<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/NCT04412551</url>
  </required_header>
  <id_info>
    <org_study_id>LUS-Covid001</org_study_id>
    <nct_id>NCT04412551</nct_id>
  </id_info>
  <brief_title>Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19</brief_title>
  <official_title>Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalarna County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalarna County Council, Sweden</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>
      This observational study will describe lung ultrasound (LUS) findings over time in&#xD;
      hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to&#xD;
      investigate if lung ultrasound can identify and/or predict patients requiring mechanical&#xD;
      ventilation. Another aim is to describe LUS findings associated with clinical findings and&#xD;
      patient condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study patients with moderate to severe Covid-19 infection will be screened with lung&#xD;
      ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory&#xD;
      distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and&#xD;
      consolidations will be noted. In addition to LUS, clinical parameters from physical&#xD;
      examination and laboratory tests will be collected. Participants wil be followed until either&#xD;
      admission to intensive care unit (ICU) for mechanical ventilation or until clinical&#xD;
      improvement. A group of patients with mild Covid-19 infection will be recruited and screened&#xD;
      once as reference.&#xD;
&#xD;
      Apart from assessment with LUS, patients are managed according to routine care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Weeks</target_duration>
  <primary_outcome>
    <measure>Identification of requirement of mechanical ventilation</measure>
    <time_frame>3 weeks</time_frame>
    <description>Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prediction of requirement of mechanical ventilation</measure>
    <time_frame>3 weeks</time_frame>
    <description>Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of LUS to clinical parameters</measure>
    <time_frame>3 weeks</time_frame>
    <description>Descriptive assessment of clinical parameters and LUS-score over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of findings on LUS</measure>
    <time_frame>3 weeks</time_frame>
    <description>Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19</description>
  </secondary_outcome>
  <enrollment type="Actual">72</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>Virus Diseases</condition>
  <condition>Coronaviridae Infections</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to&#xD;
        stage 4-5 on the &quot;Ordinal Scale for Clinical Improvement&quot; of the World Health Organization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Covid-19 confirmed by positive polymerase chain reaction (PCR)&#xD;
&#xD;
          -  oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with&#xD;
             fraction of inspired oxygen (FiO2) ≥ 30%&#xD;
&#xD;
          -  age between 18-80 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients subject to treatment-limitation &quot;no ICU&quot;&#xD;
&#xD;
          -  history of heart failure&#xD;
&#xD;
          -  history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial&#xD;
             lung disease, pleurodesis&#xD;
&#xD;
          -  history of kidney failure requiring dialysis&#xD;
&#xD;
          -  any reason making lung ultrasound or daily follow up impossible&#xD;
&#xD;
          -  opposition to participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Falun Hospital</name>
      <address>
        <city>Falun</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for &quot;lung monitoring&quot; of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.</citation>
    <PMID>25501898</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 1, 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>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalarna County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Maria Hårdstedt</investigator_full_name>
    <investigator_title>Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>ultrasonography</keyword>
  <keyword>lung ultrasound</keyword>
  <keyword>covid-19</keyword>
  <keyword>ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Coronaviridae 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/NCT04412551
org study id: LUS-Covid001
nct id: NCT04412551
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study will describe lung ultrasound (LUS) findings over time in
      hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to
      investigate if lung ultrasound can identify and/or predict patients requiring mechanical
      ventilation. Another aim is to describe LUS findings associated with clinical findings and
      patient condition.
Study patients with moderate to severe Covid-19 infection will be screened with lung
      ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory
      distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and
      consolidations will be noted. In addition to LUS, clinical parameters from physical
      examination and laboratory tests will be collected. Participants wil be followed until either
      admission to intensive care unit (ICU) for mechanical ventilation or until clinical
      improvement. A group of patients with mild Covid-19 infection will be recruited and screened
      once as reference.

      Apart from assessment with LUS, patients are managed according to routine care.
observational model: Cohort
time perspective: Prospective
measure: Identification of requirement of mechanical ventilation
time frame: 3 weeks
description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
measure: Prediction of requirement of mechanical ventilation
time frame: 3 weeks
description: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
measure: Association of LUS to clinical parameters
time frame: 3 weeks
description: Descriptive assessment of clinical parameters and LUS-score over time
measure: Description of findings on LUS
time frame: 3 weeks
description: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Sweden
citation: Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.
PMID: 25501898
responsible party type: Principal Investigator
investigator affiliation: Dalarna County Council, Sweden
investigator full name: Maria Hårdstedt
investigator title: Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Virus Diseases
mesh term: Coronavirus Infections
mesh term: Coronaviridae Infections
sharing ipd: No