<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/NCT04417790</url>
  </required_header>
  <id_info>
    <org_study_id>INT/IEC/2019/001513</org_study_id>
    <nct_id>NCT04417790</nct_id>
  </id_info>
  <brief_title>Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population</brief_title>
  <official_title>Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population- a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</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>
      Increased extravascular lung water (EVLW) may increase mortality and morbidity in&#xD;
      cardiopulmonary pathology. Many factors can cause increased extravascular lung water and&#xD;
      pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral&#xD;
      regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right&#xD;
      shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS)&#xD;
      and sepsis.&#xD;
&#xD;
      The clinical assessment of lung water ranges from auscultation to radiological methods to&#xD;
      invasive measurements like dye dilution or thermodilution studies.&#xD;
&#xD;
      Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung&#xD;
      water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as&#xD;
      well as the bedside gold standard, transpulmonary thermodilution in adults.&#xD;
&#xD;
      Critically ill children are more susceptible to complications and worsened outcomes from&#xD;
      increased EVLW.&#xD;
&#xD;
      Lung ultrasound correlates with clinical and radiological endpoints, but has not been&#xD;
      validated against invasive objective measures like transpulmonary thermodilution.&#xD;
&#xD;
      Evaluation of transpulmonary thermodilution setups in the pediatric population has shown&#xD;
      different normal values and cutoffs compared to adults, possibly due to differential rates&#xD;
      growth and development.&#xD;
&#xD;
      It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular&#xD;
      lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and&#xD;
      evaluate their sensitivity and specificity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2019</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.</measure>
    <time_frame>Till extubation or second post-operative day.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>cutoffs for lung USG B-line score to Predict abnormal EVLWI values.</measure>
    <time_frame>Till extubation or second post-operative day.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.</measure>
    <time_frame>Till extubation or second post-operative day.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Pulmonary Congestion</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Post-Op Complication</condition>
  <arm_group>
    <arm_group_label>Study population</arm_group_label>
    <description>Children under 12 years of age, Undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, Aristotle score ≤9, Giving prior written informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung ultrasound and EVLW measurement by transpulmonary thermodilution.</intervention_name>
    <description>Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement</description>
    <arm_group_label>Study population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged under 12 years,&#xD;
&#xD;
          -  undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart&#xD;
             disease,&#xD;
&#xD;
          -  Aristotle score ≤9,&#xD;
&#xD;
          -  with prior written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates,&#xD;
&#xD;
          -  Children with any chest wall deformity,&#xD;
&#xD;
          -  children with known lung disease, active infection,&#xD;
&#xD;
          -  those weighing less than 3.5 kg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bhupesh Kumar, DM</last_name>
    <role>Study Director</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Postgraduate Institute of Medical Education &amp; Research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr. Subhrashis Guha Niyogi</investigator_full_name>
    <investigator_title>Fellow, Cardiac Anaesthesia</investigator_title>
  </responsible_party>
  <keyword>Lung ultrasound</keyword>
  <keyword>Transpulmonary thermodilution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04417790
org study id: INT/IEC/2019/001513
nct id: NCT04417790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Increased extravascular lung water (EVLW) may increase mortality and morbidity in
      cardiopulmonary pathology. Many factors can cause increased extravascular lung water and
      pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral
      regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right
      shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS)
      and sepsis.

      The clinical assessment of lung water ranges from auscultation to radiological methods to
      invasive measurements like dye dilution or thermodilution studies.

      Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung
      water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as
      well as the bedside gold standard, transpulmonary thermodilution in adults.

      Critically ill children are more susceptible to complications and worsened outcomes from
      increased EVLW.

      Lung ultrasound correlates with clinical and radiological endpoints, but has not been
      validated against invasive objective measures like transpulmonary thermodilution.

      Evaluation of transpulmonary thermodilution setups in the pediatric population has shown
      different normal values and cutoffs compared to adults, possibly due to differential rates
      growth and development.

      It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular
      lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and
      evaluate their sensitivity and specificity.
observational model: Cohort
time perspective: Prospective
measure: correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
time frame: Till extubation or second post-operative day.
measure: cutoffs for lung USG B-line score to Predict abnormal EVLWI values.
time frame: Till extubation or second post-operative day.
measure: trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
time frame: Till extubation or second post-operative day.
arm group label: Study population
description: Children under 12 years of age, Undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, Aristotle score ≤9, Giving prior written informed consent.
intervention type: Diagnostic Test
intervention name: Lung ultrasound and EVLW measurement by transpulmonary thermodilution.
description: Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement
arm group label: Study population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
last name: Bhupesh Kumar, DM
role: Study Director
affiliation: Postgraduate Institute of Medical Education and Research
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr. Subhrashis Guha Niyogi
investigator title: Fellow, Cardiac Anaesthesia
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Postoperative Complications
sharing ipd: Undecided