xml: <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/NCT06009731</url>
    </required_header>
    <id_info>
      <org_study_id>PI2023_843_0040</org_study_id>
      <nct_id>NCT06009731</nct_id>
    </id_info>
    <brief_title>Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial</brief_title>
    <acronym>DIAST</acronym>
    <official_title>DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire, Amiens</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire, Amiens</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>
        Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric&#xD;
        balloons is the gold standard for the assessment of diaphragmatic effort. This technique is&#xD;
        relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal&#xD;
        strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment&#xD;
        of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic&#xD;
        dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no&#xD;
        assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to&#xD;
        evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic&#xD;
        thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters&#xD;
        will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early'&#xD;
        assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the&#xD;
        beginning of the SBT.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial</measure>
      <time_frame>7 days</time_frame>
      <description>diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial</measure>
      <time_frame>7 days</time_frame>
      <description>diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Weaning</condition>
    <condition>Spontaneous Breathing Trial</condition>
    <condition>Mechanical Ventilation</condition>
    <condition>Speckle Tracking</condition>
    <condition>Strains</condition>
    <condition>Diaphragm</condition>
    <arm_group>
      <arm_group_label>adult patients undergoing mechanical ventilation</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least&#xD;
          24h (regardless of the reason of intubation) and fulfilling criteria for an SBT will be&#xD;
          included in the study. Briefly, to be eligible for an SBT, patients will have to (i) be&#xD;
          able to trigger ventilator breaths with a reasonable level of assistance, (ii) lack of&#xD;
          severe impairment in gas exchange, and (iii) not require significant hemodynamic support.&#xD;
          Patients will be recruited by the study coordinator following completion of informed&#xD;
          consent from the patient or legally authorized substitute decision maker.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at&#xD;
               least 24h (regardless of the reason of intubation)&#xD;
  &#xD;
            -  patients fulfilling criteria for an SBT&#xD;
  &#xD;
            -  patients will have to be able to trigger ventilator breaths with a reasonable level of&#xD;
               assistance,&#xD;
  &#xD;
            -  patients with lack of severe impairment in gas exchange,&#xD;
  &#xD;
            -  patients that not require significant hemodynamic support.&#xD;
  &#xD;
            -  Patients will be recruited by the study coordinator following completion of informed&#xD;
               consent from the patient or legally authorized substitute decision maker.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of pressure support during the SBT.&#xD;
  &#xD;
            -  Severe hemodynamic instability (&gt;30% increase in vasopressors in the last 6 hours or&#xD;
               norepinephrine &gt; 0.5 µg/kg/min).&#xD;
  &#xD;
            -  Severe or very severe chronic obstructive pulmonary disease (COPD) according to the&#xD;
               GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 &lt; 30% predicted).&#xD;
  &#xD;
            -  Known or suspected severe or progressive neuromuscular disorder likely to result in&#xD;
               prolonged or chronic ventilator dependence&#xD;
  &#xD;
            -  Clinical judgement of the attending physician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Clément Brault, MD</last_name>
      <phone>03 22 08 89 09</phone>
      <email>brault.clement@chu-amiens.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Amiens</name>
        <address>
          <city>Amiens</city>
          <zip>80480</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clement Brault, MD</last_name>
      </contact>
      <investigator>
        <last_name>Yoann Zerbib, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Julien Maizel, Pr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Michel Slama, Pr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>weaning</keyword>
    <keyword>spontaneous breathing trial</keyword>
    <keyword>mechanical ventilation</keyword>
    <keyword>speckle tracking</keyword>
    <keyword>Strains</keyword>
    <keyword>diaphragm</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009731
  org study id: PI2023_843_0040
  nct id: NCT06009731
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric
        balloons is the gold standard for the assessment of diaphragmatic effort. This technique is
        relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal
        strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment
        of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic
        dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no
        assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to
        evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic
        thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters
        will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early'
        assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the
        beginning of the SBT.
  observational model: Case-Only
  time perspective: Prospective
  measure: changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial
  time frame: 7 days
  description: diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT
  measure: changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial
  time frame: 7 days
  description: diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT
  arm group label: adult patients undergoing mechanical ventilation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Clément Brault, MD
  phone: 03 22 08 89 09
  email: brault.clement@chu-amiens.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration
  sharing ipd: No