<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/NCT03797183</url>
  </required_header>
  <id_info>
    <org_study_id>18-1843</org_study_id>
    <nct_id>NCT03797183</nct_id>
  </id_info>
  <brief_title>Genesis Electrical Impedance Tomography (EIT): A Preliminary Study</brief_title>
  <official_title>The Associations Between EIT and Clinical Measures During Standard of Care Procedures in Patients With Respiratory Disease: A Preliminary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT)&#xD;
      imaging system for use in pediatric respiratory disease populations including neuromuscular&#xD;
      and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does&#xD;
      not use radiation, and is read through electrodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate EIT for use in pediatric respiratory disease&#xD;
      populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and&#xD;
      height matched controls.&#xD;
&#xD;
      Researchers will use EIT to determine changes in regional ventilation with pulmonary&#xD;
      interventions including airway clearance and invasive and noninvasive ventilation in a&#xD;
      pediatric respiratory disease population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 3, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.</measure>
    <time_frame>24 months</time_frame>
    <description>These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Regional conductivity changes due to ventilation</measure>
    <time_frame>24 months</time_frame>
    <description>Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia.&#xD;
This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waveform for a mesh element</measure>
    <time_frame>24 months</time_frame>
    <description>Time-series waveform indicated by time in seconds compared to Recon signal (au).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional conductivity changes due to perfusion</measure>
    <time_frame>24 months</time_frame>
    <description>This is a qualitative and quantitative aim. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional pulsatile perfusion imaging at the end of systole</measure>
    <time_frame>5 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power waveform (computed as the inner product of measured voltages and applied currents)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Premature Infant</condition>
  <condition>Chronic Respiratory Disease</condition>
  <condition>Neuromuscular Diseases</condition>
  <condition>Healthy</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <condition>Pulmonary Vein Stenoses</condition>
  <arm_group>
    <arm_group_label>Premature Infants</arm_group_label>
    <description>Premature infants &gt;1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Respiratory Disease</arm_group_label>
    <description>Participants ages &gt;1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neuromuscular Disease</arm_group_label>
    <description>Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Age and height matched healthy controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V/Q Scan validation</arm_group_label>
    <description>Adults or children who are having or have recently had a V/Q scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Premature Infants (Longitudinal Cohort)</arm_group_label>
    <description>Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary Vein/Artery Stenosis</arm_group_label>
    <description>Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        pediatric respiratory disease populations including neuromuscular and bronchopulmonary&#xD;
        dysplasia, as well as in age and height matched controls. Populations who will be&#xD;
        undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension&#xD;
        and/or pulmonary artery stenosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 weeks old - 40 years old&#xD;
&#xD;
          -  Premature infants with current age &gt;2 weeks with a confirmed diagnosis of BPD based on&#xD;
             NIH criteria&#xD;
&#xD;
          -  Or Chronic respiratory disease due to underlying neuromuscular disease&#xD;
&#xD;
          -  Or confirmed neuromuscular disease with an echo completed within the preceding 12&#xD;
             months of study participation of DMD or other diagnoses associated with mild&#xD;
             cardiomyopathy.&#xD;
&#xD;
          -  have had a VQ scan&#xD;
&#xD;
          -  will be undergoing cardiac catherization for for pulmonary vein stenosis, pulmonary&#xD;
             hypertension and/or pulmonary artery stenosis&#xD;
&#xD;
          -  Or healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;2 weeks of age&#xD;
&#xD;
          -  Congenital diaphragmatic hernia&#xD;
&#xD;
          -  Severe congenital heart disease&#xD;
&#xD;
          -  Significant genetic abnoralities&#xD;
&#xD;
          -  Anything that interferes with lead placement on the chest wall&#xD;
&#xD;
          -  Unwilling/refusal to sign consent&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Pacemaker of other surgical implant and spinal implant (causes noise in the data)&#xD;
&#xD;
          -  Moderate to severe cardiomyopathy&#xD;
&#xD;
          -  Patients with temporary cognitive disability due to illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Days</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Emily DeBoer, MD</last_name>
    <phone>720-777-4953</phone>
    <email>emily.deboer@childrenscolorado.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily DeBoer, MD</last_name>
      <phone>720-777-4953</phone>
      <email>emily.deboer@childrenscolorado.org</email>
    </contact>
    <contact_backup>
      <last_name>Allison Keck</last_name>
      <phone>720-777-0734</phone>
      <email>allison.keck@childrenscolorado.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Neuromuscular Diseases</mesh_term>
    <mesh_term>Stenosis, Pulmonary Vein</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/NCT03797183
org study id: 18-1843
nct id: NCT03797183
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT)
      imaging system for use in pediatric respiratory disease populations including neuromuscular
      and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does
      not use radiation, and is read through electrodes.
The purpose of this study is to evaluate EIT for use in pediatric respiratory disease
      populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and
      height matched controls.

      Researchers will use EIT to determine changes in regional ventilation with pulmonary
      interventions including airway clearance and invasive and noninvasive ventilation in a
      pediatric respiratory disease population.
observational model: Cohort
time perspective: Prospective
measure: EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung.
time frame: 24 months
description: These images will be analyzed both visually for qualitative abnormalities and through quantitative pixel analysis that can provide information regarding lung volume, blood volume, and changes in either based on respiratory cycle, cardiac cycle, or intervention. Areas of low ventilation (atelectasis and consolidation) will be identified.
measure: Regional conductivity changes due to ventilation
time frame: 24 months
description: Describe regional ventilation in pediatric respiratory disease populations including neuromuscular weakness, skeletal/chest wall disorders, and chronic airway and parenchymal lung disease including bronchopulmonary dysplasia.
This is a qualitative aim and will summarize EIT images pictorially. Pixel densities will be evaluated for normality and summarized as mean (SD) or median (interquartile range). EIT images will be qualitatively compared between cases and controls.
measure: Waveform for a mesh element
time frame: 24 months
description: Time-series waveform indicated by time in seconds compared to Recon signal (au).
measure: Regional conductivity changes due to perfusion
time frame: 24 months
description: This is a qualitative and quantitative aim. Results will qualitatively compare EIT images with CXR and CT scan images when available. Images will be displayed side by side and interpreted by both the clinician and the EIT study staff. Various summary measures of EIT outcomes will be calculated including pixel heterogeneity, summary changes over tidal breath and variation between tidal peaks. Pearson and Spearman correlation will be calculated between summary EIT outcomes and continuous primary clinical values. Linear and logistic regression will be used to estimate associations (with 95% CI) between EIT measures and clinical outcomes. Summary data will be presented in tables and figures using basic descriptive statistics stratified by study group.
measure: Regional pulsatile perfusion imaging at the end of systole
time frame: 5 minutes
measure: Power waveform (computed as the inner product of measured voltages and applied currents)
time frame: 24 months
arm group label: Premature Infants
description: Premature infants >1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection
arm group label: Chronic Respiratory Disease
description: Participants ages >1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease
arm group label: Neuromuscular Disease
description: Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy
arm group label: Healthy Controls
description: Age and height matched healthy controls
arm group label: V/Q Scan validation
description: Adults or children who are having or have recently had a V/Q scan
arm group label: Premature Infants (Longitudinal Cohort)
description: Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia
arm group label: Pulmonary Vein/Artery Stenosis
description: Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Days
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily DeBoer, MD
phone: 720-777-4953
email: emily.deboer@childrenscolorado.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Bronchopulmonary Dysplasia
mesh term: Neuromuscular Diseases
mesh term: Stenosis, Pulmonary Vein
sharing ipd: No