<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/NCT02985528</url>
  </required_header>
  <id_info>
    <org_study_id>TUSMASTER</org_study_id>
    <nct_id>NCT02985528</nct_id>
  </id_info>
  <brief_title>Emergency Thoracic Ultrasound and Clinical Risk Management</brief_title>
  <acronym>CLINRISKETUS</acronym>
  <official_title>Emergency Thoracic Ultrasound and Clinical Risk Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guglielmo Trovato, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound&#xD;
      (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency&#xD;
      diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR&#xD;
      &quot;unforeseen diagnosis&quot;, provided by TUS, exploring usefulness and sustainability of&#xD;
      telementoring aimed at the management of clinical risk. This observational report includes a&#xD;
      period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis&#xD;
      using freely available smartphone applications for the transfer of images and movies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study describes a six months period of specialist activity of an Emergency&#xD;
      Department physician. The aim is to display the performance in the subsets of difficult or&#xD;
      unexpected thoracic ultrasound imaging performed by TUS, in a context with the prompt&#xD;
      availability of all radiological facilities. The interaction of TUS telementoring, using&#xD;
      WhatsApp® or Skype®, provided by another colleague, in another city and hospital, with a&#xD;
      greater specific expertise in TUS, was devised to assure a concurrent mentorship by the&#xD;
      School. This training has included a subsequent revaluation of clinical cases by the&#xD;
      Ultrasound Course Lecturer in TUS and by the Director of the School of Clinical Ultrasound,&#xD;
      with a reappraisal overview of all the available information. The approach was clinical and&#xD;
      instrumental, and included:&#xD;
&#xD;
      A. clinical history; B. clinical examination of chest, neck, joints and abdomen; C.&#xD;
      sequential ultrasound examination of the abdomen, thorax, pericardium; D. focus on pain&#xD;
      symptoms: of chest, abdomen (with or without distention), lumbar region, neck; E. focus on&#xD;
      dyspnea and/or cough and/or fever with detection of humid or dry lung sounds, chest dullness,&#xD;
      of heart and/or pleura-pericardial sounds, and/or jugular congestion, checking also the&#xD;
      mobility of the diaphragm and evaluating the collapsibility of the cava vein.&#xD;
&#xD;
      TUS was generally conducted with the patient in a sitting position, although the few patients&#xD;
      (predominantly children), likely to experience severe discomfort during the procedure, were&#xD;
      scanned in a semi-supine position. A systematic examination of all intercostal spaces was&#xD;
      performed and TUS images, if present, were assessed for the number, location, shape, size,&#xD;
      and breath-dependent changes in consolidation areas. Two main types of pattern of lung&#xD;
      consolidation attributable to pneumonia were defined: hypoechoic consolidation and mixed&#xD;
      consolidation. The presence of air bronchogram, fluid bronchogram, and basal pleural effusion&#xD;
      was also reported. The size of the consolidation area was measured longitudinally and&#xD;
      transversally, using the longest measurement, i.e., the maximal length of the consolidation&#xD;
      area visible by TUS, for data analysis. For the purpose of this report, details on the&#xD;
      measurements are not detailed.&#xD;
&#xD;
      The second opinion was provided outside the Hospital facility by a mentor (FMT), expert in&#xD;
      Clinical Ultrasound, answering to the questions related to the images of videoclips of the&#xD;
      actual patient in emergency. Images and movies were sent by WhatsApp. Reappraisal was&#xD;
      performed subsequently, using all the available imaging - photos and videoclips, the clinical&#xD;
      records and the outcome information, as obtainable by a short-term follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>level of individual diagnostic accuracy of TUS vs. CXR</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Chest Disorders</condition>
  <arm_group>
    <arm_group_label>TUS positive</arm_group_label>
    <description>Ultrasound detection of pleuro-pulmonary disease and further diagnostic and imaging when needed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CXR positive</arm_group_label>
    <description>Radiographic detection of pleuro-pulmonary disease and further diagnostic and imaging when needed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>further diagnostic</intervention_name>
    <description>further diagnostic procedures - mainly CHEST CT -</description>
    <arm_group_label>CXR positive</arm_group_label>
    <arm_group_label>TUS positive</arm_group_label>
    <other_name>chest CT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        observations of a single physician of consecutivo emergency patients, (excluding trauma&#xD;
        patients) addressed to a single facility for pain symptoms: of chest, abdomen (with or&#xD;
        without distention), lumbar region, neck; and/or dyspnea and/or cough and/or fever with&#xD;
        detection of humid or dry lung sounds, chest dullness, of heart and/or pleura-pericardial&#xD;
        sounds, and/or jugular congestion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included in this study have satisfied one of these two criteria of unexpected&#xD;
             diagnosis after TUS examination:&#xD;
&#xD;
               1. Patients in which chest radiography was not diagnostic, or totally negative, in&#xD;
                  which thoracic ultrasound suggested evidence of a specific pathology&#xD;
                  (consolidation, effusion, pneumothorax), later confirmed by CT.&#xD;
&#xD;
               2. Patients with detection of a chest disease on chest radiographs, and which a&#xD;
                  specific condition was further detailed, or differently addressed by the&#xD;
                  ultrasound procedure, and confirmed by CT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with non-invasive pulse oximetry lower than 92.0% of Peripheral oxygen&#xD;
             saturation (SpO2) , with clinical or instrumental signs of heart failure, in&#xD;
             hemodialysis or with severe renal insufficiency, with a known diagnosis of solid or&#xD;
             blood tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele</investigator_affiliation>
    <investigator_full_name>Guglielmo Trovato, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine - Research Project Planning Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT02985528
org study id: TUSMASTER
nct id: NCT02985528
lead sponsor: 
has dmc: No
Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound
      (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency
      diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR
      "unforeseen diagnosis", provided by TUS, exploring usefulness and sustainability of
      telementoring aimed at the management of clinical risk. This observational report includes a
      period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis
      using freely available smartphone applications for the transfer of images and movies.
The present study describes a six months period of specialist activity of an Emergency
      Department physician. The aim is to display the performance in the subsets of difficult or
      unexpected thoracic ultrasound imaging performed by TUS, in a context with the prompt
      availability of all radiological facilities. The interaction of TUS telementoring, using
      WhatsApp® or Skype®, provided by another colleague, in another city and hospital, with a
      greater specific expertise in TUS, was devised to assure a concurrent mentorship by the
      School. This training has included a subsequent revaluation of clinical cases by the
      Ultrasound Course Lecturer in TUS and by the Director of the School of Clinical Ultrasound,
      with a reappraisal overview of all the available information. The approach was clinical and
      instrumental, and included:

      A. clinical history; B. clinical examination of chest, neck, joints and abdomen; C.
      sequential ultrasound examination of the abdomen, thorax, pericardium; D. focus on pain
      symptoms: of chest, abdomen (with or without distention), lumbar region, neck; E. focus on
      dyspnea and/or cough and/or fever with detection of humid or dry lung sounds, chest dullness,
      of heart and/or pleura-pericardial sounds, and/or jugular congestion, checking also the
      mobility of the diaphragm and evaluating the collapsibility of the cava vein.

      TUS was generally conducted with the patient in a sitting position, although the few patients
      (predominantly children), likely to experience severe discomfort during the procedure, were
      scanned in a semi-supine position. A systematic examination of all intercostal spaces was
      performed and TUS images, if present, were assessed for the number, location, shape, size,
      and breath-dependent changes in consolidation areas. Two main types of pattern of lung
      consolidation attributable to pneumonia were defined: hypoechoic consolidation and mixed
      consolidation. The presence of air bronchogram, fluid bronchogram, and basal pleural effusion
      was also reported. The size of the consolidation area was measured longitudinally and
      transversally, using the longest measurement, i.e., the maximal length of the consolidation
      area visible by TUS, for data analysis. For the purpose of this report, details on the
      measurements are not detailed.

      The second opinion was provided outside the Hospital facility by a mentor (FMT), expert in
      Clinical Ultrasound, answering to the questions related to the images of videoclips of the
      actual patient in emergency. Images and movies were sent by WhatsApp. Reappraisal was
      performed subsequently, using all the available imaging - photos and videoclips, the clinical
      records and the outcome information, as obtainable by a short-term follow-up.
observational model: Case-Only
time perspective: Prospective
measure: level of individual diagnostic accuracy of TUS vs. CXR
time frame: one day
arm group label: TUS positive
description: Ultrasound detection of pleuro-pulmonary disease and further diagnostic and imaging when needed
arm group label: CXR positive
description: Radiographic detection of pleuro-pulmonary disease and further diagnostic and imaging when needed
intervention type: Other
intervention name: further diagnostic
description: further diagnostic procedures - mainly CHEST CT -
arm group label: CXR positive
arm group label: TUS positive
other name: chest CT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
investigator full name: Guglielmo Trovato, MD, PhD
investigator title: Professor of Medicine - Research Project Planning Unit
mesh term: Emergencies
sharing ipd: No