<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/NCT04409418</url>
  </required_header>
  <id_info>
    <org_study_id>2020-053</org_study_id>
    <nct_id>NCT04409418</nct_id>
  </id_info>
  <brief_title>Blood Sampling Functionality of Extended Dwell Catheters</brief_title>
  <official_title>Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter&#xD;
      (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral&#xD;
      Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using&#xD;
      ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be&#xD;
      inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be&#xD;
      left for up to 30 days and don't fail as quickly when compared to peripheral IVs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients will require ongoing blood draws for laboratory testing while in the hospital&#xD;
      and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated&#xD;
      with an increase in complications such as irritation and infiltration (where the IV&#xD;
      medication or fluid will leak out of the vein and into the surrounding tissue). Therefore,&#xD;
      patients are often required to have multiple needlesticks throughout their hospital stay&#xD;
      which can lead to patient dissatisfaction and anxiety.&#xD;
&#xD;
      Extended dwell catheters (EDC) offer an alternative to peripheral IVs especially during&#xD;
      prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are&#xD;
      commonly placed in any of 3 veins in the arm. They can be inserted above or below the&#xD;
      antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and&#xD;
      don't fail as quickly when compared to peripheral IVs. While there is not a lot of evidence&#xD;
      about how well these catheters will allow blood to be drawn, an EDC can be used to obtain&#xD;
      blood for routine blood draws and potentially eliminiate the need for additional needle&#xD;
      sticks.&#xD;
&#xD;
      Eligible patients in this study will be randomized to two groups based on placement site:&#xD;
      experimental group (forearm) or the control group (upper arm). If the patient is in the&#xD;
      control group the research staff will direct the inserter to place the catheter into the&#xD;
      upper arm vein at least 2 cm above the antecubital fossa. If the patient is randomized to the&#xD;
      experimental group (lower arm), the research staff will direct the insert to place the&#xD;
      catheter into the forearm at least 10 cm away from the antecubital fossa. The research team&#xD;
      will capture images on the ultrasound machine that is used for initial assessment of sites&#xD;
      per routine care. If the vein is appropriate for cannulation based on these assessments, the&#xD;
      Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access&#xD;
      Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may&#xD;
      evaluate another site that is more suitable for cannulation. Functionality will be confirmed&#xD;
      by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc&#xD;
      of normal saline without resistance. The site of insertion will be recorded and pertinent&#xD;
      information will be collected similar to other catheter placements. Securement of the placed&#xD;
      IV will be standardized between groups. Daily assessment of functionality (patency of the&#xD;
      catheter) will be performed by the research team for the life of the catheter while&#xD;
      hospitalized (up to 30 days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 23, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>Prospective, single-site, randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Sampling Functionality</measure>
    <time_frame>During hospitalization, up to 30 days</time_frame>
    <description>Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of days until failure to aspirate blood identified during follow-up assessment during hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catheter Dwell time/Survival</measure>
    <time_frame>During hospitalization, up to 30 days</time_frame>
    <description>Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of days until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization. Duration of dwell and functional failure of the catheter will be employed to estimate catheter survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis</measure>
    <time_frame>During hospitalization, up to 30 days</time_frame>
    <description>The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>IV Catheter-Related Infection or Complication</condition>
  <condition>Vascular Access Complication</condition>
  <condition>Peripheral Venous Access</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extended dwell catheters</intervention_name>
    <description>EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inpatient Inclusion Criteria:&#xD;
&#xD;
          1. Consult to VAT for vascular access device placement&#xD;
&#xD;
          2. Patient requires peripheral access&#xD;
&#xD;
          3. Adults &gt;18 years of age&#xD;
&#xD;
        ED Patient Inclusion Criteria&#xD;
&#xD;
          1. Age &gt; 18 years old&#xD;
&#xD;
          2. Difficult vascular access defined as: patient has no visible veins (&gt;2mm) or palpable&#xD;
             veins&#xD;
&#xD;
          3. Anticipated hospital admission&#xD;
&#xD;
        All patients meeting inclusion criteria will be pre-scanned prior to formal enrollment to&#xD;
        identify diameter of target veins and calculate a catheter to vein ratio at the potential&#xD;
        insertion site. Patients must meet this criteria in both upper arm and forearm locations&#xD;
        prior to enrollment and randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if:&#xD;
&#xD;
          1. Multiple lumens required&#xD;
&#xD;
          2. Functional vascular access device exists proximal to the targeted area of insertion.&#xD;
             This does not include superficial non-ultrasound guided peripheral IVs.&#xD;
&#xD;
          3. Upper extremity cannot be accessed due to a coexisting medical condition&#xD;
&#xD;
          4. Cognitively impaired&#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>Amit Bahl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Scribner, RN</last_name>
    <phone>248-898-5590</phone>
    <email>Lauren.Scribner@beaumont.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beaumont Hospital - Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Amit Bahl</investigator_full_name>
    <investigator_title>Director Emergency Medicine Ultrasound</investigator_title>
  </responsible_party>
  <keyword>intravenous access</keyword>
  <keyword>vascular access</keyword>
  <keyword>IV survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Catheter-Related Infections</mesh_term>
  </condition_browse>
  <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/NCT04409418
org study id: 2020-053
nct id: NCT04409418
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter
      (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral
      Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using
      ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be
      inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be
      left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Many patients will require ongoing blood draws for laboratory testing while in the hospital
      and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated
      with an increase in complications such as irritation and infiltration (where the IV
      medication or fluid will leak out of the vein and into the surrounding tissue). Therefore,
      patients are often required to have multiple needlesticks throughout their hospital stay
      which can lead to patient dissatisfaction and anxiety.

      Extended dwell catheters (EDC) offer an alternative to peripheral IVs especially during
      prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are
      commonly placed in any of 3 veins in the arm. They can be inserted above or below the
      antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and
      don't fail as quickly when compared to peripheral IVs. While there is not a lot of evidence
      about how well these catheters will allow blood to be drawn, an EDC can be used to obtain
      blood for routine blood draws and potentially eliminiate the need for additional needle
      sticks.

      Eligible patients in this study will be randomized to two groups based on placement site:
      experimental group (forearm) or the control group (upper arm). If the patient is in the
      control group the research staff will direct the inserter to place the catheter into the
      upper arm vein at least 2 cm above the antecubital fossa. If the patient is randomized to the
      experimental group (lower arm), the research staff will direct the insert to place the
      catheter into the forearm at least 10 cm away from the antecubital fossa. The research team
      will capture images on the ultrasound machine that is used for initial assessment of sites
      per routine care. If the vein is appropriate for cannulation based on these assessments, the
      Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access
      Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may
      evaluate another site that is more suitable for cannulation. Functionality will be confirmed
      by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc
      of normal saline without resistance. The site of insertion will be recorded and pertinent
      information will be collected similar to other catheter placements. Securement of the placed
      IV will be standardized between groups. Daily assessment of functionality (patency of the
      catheter) will be performed by the research team for the life of the catheter while
      hospitalized (up to 30 days).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, single-site, randomized
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Sampling Functionality
time frame: During hospitalization, up to 30 days
description: Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of days until failure to aspirate blood identified during follow-up assessment during hospitalization.
measure: Catheter Dwell time/Survival
time frame: During hospitalization, up to 30 days
description: Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of days until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization. Duration of dwell and functional failure of the catheter will be employed to estimate catheter survival.
measure: Thrombosis
time frame: During hospitalization, up to 30 days
description: The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.
arm group label: Experimental Group
arm group type: Experimental
description: If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa.
arm group label: Control Group
arm group type: Active Comparator
description: Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa.
intervention type: Device
intervention name: Extended dwell catheters
description: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
arm group label: Control Group
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amit Bahl, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
last name: Lauren Scribner, RN
phone: 248-898-5590
email: Lauren.Scribner@beaumont.org
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Amit Bahl
investigator title: Director Emergency Medicine Ultrasound
mesh term: Catheter-Related Infections
sharing ipd: No