<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/NCT04406493</url>
  </required_header>
  <id_info>
    <org_study_id>0059-20-HYMC</org_study_id>
    <nct_id>NCT04406493</nct_id>
  </id_info>
  <brief_title>Monitoring COVID-19 Patients' Lung Fluid Using Impedance Technique</brief_title>
  <official_title>Monitoring of Lung Fluid Status of Hospitalized COVID-19 Patients by Lung Impedance Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the&#xD;
      lungs and cause water accumulation in lungs alveolus (ARDS).&#xD;
&#xD;
      Today, a chest X-ray is the only practical way to check the degree of lung accumulation.&#xD;
      However, X-Ray has many limitations and disadvantages.&#xD;
&#xD;
      Lung impedance technology allows simple lung fluid monitoring, and found to be effective in&#xD;
      HF patients who suffer from a similar problem.&#xD;
&#xD;
      The study's aim is to establish a correlation between lung fluid assessed by impedance&#xD;
      technique and x-ray examinations. To find a correlation between lung fluid assessment by&#xD;
      impedance and clinical parameters of COVID 19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the&#xD;
      lungs and cause water accumulation in lungs alveolus (ARDS). Water accumulation in pulmonary&#xD;
      alveoli leads to fast deterioration and, eventually death. It is important to note that at an&#xD;
      early stage of the disease, when the patient feels relatively good, fluid progressively&#xD;
      accumulates into the lung.&#xD;
&#xD;
      Today chest X-ray is the only practical way to check the degree of lung accumulation. Chest X&#xD;
      ray is a cumbersome method and has a rotational burden. One of the disadvantages of the x-ray&#xD;
      is that interpretation of x-ray results are operator dependent. Another disadvantage is the&#xD;
      daily monitoring of lung fluids, which is expensive.&#xD;
&#xD;
      Lung impedance technology allows simple lung fluid monitoring, and found to be effective in&#xD;
      HF patients who suffers from the same problem, fluid accumulation in lungs. Lung fluid&#xD;
      monitoring using lung impedance device may assist physicians to reveal fluid accumulation in&#xD;
      lungs, and give better understanding of the severity of the situation. Moreover, better&#xD;
      impedance values indicate improvement in patient's condition and also effectiveness of the&#xD;
      treatment.&#xD;
&#xD;
      The aim of the study is to prove the correlation between lung fluid assessed by impedance&#xD;
      technique and x-ray examinations. To find correlation between lung fluid assessment by&#xD;
      impedance and clinical parameters of COVID 19 patients.&#xD;
&#xD;
      In a case that this correlation would be found high, then it will be possible to establish&#xD;
      monitoring of lung fluid status of COVID 19 patients using lung impedance device, as a simple&#xD;
      and reliable way to determine degree of patient's deterioration as it was proved for HF&#xD;
      patients.&#xD;
&#xD;
      The main question, is if a changes in lung fluid status assessed by impedance technique may&#xD;
      indicate the need in artificial respiration before there is a drastic Deterioration in&#xD;
      patient's condition.&#xD;
&#xD;
      COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using&#xD;
      lung impedance device. The first value that has been measured will be set as BASAL.&#xD;
&#xD;
      During hospitalization, each patient will undergo this examination twice a day until&#xD;
      discharged.&#xD;
&#xD;
      Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE&#xD;
      PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a&#xD;
      factor that predicts mechanical ventilation.&#xD;
&#xD;
      The time between lung impedance started to decrease (expression of the lung fluids&#xD;
      accumulation), and the need in mechanical ventilation will be measured.&#xD;
&#xD;
      In a case that lung impedance would be found as a useful predictor of clinical condition in&#xD;
      COVID 19 patients, the application for second stage of the study will be submitted to&#xD;
      Helsinki Committee.&#xD;
&#xD;
      On the second stage of the study is planning to use lung impedance values as guide for the&#xD;
      decision about beginning mechanical ventilation of COVID 19 patients before critical&#xD;
      deterioration.&#xD;
&#xD;
      Each patient which is hospitalized in Infectious Diseases Unit of Hillel Yaffe Medical Center&#xD;
      suitable for study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Anticipated">April 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using lung impedance device. The first value that has been measured will be set as BASAL.&#xD;
During the hospitalization each patient will undergo this examination twice a day until discharged.&#xD;
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need in mechanical ventilation will be measured.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between impudence deterioration to clinical conditions and hospitalization period</measure>
    <time_frame>Estimated a month, but could be prolonged through the study completion (one year)</time_frame>
    <description>the changes in lung fluid status assessed by impedance technique will be compared to the patient's clinical conditions and the patient's length of stay.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>ARDS</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>COVID 19 patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COVID 19 patients are admitted to the Infectious Diseases Unit, will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.&#xD;
During the hospitalization each patient will undergo this examination twice a day until discharged.&#xD;
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need for mechanical ventilation will be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung impedance technique</intervention_name>
    <description>COVID 19 patients are admitted to the Infectious Diseases Unit; they will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.&#xD;
During the hospitalization, each patient will undergo this examination twice a day until discharge.&#xD;
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation.&#xD;
The time between lung impedance started to decrease (expression of the lung fluids accumulation), and the need for mechanical ventilation will be measured.</description>
    <arm_group_label>COVID 19 patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Covid-19 patient admitted to the infectious unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not agree to sign informed consent, or participating in other studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hillel Yaffe MC,</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Cleiner, M.D.</last_name>
      <phone>972-50-6246926</phone>
      <email>shochat@hy.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406493
org study id: 0059-20-HYMC
nct id: NCT04406493
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the
      lungs and cause water accumulation in lungs alveolus (ARDS).

      Today, a chest X-ray is the only practical way to check the degree of lung accumulation.
      However, X-Ray has many limitations and disadvantages.

      Lung impedance technology allows simple lung fluid monitoring, and found to be effective in
      HF patients who suffer from a similar problem.

      The study's aim is to establish a correlation between lung fluid assessed by impedance
      technique and x-ray examinations. To find a correlation between lung fluid assessment by
      impedance and clinical parameters of COVID 19 patients.
COVID 19 is a novel and severe disease. One of the problems is that the virus disturbs the
      lungs and cause water accumulation in lungs alveolus (ARDS). Water accumulation in pulmonary
      alveoli leads to fast deterioration and, eventually death. It is important to note that at an
      early stage of the disease, when the patient feels relatively good, fluid progressively
      accumulates into the lung.

      Today chest X-ray is the only practical way to check the degree of lung accumulation. Chest X
      ray is a cumbersome method and has a rotational burden. One of the disadvantages of the x-ray
      is that interpretation of x-ray results are operator dependent. Another disadvantage is the
      daily monitoring of lung fluids, which is expensive.

      Lung impedance technology allows simple lung fluid monitoring, and found to be effective in
      HF patients who suffers from the same problem, fluid accumulation in lungs. Lung fluid
      monitoring using lung impedance device may assist physicians to reveal fluid accumulation in
      lungs, and give better understanding of the severity of the situation. Moreover, better
      impedance values indicate improvement in patient's condition and also effectiveness of the
      treatment.

      The aim of the study is to prove the correlation between lung fluid assessed by impedance
      technique and x-ray examinations. To find correlation between lung fluid assessment by
      impedance and clinical parameters of COVID 19 patients.

      In a case that this correlation would be found high, then it will be possible to establish
      monitoring of lung fluid status of COVID 19 patients using lung impedance device, as a simple
      and reliable way to determine degree of patient's deterioration as it was proved for HF
      patients.

      The main question, is if a changes in lung fluid status assessed by impedance technique may
      indicate the need in artificial respiration before there is a drastic Deterioration in
      patient's condition.

      COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using
      lung impedance device. The first value that has been measured will be set as BASAL.

      During hospitalization, each patient will undergo this examination twice a day until
      discharged.

      Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE
      PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a
      factor that predicts mechanical ventilation.

      The time between lung impedance started to decrease (expression of the lung fluids
      accumulation), and the need in mechanical ventilation will be measured.

      In a case that lung impedance would be found as a useful predictor of clinical condition in
      COVID 19 patients, the application for second stage of the study will be submitted to
      Helsinki Committee.

      On the second stage of the study is planning to use lung impedance values as guide for the
      decision about beginning mechanical ventilation of COVID 19 patients before critical
      deterioration.

      Each patient which is hospitalized in Infectious Diseases Unit of Hillel Yaffe Medical Center
      suitable for study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: COVID 19 patients are admitted to Infectious Diseases Unit, will undergo examination using lung impedance device. The first value that has been measured will be set as BASAL.
During the hospitalization each patient will undergo this examination twice a day until discharged.
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need in mechanical ventilation will be measured.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between impudence deterioration to clinical conditions and hospitalization period
time frame: Estimated a month, but could be prolonged through the study completion (one year)
description: the changes in lung fluid status assessed by impedance technique will be compared to the patient's clinical conditions and the patient's length of stay.
arm group label: COVID 19 patients
arm group type: Experimental
description: COVID 19 patients are admitted to the Infectious Diseases Unit, will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.
During the hospitalization each patient will undergo this examination twice a day until discharged.
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation The time between lung impedance started to decrease (expression of the lung fluids accumulation) and the need for mechanical ventilation will be measured.
intervention type: Diagnostic Test
intervention name: Lung impedance technique
description: COVID 19 patients are admitted to the Infectious Diseases Unit; they will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.
During the hospitalization, each patient will undergo this examination twice a day until discharge.
Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation.
The time between lung impedance started to decrease (expression of the lung fluids accumulation), and the need for mechanical ventilation will be measured.
arm group label: COVID 19 patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
sharing ipd: Undecided