<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/NCT04412967</url>
  </required_header>
  <id_info>
    <org_study_id>SE-2020 JG DUST</org_study_id>
    <nct_id>NCT04412967</nct_id>
  </id_info>
  <brief_title>Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique</brief_title>
  <acronym>DUST</acronym>
  <official_title>A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</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>
      Overweight and obesity may be associated with difficult intravenous access leading to longer&#xD;
      procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic&#xD;
      ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.&#xD;
&#xD;
      This was a prospective, randomized, non-blinded study to compare time and placement attempts&#xD;
      for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with&#xD;
      a BMI ≥25kg/m2.&#xD;
&#xD;
      Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.&#xD;
&#xD;
      Application time was defined as the time from applying stasis to visible blood in the PVC&#xD;
      flash-chamber.&#xD;
&#xD;
      No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on&#xD;
      average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1)&#xD;
      compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported&#xD;
      no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and&#xD;
      subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).&#xD;
&#xD;
      DUST does not decrease time to functional PVC but reduces the number of PVC placement&#xD;
      attempts in patients with BMI ≥25 kg/m2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">June 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 16, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to application</measure>
    <time_frame>1 hour</time_frame>
    <description>Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cannulation attempts</measure>
    <time_frame>1 hour</time_frame>
    <description>The total number of cannulation attempts performed per patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 hour</time_frame>
    <description>The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>1 hour</time_frame>
    <description>The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>Standard Technique PVC placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard PVC placement technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DUST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dynamic ultrasound-guided short-axis needle tip navigation (DUST)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic ultrasound-guided short-axis needle tip navigation</intervention_name>
    <description>placement of peripheral venous catheters using ultrasound guided technique</description>
    <arm_group_label>DUST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard technique of placing a PVC</intervention_name>
    <description>Standard technique with palpation or Visual inspection of the pvc placement site</description>
    <arm_group_label>Standard Technique PVC placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  REETS prioritization level of &quot;Orange&quot;, &quot;Yellow&quot;, &quot;Green&quot; or &quot;Blue&quot;&#xD;
&#xD;
          -  18 years old&#xD;
&#xD;
          -  BMI ≥25 Kg/m2&#xD;
&#xD;
          -  Need of PVC according to Emergency department guidelines&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#xD;
&#xD;
          -  Life threatening patient status (REETS prioritization level of &quot;Red&quot;)&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Blood infections&#xD;
&#xD;
          -  Puncture zone skin damaged (burns, eczema, infection)&#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>Daniel Wilhelms, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Linköping</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Daniel Wilhelms</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Nurse led</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04412967/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04412967
org study id: SE-2020 JG DUST
nct id: NCT04412967
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overweight and obesity may be associated with difficult intravenous access leading to longer
      procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic
      ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.

      This was a prospective, randomized, non-blinded study to compare time and placement attempts
      for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with
      a BMI ≥25kg/m2.

      Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.

      Application time was defined as the time from applying stasis to visible blood in the PVC
      flash-chamber.

      No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on
      average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1)
      compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported
      no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and
      subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).

      DUST does not decrease time to functional PVC but reduces the number of PVC placement
      attempts in patients with BMI ≥25 kg/m2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to application
time frame: 1 hour
description: Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
measure: Number of cannulation attempts
time frame: 1 hour
description: The total number of cannulation attempts performed per patient
measure: Patient satisfaction
time frame: 1 hour
description: The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)
measure: Perceived Pain
time frame: 1 hour
description: The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)
arm group label: Standard Technique PVC placement
arm group type: Active Comparator
description: Standard PVC placement technique
arm group label: DUST
arm group type: Experimental
description: Dynamic ultrasound-guided short-axis needle tip navigation (DUST)
intervention type: Device
intervention name: Dynamic ultrasound-guided short-axis needle tip navigation
description: placement of peripheral venous catheters using ultrasound guided technique
arm group label: DUST
intervention type: Other
intervention name: Standard technique of placing a PVC
description: Standard technique with palpation or Visual inspection of the pvc placement site
arm group label: Standard Technique PVC placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Wilhelms, Phd
role: Principal Investigator
affiliation: Linkoeping University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Daniel Wilhelms
investigator title: Principal Investigator
mesh term: Overweight
mesh term: Emergencies
sharing ipd: No
provided document: 