<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/NCT04432051</url>
  </required_header>
  <id_info>
    <org_study_id>Gaziosmanpasa</org_study_id>
    <nct_id>NCT04432051</nct_id>
  </id_info>
  <brief_title>The Use of Lung Ultrasonography in COVID-19 Patients</brief_title>
  <official_title>The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaziosmanpasa Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gaziosmanpasa Research and Education Hospital</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>
      In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung&#xD;
      ultrasonography will be tried to be given an appropriate position that will effectively use&#xD;
      lung capacity and its effect on oxygenation will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the COVID-19 patients hospitalized in the intensive care unit due to&#xD;
      respiratory failure will be evaluated. Participants will be divided into two groups as&#xD;
      patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung&#xD;
      ultrasonography (Group Control).&#xD;
&#xD;
      While performing lung ultrasonography, each hemithorax will be evaluated using anterior&#xD;
      axillary line and posterior axillary line into anterior, lateral and posterior region, and&#xD;
      each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be&#xD;
      scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with&#xD;
      the Lung Ultrasound Score (LUS score).&#xD;
&#xD;
      Participants in both groups will be evaluated by comparing arterial blood gas analyzes before&#xD;
      examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in&#xD;
      arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and&#xD;
      ventilation between Group Ultrasonograpy and Group Control will be evaluated?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 8, 2020</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>patients will be divided into two groups, those with and without ultrasound.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PO2 values</measure>
    <time_frame>12 hours</time_frame>
    <description>Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PCO2 values</measure>
    <time_frame>12 hours</time_frame>
    <description>Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>GRUP Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GRUP Ultrasonography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mechanical ventilator settings and position</intervention_name>
    <description>Mechanical ventilation settings and patient position will be re-evaluated</description>
    <arm_group_label>GRUP Control</arm_group_label>
    <arm_group_label>GRUP Ultrasonography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients have been diagnosed with COVID 19&#xD;
&#xD;
          -  Patients in the intensive care unit over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not diagnosed with COVID 19&#xD;
&#xD;
          -  Patients with cardiac problems&#xD;
&#xD;
          -  Patients with renal problems&#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>Gazoosmanpasa Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung ultrasonography</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>position</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04432051
org study id: Gaziosmanpasa
nct id: NCT04432051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung
      ultrasonography will be tried to be given an appropriate position that will effectively use
      lung capacity and its effect on oxygenation will be investigated.
In this study, the COVID-19 patients hospitalized in the intensive care unit due to
      respiratory failure will be evaluated. Participants will be divided into two groups as
      patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung
      ultrasonography (Group Control).

      While performing lung ultrasonography, each hemithorax will be evaluated using anterior
      axillary line and posterior axillary line into anterior, lateral and posterior region, and
      each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be
      scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with
      the Lung Ultrasound Score (LUS score).

      Participants in both groups will be evaluated by comparing arterial blood gas analyzes before
      examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in
      arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and
      ventilation between Group Ultrasonograpy and Group Control will be evaluated?
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: patients will be divided into two groups, those with and without ultrasound.
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in PO2 values
time frame: 12 hours
description: Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.
measure: Change in PCO2 values
time frame: 12 hours
description: Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.
arm group label: GRUP Control
arm group type: Placebo Comparator
description: The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.
arm group label: GRUP Ultrasonography
arm group type: Active Comparator
description: The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.
intervention type: Behavioral
intervention name: mechanical ventilator settings and position
description: Mechanical ventilation settings and patient position will be re-evaluated
arm group label: GRUP Control
arm group label: GRUP Ultrasonography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No