<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/NCT04424277</url>
  </required_header>
  <id_info>
    <org_study_id>ZADSPECTRA</org_study_id>
    <nct_id>NCT04424277</nct_id>
  </id_info>
  <brief_title>Deformation of the Diaphragm Zone of Apposition</brief_title>
  <acronym>ZADSPECTRA</acronym>
  <official_title>Deformation of the Diaphragm Zone of Apposition During the Loading of the Respiratory System in the Healthy Volunteer. Evaluation of a New Index Measured by Speckle Tracking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Saint Joseph Saint Luc de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Saint Joseph Saint Luc de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The assessment of the work of the respiratory muscles is a fundamental clinical data in&#xD;
      intensive care, especially to guide the management of patients requiring ventilatory support.&#xD;
      This data is difficult to access in current practice. The reference technique to estimate the&#xD;
      work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and&#xD;
      evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The&#xD;
      ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the&#xD;
      deformation of the respiratory muscles during the respiratory cycle.&#xD;
&#xD;
      The investigators hypothesize that the analysis of the multidimensional deformation of the&#xD;
      diaphragm at the level of the apposition zone can produce a robust and reproducible index,&#xD;
      which is correlated with the work of breathing. The performance of this index will be&#xD;
      compared to that of the thickening fraction of the diaphragm. On the other hand, the&#xD;
      investigators will evaluate the feasibility of measuring the thickening of the accessory&#xD;
      respiratory muscles (scalene and intercostal).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifteen healthy subjects will be equipped with a double-balloon esophagogastric tube and&#xD;
      subjected to increasing and gradual loading of the respiratory system by a negative-pressure&#xD;
      inspiration device. The respiratory work will be recorded continuously by measuring the&#xD;
      transdiaphragmatic pressure (reference technique).&#xD;
&#xD;
      The recording of the deformation of the diaphragmatic apposition zone by speckle tracking&#xD;
      technique will make it possible to define a multi-dimensional deformation index of this&#xD;
      muscular portion.&#xD;
&#xD;
      The reproducibility and the repeatability of this index will be evaluated then this index&#xD;
      will be compared to the reference technique, as well as to the fraction of thickening. The&#xD;
      deformation of the accessory muscles will also be evaluated in a second step.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Coefficient of reproducibility</measure>
    <time_frame>1 hour</time_frame>
    <description>reproducibility and repetability measurments of strain (ε) and strain rate (ε') .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>agreement between the strain and pressure time product of diaphragm (PTPdi)</measure>
    <time_frame>1 hour</time_frame>
    <description>Correlation between the strain and pressure time product of diaphragm (PTPdi)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>agreement between the strain rate of the PTPdi</measure>
    <time_frame>1 hour</time_frame>
    <description>Correlation between the strain rate of the PTPdi</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').</measure>
    <time_frame>1 hour</time_frame>
    <description>Comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeatability and reproducibility of the measurement of the deformation (ε) and the rate of deformation (ε ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.</measure>
    <time_frame>1 hour</time_frame>
    <description>Repeatability and reproducibility of the measurement of the deformation (ε) and the rate of deformation (ε ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploration of the link between the deformation of the accessory respiratory muscles by speckle tracking and the PTPdi</measure>
    <time_frame>1 hour</time_frame>
    <description>Coorelatin between strain of the accessory respiratory muscles and the PTPdi</description>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Respiratory Physiology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diaphragm ultrasound</intervention_name>
    <description>respiratory loading</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects and participants will be contacted individually by the investigators. The&#xD;
        principles of the study will be explained and explained to the volunteer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteer (male or female)&#xD;
&#xD;
          -  Free and informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known pregnancy, parturient or nursing mother&#xD;
&#xD;
          -  Under 18 years old&#xD;
&#xD;
          -  Age&gt; 45 years&#xD;
&#xD;
          -  Incapable major&#xD;
&#xD;
          -  Non-affiliation to the social security system&#xD;
&#xD;
          -  Any history of respiratory pathology&#xD;
&#xD;
          -  Any history of coagulation disorder or platelet function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe CARMAS</name>
      <address>
        <city>Créteil</city>
        <state>Val De Marne</state>
        <zip>94440</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 22, 2019</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diaphragm</keyword>
  <keyword>ultrasound</keyword>
  <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/NCT04424277
org study id: ZADSPECTRA
nct id: NCT04424277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The assessment of the work of the respiratory muscles is a fundamental clinical data in
      intensive care, especially to guide the management of patients requiring ventilatory support.
      This data is difficult to access in current practice. The reference technique to estimate the
      work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and
      evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The
      ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the
      deformation of the respiratory muscles during the respiratory cycle.

      The investigators hypothesize that the analysis of the multidimensional deformation of the
      diaphragm at the level of the apposition zone can produce a robust and reproducible index,
      which is correlated with the work of breathing. The performance of this index will be
      compared to that of the thickening fraction of the diaphragm. On the other hand, the
      investigators will evaluate the feasibility of measuring the thickening of the accessory
      respiratory muscles (scalene and intercostal).
Fifteen healthy subjects will be equipped with a double-balloon esophagogastric tube and
      subjected to increasing and gradual loading of the respiratory system by a negative-pressure
      inspiration device. The respiratory work will be recorded continuously by measuring the
      transdiaphragmatic pressure (reference technique).

      The recording of the deformation of the diaphragmatic apposition zone by speckle tracking
      technique will make it possible to define a multi-dimensional deformation index of this
      muscular portion.

      The reproducibility and the repeatability of this index will be evaluated then this index
      will be compared to the reference technique, as well as to the fraction of thickening. The
      deformation of the accessory muscles will also be evaluated in a second step.
observational model: Case-Only
time perspective: Other
measure: Coefficient of reproducibility
time frame: 1 hour
description: reproducibility and repetability measurments of strain (ε) and strain rate (ε') .
measure: agreement between the strain and pressure time product of diaphragm (PTPdi)
time frame: 1 hour
description: Correlation between the strain and pressure time product of diaphragm (PTPdi)
measure: agreement between the strain rate of the PTPdi
time frame: 1 hour
description: Correlation between the strain rate of the PTPdi
measure: comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').
time frame: 1 hour
description: Comparison of repeatability and reproducibility of the various ultrasound indices (TEE, TFdi, ε and ε ').
measure: Repeatability and reproducibility of the measurement of the deformation (ε) and the rate of deformation (ε ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.
time frame: 1 hour
description: Repeatability and reproducibility of the measurement of the deformation (ε) and the rate of deformation (ε ') of the accessory muscles (scalene then intercostal) subjected to variable inspiratory loads.
measure: Exploration of the link between the deformation of the accessory respiratory muscles by speckle tracking and the PTPdi
time frame: 1 hour
description: Coorelatin between strain of the accessory respiratory muscles and the PTPdi
intervention type: Other
intervention name: diaphragm ultrasound
description: respiratory loading
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No