<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/NCT02186288</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0196</org_study_id>
    <nct_id>NCT02186288</nct_id>
  </id_info>
  <brief_title>Effect of High-flow Nasal Cannula Oxygen on Lung Volumes Determined by Electrical Impedance Tomography</brief_title>
  <acronym>OXIDIA</acronym>
  <official_title>Effect of High-flow Nasal Cannula Oxygen on Lung Volumes Determined by Electrical Impedance Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by&#xD;
      electrical impedance tomography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective clinical study in ICU with patients requiring High-flow nasal cannula oxygen&#xD;
      comparing lung volumes determined by electrical impedance tomography and diaphragmatic&#xD;
      ultrasound before, during and after High-flow nasal cannula oxygen.&#xD;
&#xD;
      Duration of High-flow nasal cannula oxygen is 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>End-expiratory lung volume (EELV) determined by electrical impedance tomography before NIV non invasive ventilation</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>End-expiratory lung volume (EELV) determined by electrical impedance tomography during NIV non invasive ventilation</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>End-expiratory lung volume (EELV) determined by electrical impedance tomography after NIV non invasive ventilation</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anterior, medio-anterior, medio-posterior and posterior EELV at each time</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diaphragmatic excursion and thickness determined by ultrasound</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilatory frequency</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Critical Care</condition>
  <condition>High-flow Nasal Cannula Oxygen</condition>
  <condition>Electrical Impedance Tomography</condition>
  <condition>End Expiratory Lung Volume</condition>
  <condition>End Expiratory Lung Impedance</condition>
  <condition>Diaphragmatic Ultrasound</condition>
  <arm_group>
    <arm_group_label>Adult ICU patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-flow nasal cannula oxygen</intervention_name>
    <arm_group_label>Adult ICU patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult ICU patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Adult ICU patients requiring High-flow nasal cannula oxygen&#xD;
&#xD;
               -  Consent of patients or family&#xD;
&#xD;
               -  Arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Tracheotomized patients&#xD;
&#xD;
               -  Dressings in the thoracic area&#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>Sébastien PERBET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 23, 2015</last_update_submitted>
  <last_update_submitted_qc>July 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Care</keyword>
  <keyword>High-flow nasal cannula oxygen</keyword>
  <keyword>Electrical impedance tomography</keyword>
  <keyword>End expiratory lung volume</keyword>
  <keyword>End expiratory lung impedance</keyword>
  <keyword>Diaphragmatic ultrasound</keyword>
  <!-- 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/NCT02186288
org study id: CHU-0196
nct id: NCT02186288
lead sponsor: 
Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by
      electrical impedance tomography
Prospective clinical study in ICU with patients requiring High-flow nasal cannula oxygen
      comparing lung volumes determined by electrical impedance tomography and diaphragmatic
      ultrasound before, during and after High-flow nasal cannula oxygen.

      Duration of High-flow nasal cannula oxygen is 30 minutes.
time perspective: Cross-Sectional
measure: End-expiratory lung volume (EELV) determined by electrical impedance tomography before NIV non invasive ventilation
time frame: at day 1
measure: End-expiratory lung volume (EELV) determined by electrical impedance tomography during NIV non invasive ventilation
time frame: at day 1
measure: End-expiratory lung volume (EELV) determined by electrical impedance tomography after NIV non invasive ventilation
time frame: at day 1
measure: Anterior, medio-anterior, medio-posterior and posterior EELV at each time
time frame: at day 1
measure: Diaphragmatic excursion and thickness determined by ultrasound
time frame: at day 1
measure: Ventilatory frequency
time frame: at day 1
arm group label: Adult ICU patients
intervention type: Other
intervention name: High-flow nasal cannula oxygen
arm group label: Adult ICU patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien PERBET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor