<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/NCT02232841</url>
  </required_header>
  <id_info>
    <org_study_id>13-4656H</org_study_id>
    <secondary_id>1R21EB016869-01A1</secondary_id>
    <nct_id>NCT02232841</nct_id>
  </id_info>
  <brief_title>Electrical Impedance Imaging of Patients on Mechanical Ventilation</brief_title>
  <official_title>Pilot Study: Electrical Impedance Imaging of Patients on Mechanical Ventilation With Lung Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance&#xD;
      Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are&#xD;
      mechanically ventilated. In electrical impedance tomography low amplitude, low frequency&#xD;
      current is applied on electrodes, and the resulting voltage is measured and used to computed&#xD;
      the electrical properties of the interior of the chest as they change in time. The computed&#xD;
      properties are used to form an image, which can then be used for monitoring and diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to characterize the ability of the electrical impedance tomography&#xD;
      system (hardware and software) to distinguish between lung pathologies by assessing the&#xD;
      sensitivity and specificity as well as the overall agreement with the CT scan in terms of&#xD;
      spatial resolution. The study will test, as well as refine, the mathematical algorithms&#xD;
      needed to create meaningful outputs on adult patients receiving mechanical ventilation and&#xD;
      who also have received or will be receiving a CT scan as part of their standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity for diagnosing lung pathology</measure>
    <time_frame>One year</time_frame>
    <description>The sensitivity and specificity of EIT for the detection and identification of different types of lung pathology will be assessed with clinical diagnosis aided by CT scan as the gold standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Regional correlation with CT scan</measure>
    <time_frame>One year</time_frame>
    <description>The spatial correlation between the organs and lung pathology in the CT scan image in the plane of the electrodes and the EIT image will be computed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Pneumothorax</condition>
  <condition>Pulmonary Contusion</condition>
  <condition>Pleural Effusion</condition>
  <condition>Pulmonary Edema</condition>
  <condition>Atelectasis</condition>
  <condition>Hyperinflation</condition>
  <condition>Emphysema</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Mechanical ventilation</arm_group_label>
    <description>Hospitalized adult patients with lung injury receiving mechanical ventilation and who also have received or will receive a CT scan as part of their standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical Ventilation</intervention_name>
    <description>Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria</description>
    <arm_group_label>Mechanical ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT Scan</intervention_name>
    <description>Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria</description>
    <arm_group_label>Mechanical ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated adult intensive care unit patients at Medical Center of the Rockies&#xD;
        with pulmonary pathology who have received or will be receiving a CT scan as part of their&#xD;
        standard care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the ICU at Medical Center of the Rockies and on mechanical&#xD;
             ventilation&#xD;
&#xD;
          -  Age greater than or equal to 18&#xD;
&#xD;
          -  Computed Tomography of the chest during normal course of hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Any skin disorder that would prevent placement of the electrodes on the chest wall&#xD;
&#xD;
          -  Hemodynamic instability prohibiting patient from being moved to place the device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer L Mueller, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.</citation>
    <PMID>23314771</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>June 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electrical impedance tomography</keyword>
  <keyword>lung imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
    <mesh_term>Pulmonary Atelectasis</mesh_term>
    <mesh_term>Pneumothorax</mesh_term>
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
    <mesh_term>Contusions</mesh_term>
  </condition_browse>
  <!-- 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/NCT02232841
org study id: 13-4656H
secondary id: 1R21EB016869-01A1
nct id: NCT02232841
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this study is to evaluate the sensitivity and specificity of Electrical Impedance
      Tomography (EIT) as a bedside diagnostic tool for lung pathologies in patients who are
      mechanically ventilated. In electrical impedance tomography low amplitude, low frequency
      current is applied on electrodes, and the resulting voltage is measured and used to computed
      the electrical properties of the interior of the chest as they change in time. The computed
      properties are used to form an image, which can then be used for monitoring and diagnosis.
The goal of this study is to characterize the ability of the electrical impedance tomography
      system (hardware and software) to distinguish between lung pathologies by assessing the
      sensitivity and specificity as well as the overall agreement with the CT scan in terms of
      spatial resolution. The study will test, as well as refine, the mathematical algorithms
      needed to create meaningful outputs on adult patients receiving mechanical ventilation and
      who also have received or will be receiving a CT scan as part of their standard of care.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Sensitivity and specificity for diagnosing lung pathology
time frame: One year
description: The sensitivity and specificity of EIT for the detection and identification of different types of lung pathology will be assessed with clinical diagnosis aided by CT scan as the gold standard.
measure: Regional correlation with CT scan
time frame: One year
description: The spatial correlation between the organs and lung pathology in the CT scan image in the plane of the electrodes and the EIT image will be computed.
arm group label: Mechanical ventilation
description: Hospitalized adult patients with lung injury receiving mechanical ventilation and who also have received or will receive a CT scan as part of their standard care
intervention type: Device
intervention name: Mechanical Ventilation
description: Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria
arm group label: Mechanical ventilation
intervention type: Device
intervention name: CT Scan
description: Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria
arm group label: Mechanical ventilation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer L Mueller, Ph.D.
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
citation: Hamilton SJ, Mueller JL. Direct EIT reconstructions of complex admittivities on a chest-shaped domain in 2-D. IEEE Trans Med Imaging. 2013 Apr;32(4):757-69. doi: 10.1109/TMI.2012.2237389. Epub 2013 Jan 9.
PMID: 23314771
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Pleural Effusion
mesh term: Pulmonary Atelectasis
mesh term: Pneumothorax
mesh term: Pulmonary Edema
mesh term: Emphysema
mesh term: Contusions