<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/NCT03295344</url>
  </required_header>
  <id_info>
    <org_study_id>BOUARD ELLOUZE 2016</org_study_id>
    <nct_id>NCT03295344</nct_id>
  </id_info>
  <brief_title>Study of Diaphragm Mobility on Tissue Doppler</brief_title>
  <acronym>DD</acronym>
  <official_title>Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.&#xD;
&#xD;
      In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler&#xD;
      is a validated technique to study heart contractility. Its use in the analysis of diaphragm&#xD;
      function must be evaluated to determine its interest as a diagnostic tool.&#xD;
&#xD;
      Better understanding of diaphragm dysfunction following heart surgery will lead to earlier&#xD;
      management of post-operative respiratory complications and the implementation of preventive&#xD;
      pre-operative measures.&#xD;
&#xD;
      We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in&#xD;
      the assessment of diaphragm mobility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure diaphragm movement in TM (Time-Movement), in tissue Doppler</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">170</enrollment>
  <condition>Heart Surgery</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diaphragm ultrasonography</intervention_name>
    <description>Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces&#xD;
US mode:&#xD;
2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tissue Doppler</intervention_name>
    <description>Determine the threshold value for diaphragm mobility</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the post-operative period following heart surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-operative period following heart surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Existence of a neuro-muscular disease&#xD;
&#xD;
          -  Widened surgical approach&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Impossibility to see diaphragm movement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03295344
org study id: BOUARD ELLOUZE 2016
nct id: NCT03295344
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.

      In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler
      is a validated technique to study heart contractility. Its use in the analysis of diaphragm
      function must be evaluated to determine its interest as a diagnostic tool.

      Better understanding of diaphragm dysfunction following heart surgery will lead to earlier
      management of post-operative respiratory complications and the implementation of preventive
      pre-operative measures.

      We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in
      the assessment of diaphragm mobility.
observational model: Other
time perspective: Prospective
measure: Measure diaphragm movement in TM (Time-Movement), in tissue Doppler
time frame: At baseline
arm group label: Patients
arm group label: Healthy volunteers
intervention type: Other
intervention name: Diaphragm ultrasonography
description: Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces
US mode:
2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data
arm group label: Patients
intervention type: Other
intervention name: Tissue Doppler
description: Determine the threshold value for diaphragm mobility
arm group label: Healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor