<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/NCT04483193</url>
  </required_header>
  <id_info>
    <org_study_id>284/36</org_study_id>
    <nct_id>NCT04483193</nct_id>
  </id_info>
  <brief_title>Reliability of Duplex Ultrasound for Diagnosis of Deep Vein Thrombosis Performed by Nurses</brief_title>
  <official_title>Reliability of Extended Duplex Ultrasound for Diagnosis of Proximal Deep Vein Thrombosis Performed by General Intensive Care Unit Nurses in the Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Service of the Central Bohemian Region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk Hospital Usti nad Labem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Service of the Central Bohemian Region, Czech Republic</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>
      The purpose of this study is to assess validity of extended duplex ultrasound examination for&#xD;
      diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in&#xD;
      the critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients hospitalized in the intensive care unit are in increased risk of&#xD;
      proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the&#xD;
      first choice is Point-of-Care ultrasound examination. This method is usually performed by a&#xD;
      trained intensive care physician. However, if this examination could be performed by trained&#xD;
      nurses, its availability would be greatly increased. The results of the investigator's pilot&#xD;
      study showed that general nurses are able to diagnose proximal deep vein thrombosis in&#xD;
      critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a&#xD;
      specificity of 99 %. Before implementation of this examination into the optional competencies&#xD;
      of general nurses, the results need to be confirmed in a larger group of patients. This is&#xD;
      the goal of proposed clinical study.&#xD;
&#xD;
      In this prospective observational study, the patients will be investigated by extended duplex&#xD;
      ultrasound (compression ultrasound test combined with colour doppler imaging in the range&#xD;
      from the groin to the popliteal region) by a trained nurse and on the same day, the&#xD;
      examination will be repeated by a trained physician - intensivist. The results of the&#xD;
      examinations of each patient will be blinded until both tests will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of duplex ultrasound</measure>
    <time_frame>Comparison of two examinations performed with a maximum interval of 24 hours.</time_frame>
    <description>Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>Critically ill patients hospitalised at the intensive care unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Duplex ultrasound</intervention_name>
    <description>Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients&#xD;
&#xD;
          -  Critically ill patients hospitalised in the intensive care unit for more than 72 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known deep vein thrombosis&#xD;
&#xD;
          -  Contraindication of ultrasound examination&#xD;
&#xD;
          -  Refusal of ultrasound examination by patient&#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>Roman Skulec, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk Hospital Usti nad Labem</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <phone>00420777577497</phone>
    <email>skulec@email.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lenka Miksova</last_name>
    <phone>00420774140032</phone>
    <email>lenusmiksova@seznam.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Masaryk Hospital Usti nad Labem</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>40113</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roman Skulec, MD, PhD</last_name>
      <phone>00420777577497</phone>
      <email>skulec@email.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.</citation>
    <PMID>32216998</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Masaryk Hospital Usti nad Labem</investigator_affiliation>
    <investigator_full_name>Roman Skulec</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT04483193
org study id: 284/36
nct id: NCT04483193
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess validity of extended duplex ultrasound examination for
      diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in
      the critically ill patients.
Critically ill patients hospitalized in the intensive care unit are in increased risk of
      proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the
      first choice is Point-of-Care ultrasound examination. This method is usually performed by a
      trained intensive care physician. However, if this examination could be performed by trained
      nurses, its availability would be greatly increased. The results of the investigator's pilot
      study showed that general nurses are able to diagnose proximal deep vein thrombosis in
      critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a
      specificity of 99 %. Before implementation of this examination into the optional competencies
      of general nurses, the results need to be confirmed in a larger group of patients. This is
      the goal of proposed clinical study.

      In this prospective observational study, the patients will be investigated by extended duplex
      ultrasound (compression ultrasound test combined with colour doppler imaging in the range
      from the groin to the popliteal region) by a trained nurse and on the same day, the
      examination will be repeated by a trained physician - intensivist. The results of the
      examinations of each patient will be blinded until both tests will be performed.
observational model: Case-Only
time perspective: Prospective
measure: Validity of duplex ultrasound
time frame: Comparison of two examinations performed with a maximum interval of 24 hours.
description: Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.
arm group label: Critically ill patients
description: Critically ill patients hospitalised at the intensive care unit.
intervention type: Diagnostic Test
intervention name: Duplex ultrasound
description: Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.
arm group label: Critically ill patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roman Skulec, MD, PhD
role: Principal Investigator
affiliation: Masaryk Hospital Usti nad Labem
last name: Roman Skulec, MD, PhD
phone: 00420777577497
email: skulec@email.cz
last name: Lenka Miksova
phone: 00420774140032
email: lenusmiksova@seznam.cz
facility: 
status: Recruiting
contact: 
country: Czechia
citation: Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.
PMID: 32216998
responsible party type: Principal Investigator
investigator affiliation: Masaryk Hospital Usti nad Labem
investigator full name: Roman Skulec
investigator title: Principal investigator
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: No