<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/NCT03282331</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-345</org_study_id>
    <secondary_id>2012-A00778-35</secondary_id>
    <nct_id>NCT03282331</nct_id>
  </id_info>
  <brief_title>Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)</brief_title>
  <acronym>MORPHEIT</acronym>
  <official_title>Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)</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>
  <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>
      Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the&#xD;
      intubation of hypoxemic patients.&#xD;
&#xD;
      Electrical impedance tomographic evaluation of lung morphology variations according to the&#xD;
      preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen&#xD;
      Therapy, and NonInvasive Ventilation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit&#xD;
      complications, ranging from desaturation, severe hypoxemia and bradycardia with potential&#xD;
      cardiac arrest and death. International recommendations suggest the use of non-invasive&#xD;
      ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently&#xD;
      gained growing interest in the ICU as a treatment of acute respiratory failure, to improve&#xD;
      extubation success and as a preoxygenation device before endotracheal intubation. Conflicting&#xD;
      results have been published.&#xD;
&#xD;
      The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with&#xD;
      valve bag mask for the preoxygenation before endotracheal intubation.&#xD;
&#xD;
      Investigator propose to add a lung morphology analysis during preoxygenation. Electrical&#xD;
      impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via&#xD;
      the evolution of local thoracic impedances with electrical loop circulating around a thoracic&#xD;
      belt with electrodes.&#xD;
&#xD;
      The hypothesis is that the technique of preoxygenation might correlate with oxygen&#xD;
      desaturation and potential intubation related complications (PREONIV study). Moreover lung&#xD;
      morphology modifications evaluated by EIT might be associated with the preoxygenation&#xD;
      technique (MORPHEIT study).&#xD;
&#xD;
      Investigator wish to asses lung morphological modifications evaluated by EIT during&#xD;
      preoxygenation in a prospective non blinded randomized fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2016</start_date>
  <completion_date type="Anticipated">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking_description>open</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>electrical impedance tomography related indexes</measure>
    <time_frame>at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung inhomogeneity index</measure>
    <time_frame>at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End expiratory lung impedance</measure>
    <time_frame>at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center of Ventilation</measure>
    <time_frame>at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tidal Volume</measure>
    <time_frame>at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse oxymetry value</measure>
    <time_frame>at day 1 (at 5 minutes and at 30 minutes after intubation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of arterial oxygen (PaO2)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regurgitation rate</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxyhemoglobin desaturation below 80 %</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Adult Patients</condition>
  <condition>Requiring Intubation</condition>
  <condition>Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)</condition>
  <condition>Patient Covered by French Health Care System</condition>
  <arm_group>
    <arm_group_label>standard oxygenation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow nasal oxygen therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NonInvasive Ventilation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard oxygenation</intervention_name>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
    <arm_group_label>standard oxygenation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High flow nasal oxygenation</intervention_name>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
    <arm_group_label>High flow nasal oxygen therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>noninvasive ventilation</intervention_name>
    <description>Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation</description>
    <arm_group_label>NonInvasive Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • adults patients&#xD;
&#xD;
               -  requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)&#xD;
&#xD;
               -  patient covered by french health care system&#xD;
&#xD;
               -  patient included in Hopital Estaing, Clermont-Ferrand&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • patient refusal&#xD;
&#xD;
               -  intubation for other causes (excluding hypoxemia)&#xD;
&#xD;
               -  impossibility to measure pulse oxymetry value&#xD;
&#xD;
               -  contraindication for NIV : vomiting&#xD;
&#xD;
               -  NIV intolerance&#xD;
&#xD;
               -  cardiac arrest during intubation&#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>Thomas GODET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>0473751195</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>0473751195</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preoxygenation</keyword>
  <keyword>Intubation</keyword>
  <keyword>Electrical Impedance Tomography</keyword>
  <keyword>Lung aeration</keyword>
  <keyword>Alveolar recruitment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT03282331
org study id: CHU-345
secondary id: 2012-A00778-35
nct id: NCT03282331
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the
      intubation of hypoxemic patients.

      Electrical impedance tomographic evaluation of lung morphology variations according to the
      preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen
      Therapy, and NonInvasive Ventilation
Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit
      complications, ranging from desaturation, severe hypoxemia and bradycardia with potential
      cardiac arrest and death. International recommendations suggest the use of non-invasive
      ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently
      gained growing interest in the ICU as a treatment of acute respiratory failure, to improve
      extubation success and as a preoxygenation device before endotracheal intubation. Conflicting
      results have been published.

      The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with
      valve bag mask for the preoxygenation before endotracheal intubation.

      Investigator propose to add a lung morphology analysis during preoxygenation. Electrical
      impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via
      the evolution of local thoracic impedances with electrical loop circulating around a thoracic
      belt with electrodes.

      The hypothesis is that the technique of preoxygenation might correlate with oxygen
      desaturation and potential intubation related complications (PREONIV study). Moreover lung
      morphology modifications evaluated by EIT might be associated with the preoxygenation
      technique (MORPHEIT study).

      Investigator wish to asses lung morphological modifications evaluated by EIT during
      preoxygenation in a prospective non blinded randomized fashion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking description: open
measure: evolution of lung aeration evaluated by electrical impedance tomography during the preoxygenation for intubation of hypoxemic patients and the arterial blood oxygenation
time frame: at day 1
measure: electrical impedance tomography related indexes
time frame: at day 1 (before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
measure: Lung inhomogeneity index
time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
measure: End expiratory lung impedance
time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
measure: Center of Ventilation
time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
measure: Tidal Volume
time frame: at day 1 (during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
measure: pulse oxymetry value
time frame: at day 1 (at 5 minutes and at 30 minutes after intubation)
measure: Partial pressure of arterial oxygen (PaO2)
time frame: at day 1
measure: Regurgitation rate
time frame: at day 1
measure: oxyhemoglobin desaturation below 80 %
time frame: at day 1
arm group label: standard oxygenation
arm group type: Experimental
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
arm group label: High flow nasal oxygen therapy
arm group type: Other
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
arm group label: NonInvasive Ventilation
arm group type: Other
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
intervention type: Procedure
intervention name: Standard oxygenation
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
arm group label: standard oxygenation
intervention type: Procedure
intervention name: High flow nasal oxygenation
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
arm group label: High flow nasal oxygen therapy
intervention type: Procedure
intervention name: noninvasive ventilation
description: Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
arm group label: NonInvasive Ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas GODET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 0473751195
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hypoxia