<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/NCT04416009</url>
  </required_header>
  <id_info>
    <org_study_id>76</org_study_id>
    <nct_id>NCT04416009</nct_id>
  </id_info>
  <brief_title>Extracellular Water in Covid 19 Pneumonia</brief_title>
  <official_title>the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to various studies Covid 19 pneumonia has a very similar clinical course to Acute&#xD;
      Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this&#xD;
      similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in&#xD;
      covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body&#xD;
      bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the&#xD;
      clinical apperence of covid 19 pneumonia clinical course.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According&#xD;
      to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory&#xD;
      Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the&#xD;
      similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical&#xD;
      apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and&#xD;
      severty of the pneumonia.&#xD;
&#xD;
      In this prospective -controlled research, the patients who were diagnosed with Covid-19&#xD;
      pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and&#xD;
      the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in&#xD;
      addition to other heamodynamic parametres, ECW will be recorded using non-invasive body&#xD;
      biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two&#xD;
      groups.&#xD;
&#xD;
      The ward and intensive care patients will be connected to the NİCaS machine to determine ECW&#xD;
      and statistically significantchanges will be recorded. The device consists of a laptop, a&#xD;
      software which calculates cardiac parameters and two electrodes. The measurement is done by&#xD;
      the following process: one of these electrodes, which looks like ECG electrodes, is stuck to&#xD;
      the wrist and the other one to the opposite ankle or each one to two wrists.&#xD;
&#xD;
      the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E.,&#xD;
      Buchner, A., &amp; Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for&#xD;
      correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for&#xD;
      istatistical power analysis.The power analysis was done priorly and based on the T-test.In&#xD;
      order to provide enoughsample magnitude power, which is 0.8, it was calculated that each&#xD;
      group should have 26 patients which makes at total of 52 Statistical method: The normal&#xD;
      distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be&#xD;
      used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions.&#xD;
      İntergroup ECW values will be compared via independent sample T test. In catagoric data, the&#xD;
      comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be&#xD;
      considered as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 5, 2020</start_date>
  <completion_date type="Anticipated">February 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 20, 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>1 Day</target_duration>
  <primary_outcome>
    <measure>ECW</measure>
    <time_frame>three measurements with half an hour intervals</time_frame>
    <description>Changes of three measurements of extracellular water in both lungs</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Extracellular Fluid Alteration</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>mild pneumonia ECW</arm_group_label>
    <description>the covid 19 pneumonia patients who hospitalised to the ward</description>
  </arm_group>
  <arm_group>
    <arm_group_label>severe pneumonia ECW</arm_group_label>
    <description>the covid 19 pneumonia patients who hospitalised to the intensive care unit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NİCaS</intervention_name>
    <description>whole body bioimpedence method</description>
    <arm_group_label>mild pneumonia ECW</arm_group_label>
    <arm_group_label>severe pneumonia ECW</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized covid 19 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Covid 19 pneumonia, hospitalized patients older than 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        younger than 18 years old, patients not infected with covid 19&#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>Gaziosmanpaşa TREH</name>
      <address>
        <city>Istanbul</city>
        <state>Gaziosmanpaşa</state>
        <zip>34255</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zuhal çavuş, MD</last_name>
      <phone>+902129453000</phone>
      <phone_ext>1436</phone_ext>
      <email>zuhalcavus74@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>aygen türkmen, Prof.MD</last_name>
      <phone>+902129453000</phone>
      <phone_ext>1641</phone_ext>
      <email>aygenturkmen@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Tagami T, Ong MEH. Extravascular lung water measurements in acute respiratory distress syndrome: why, how, and when? Curr Opin Crit Care. 2018 Jun;24(3):209-215. doi: 10.1097/MCC.0000000000000503.</citation>
    <PMID>29608455</PMID>
  </reference>
  <reference>
    <citation>Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.</citation>
    <PMID>26546321</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gaziosmanpasa Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>SİBEL BEKTAŞ</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>NİCaS</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Coronavirus 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/NCT04416009
org study id: 76
nct id: NCT04416009
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
According to various studies Covid 19 pneumonia has a very similar clinical course to Acute
      Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this
      similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in
      covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body
      bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the
      clinical apperence of covid 19 pneumonia clinical course.
Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According
      to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory
      Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the
      similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical
      apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and
      severty of the pneumonia.

      In this prospective -controlled research, the patients who were diagnosed with Covid-19
      pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and
      the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in
      addition to other heamodynamic parametres, ECW will be recorded using non-invasive body
      biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two
      groups.

      The ward and intensive care patients will be connected to the NİCaS machine to determine ECW
      and statistically significantchanges will be recorded. The device consists of a laptop, a
      software which calculates cardiac parameters and two electrodes. The measurement is done by
      the following process: one of these electrodes, which looks like ECG electrodes, is stuck to
      the wrist and the other one to the opposite ankle or each one to two wrists.

      the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E.,
      Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for
      correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for
      istatistical power analysis.The power analysis was done priorly and based on the T-test.In
      order to provide enoughsample magnitude power, which is 0.8, it was calculated that each
      group should have 26 patients which makes at total of 52 Statistical method: The normal
      distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be
      used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions.
      İntergroup ECW values will be compared via independent sample T test. In catagoric data, the
      comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be
      considered as significant.
observational model: Cohort
time perspective: Prospective
measure: ECW
time frame: three measurements with half an hour intervals
description: Changes of three measurements of extracellular water in both lungs
arm group label: mild pneumonia ECW
description: the covid 19 pneumonia patients who hospitalised to the ward
arm group label: severe pneumonia ECW
description: the covid 19 pneumonia patients who hospitalised to the intensive care unit
intervention type: Device
intervention name: NİCaS
description: whole body bioimpedence method
arm group label: mild pneumonia ECW
arm group label: severe pneumonia ECW
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Tagami T, Ong MEH. Extravascular lung water measurements in acute respiratory distress syndrome: why, how, and when? Curr Opin Crit Care. 2018 Jun;24(3):209-215. doi: 10.1097/MCC.0000000000000503.
PMID: 29608455
citation: Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.
PMID: 26546321
responsible party type: Principal Investigator
investigator affiliation: Gaziosmanpasa Research and Education Hospital
investigator full name: SİBEL BEKTAŞ
investigator title: director
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Coronavirus Infections
sharing ipd: No