
investigator title: MD, PhD