<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/NCT03836183</url>
  </required_header>
  <id_info>
    <org_study_id>3-2018-EchoThorax</org_study_id>
    <nct_id>NCT03836183</nct_id>
  </id_info>
  <brief_title>Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation</brief_title>
  <acronym>Echo-Thorax</acronym>
  <official_title>Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Pro-arte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Pro-arte</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>
      Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which&#xD;
      is an invasive procedure. Although rare, several complications are known with, among other&#xD;
      things, the occurrence of pulmonary infections, pneumothorax associated with increased&#xD;
      pressure in the airways, atelectasis or bronchospasm.&#xD;
&#xD;
      Avoid the systematic control by fibroscopy in simple cases which makes it possible to&#xD;
      overcome the complications related to its use and its cost.&#xD;
&#xD;
      The investigators want to evaluate the diagnostic value of the echographic strategy in 2&#xD;
      steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left&#xD;
      upper lobe) associated with the clinical examination in preoperative by comparing with the&#xD;
      gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a&#xD;
      positive predictive value of at least 85%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In thoracic surgery, it is common to use selective intubation probes to exclude from&#xD;
      ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy&#xD;
      which is the reference examination to confirm the good position of these probes. The interest&#xD;
      of systematically controlling the good position of the left selective intubation probe by&#xD;
      fibroscopy is controversial.&#xD;
&#xD;
      The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in&#xD;
      resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and&#xD;
      atelectasis.&#xD;
&#xD;
      The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several&#xD;
      teams used it to ensure proper endotracheal tube positioning and to diagnose selective&#xD;
      intubation. In fact, it has been shown that to control the position of the probe more&#xD;
      precisely, ultrasound is more efficient than auscultation.&#xD;
&#xD;
      The aim of this work is to show by a large-scale prospective study that pleuropulmonary&#xD;
      ultrasound associated with the clinical examination confirms the exclusion of the operated&#xD;
      lung. the absence of systematic control of the positioning of the probe by fibroscopy allow&#xD;
      financial gain and a reduction in the risk of morbidity related to the realization of this&#xD;
      invasive gesture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2018</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.</measure>
    <time_frame>During peroperative period</time_frame>
    <description>The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures &lt; 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.</measure>
    <time_frame>During peroperative period</time_frame>
    <description>Only the presence of the two following non metric imaging criteria makes it possible to qualify the exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.</measure>
    <time_frame>at the end of the inclusion period, an average of 1 year</time_frame>
    <description>Number of participant with the presence of the two following non metric imaging criteria makes it possible to qualify the lung exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode. Evaluation on ultrasonographic loops blinded registered from bronchoscopy diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the surgeon's satisfaction with lung exclusion: visual analogue scale</measure>
    <time_frame>at the end of the surgery, day 1</time_frame>
    <description>Quantified satisfaction scale in visual analogue scale. (from 0: worse outcome, to 10: better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.</measure>
    <time_frame>During ultrasound</time_frame>
    <description>absence or presence of color in the pulmonary parenchyma on the 3 movements (pulmonary fields on the axillary line of the 2 sides and left upper lobe). The absence of color corresponding to a correct exclusion.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Thoracic</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ultrasound is the only study group for all the patients&#xD;
pleuropulmonary ultrasound&#xD;
clinical examination&#xD;
fibroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pleuropulmonary ultrasound with clinical examination</intervention_name>
    <description>Pleuropulmonary ultrasound associate with a clinical examination</description>
    <arm_group_label>ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient will benefit from thoracic or cardiac surgery requiring selective left&#xD;
             intubation.&#xD;
&#xD;
          -  Affiliation to the French social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Patients under guardianship, curators.&#xD;
&#xD;
          -  Surgery not compatible with a visualization of the pleural slip in echography: surgery&#xD;
             of pneumothorax or liquid effusion&#xD;
&#xD;
          -  History likely to disturb the detection of pleural slip on ultrasound: pneumothorax&#xD;
             surgery&#xD;
&#xD;
          -  Predictable intubation difficulties and the need for selective bronchial blocker&#xD;
             intubation&#xD;
&#xD;
          -  Pregnant or lactating women&#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>Alabaladejo Pierre</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu grenoble alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bronchoscopy</keyword>
  <keyword>ultrasound</keyword>
  <keyword>thorax</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/NCT03836183
org study id: 3-2018-EchoThorax
nct id: NCT03836183
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which
      is an invasive procedure. Although rare, several complications are known with, among other
      things, the occurrence of pulmonary infections, pneumothorax associated with increased
      pressure in the airways, atelectasis or bronchospasm.

      Avoid the systematic control by fibroscopy in simple cases which makes it possible to
      overcome the complications related to its use and its cost.

      The investigators want to evaluate the diagnostic value of the echographic strategy in 2
      steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left
      upper lobe) associated with the clinical examination in preoperative by comparing with the
      gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a
      positive predictive value of at least 85%.
In thoracic surgery, it is common to use selective intubation probes to exclude from
      ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy
      which is the reference examination to confirm the good position of these probes. The interest
      of systematically controlling the good position of the left selective intubation probe by
      fibroscopy is controversial.

      The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in
      resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and
      atelectasis.

      The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several
      teams used it to ensure proper endotracheal tube positioning and to diagnose selective
      intubation. In fact, it has been shown that to control the position of the probe more
      precisely, ultrasound is more efficient than auscultation.

      The aim of this work is to show by a large-scale prospective study that pleuropulmonary
      ultrasound associated with the clinical examination confirms the exclusion of the operated
      lung. the absence of systematic control of the positioning of the probe by fibroscopy allow
      financial gain and a reduction in the risk of morbidity related to the realization of this
      invasive gesture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.
time frame: During peroperative period
description: The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures < 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.
measure: to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.
time frame: During peroperative period
description: Only the presence of the two following non metric imaging criteria makes it possible to qualify the exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode.
measure: To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.
time frame: at the end of the inclusion period, an average of 1 year
description: Number of participant with the presence of the two following non metric imaging criteria makes it possible to qualify the lung exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode. Evaluation on ultrasonographic loops blinded registered from bronchoscopy diagnosis.
measure: Assess the surgeon's satisfaction with lung exclusion: visual analogue scale
time frame: at the end of the surgery, day 1
description: Quantified satisfaction scale in visual analogue scale. (from 0: worse outcome, to 10: better outcome)
measure: determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.
time frame: During ultrasound
description: absence or presence of color in the pulmonary parenchyma on the 3 movements (pulmonary fields on the axillary line of the 2 sides and left upper lobe). The absence of color corresponding to a correct exclusion.
arm group label: ultrasound
arm group type: Other
description: ultrasound is the only study group for all the patients
pleuropulmonary ultrasound
clinical examination
fibroscopy.
intervention type: Diagnostic Test
intervention name: Pleuropulmonary ultrasound with clinical examination
description: Pleuropulmonary ultrasound associate with a clinical examination
arm group label: ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alabaladejo Pierre
role: Principal Investigator
affiliation: CHU Grenoble Alpes
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No