<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/NCT03817918</url>
  </required_header>
  <id_info>
    <org_study_id>18.304</org_study_id>
    <nct_id>NCT03817918</nct_id>
  </id_info>
  <brief_title>A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.</brief_title>
  <acronym>STRAIN-VUP</acronym>
  <official_title>A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia Using One-lung Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
      Mechanical ventilation is frequently used in the operating room and the intensive care&#xD;
      settings. Although essential in many cases, mechanical ventilation can be responsible for&#xD;
      ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and&#xD;
      VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative&#xD;
      mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently&#xD;
      observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary&#xD;
      disease can increase the risk of overdistension. The development of a tool allowing early&#xD;
      detection of pulmonary overdistension would represent a great asset in the prevention of VILI&#xD;
      by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging&#xD;
      is a non-radiant, non-invasive technique already available in the intensive care setting.&#xD;
      Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess&#xD;
      pulmonary strain.&#xD;
&#xD;
      This pilot study will aim to create a small dataset of local pleural strain values assessed&#xD;
      at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic&#xD;
      surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale&#xD;
      studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At four different time points during thoracic surgery, images of the pleura of the dependent&#xD;
      lung will be made at 2 predetermined areas. The images will be made: after induction (tidal&#xD;
      volume of 10 mL/kg), during two-lung ventilation (tidal volume of 10 mL/kg) and during&#xD;
      one-lung ventilation (tidal volume of 10 mL/kg and 5 mL/kg). The sites to be studied will be:&#xD;
      the 3rd intercostal space at the mid-clavicular line (dependent lung), the 8th intercostal&#xD;
      space at the posterior axillary line (dependent lung). Three consecutive respiratory cycles&#xD;
      at each site will be recorded for subsequent analysis.&#xD;
&#xD;
      Lung ultrasonography will be performed by the principal investigator and a co-investigator&#xD;
      using a Terason (Teratech Corporation, Burlington, MA) device and a 12L5 linear ultrasound&#xD;
      probe. For each image, the probe will be oriented perpendicularly to the pleura with the&#xD;
      pointer towards the participant's head. A depth of 4 cm will be used and adjusted in order to&#xD;
      have the pleural line located between the center and the three-quarts of the screen. The&#xD;
      beam's focal zone will be positioned at the level of the pleural line. A 12 MHz frequency&#xD;
      will be used.&#xD;
&#xD;
      Using a reference ultrasonographic image, an experienced lung ultrasonographer will segment&#xD;
      the pleura. From this image, an algorithm will define a region of interest which will be&#xD;
      followed throughout the rest of the images of the video sequence. Thereafter, the algorithm&#xD;
      will calculate the various components of pulmonary strain in relation to tidal volume. The&#xD;
      principal investigator or a co-investigator will visually validate the speckle-tracking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 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>
    <intervention_model_description>Prospective, interventional, cohort study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the measurement of local pleural strain using ultrasonography</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Proportion of successfully analyzed lung ultrasonographic clips</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average absolute lateral deformation</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Change in percentage from baseline expiratory values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulated range of absolute lateral deformation</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Change in percentage from baseline expiratory values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average absolute lateral shift</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Change in percentage from baseline expiratory values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulated range of absolute lateral shift</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Change in percentage from baseline expiratory values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average von mises</measure>
    <time_frame>At the end of the study on Day 1</time_frame>
    <description>Change in percentage from baseline expiratory values</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Ventilator-Induced Lung Injury</condition>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>Determination of local pleural strain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung ultrasonography</intervention_name>
    <description>Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points</description>
    <arm_group_label>Determination of local pleural strain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing thoracic surgery in lateral position requiring one-lung&#xD;
             ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity (Body Mass Index superior to 30 kg/m2)&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)&#xD;
&#xD;
          -  Previous participation to the study&#xD;
&#xD;
          -  Patient refusal&#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>Martin Girard, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
  </condition_browse>
  <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/NCT03817918
org study id: 18.304
nct id: NCT03817918
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mechanical ventilation is frequently used in the operating room and the intensive care
      settings. Although essential in many cases, mechanical ventilation can be responsible for
      ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and
      VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative
      mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently
      observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary
      disease can increase the risk of overdistension. The development of a tool allowing early
      detection of pulmonary overdistension would represent a great asset in the prevention of VILI
      by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging
      is a non-radiant, non-invasive technique already available in the intensive care setting.
      Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess
      pulmonary strain.

      This pilot study will aim to create a small dataset of local pleural strain values assessed
      at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic
      surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale
      studies.
At four different time points during thoracic surgery, images of the pleura of the dependent
      lung will be made at 2 predetermined areas. The images will be made: after induction (tidal
      volume of 10 mL/kg), during two-lung ventilation (tidal volume of 10 mL/kg) and during
      one-lung ventilation (tidal volume of 10 mL/kg and 5 mL/kg). The sites to be studied will be:
      the 3rd intercostal space at the mid-clavicular line (dependent lung), the 8th intercostal
      space at the posterior axillary line (dependent lung). Three consecutive respiratory cycles
      at each site will be recorded for subsequent analysis.

      Lung ultrasonography will be performed by the principal investigator and a co-investigator
      using a Terason (Teratech Corporation, Burlington, MA) device and a 12L5 linear ultrasound
      probe. For each image, the probe will be oriented perpendicularly to the pleura with the
      pointer towards the participant's head. A depth of 4 cm will be used and adjusted in order to
      have the pleural line located between the center and the three-quarts of the screen. The
      beam's focal zone will be positioned at the level of the pleural line. A 12 MHz frequency
      will be used.

      Using a reference ultrasonographic image, an experienced lung ultrasonographer will segment
      the pleura. From this image, an algorithm will define a region of interest which will be
      followed throughout the rest of the images of the video sequence. Thereafter, the algorithm
      will calculate the various components of pulmonary strain in relation to tidal volume. The
      principal investigator or a co-investigator will visually validate the speckle-tracking.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, interventional, cohort study
primary purpose: Other
masking: None (Open Label)
measure: Feasibility of the measurement of local pleural strain using ultrasonography
time frame: At the end of the study on Day 1
description: Proportion of successfully analyzed lung ultrasonographic clips
measure: Average absolute lateral deformation
time frame: At the end of the study on Day 1
description: Change in percentage from baseline expiratory values
measure: Cumulated range of absolute lateral deformation
time frame: At the end of the study on Day 1
description: Change in percentage from baseline expiratory values
measure: Average absolute lateral shift
time frame: At the end of the study on Day 1
description: Change in percentage from baseline expiratory values
measure: Cumulated range of absolute lateral shift
time frame: At the end of the study on Day 1
description: Change in percentage from baseline expiratory values
measure: Average von mises
time frame: At the end of the study on Day 1
description: Change in percentage from baseline expiratory values
arm group label: Determination of local pleural strain
arm group type: Experimental
description: The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography
intervention type: Procedure
intervention name: Lung ultrasonography
description: Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points
arm group label: Determination of local pleural strain
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Girard, MD, FRCPC
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Injury
mesh term: Ventilator-Induced Lung Injury
sharing ipd: No