<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/NCT02192138</url>
  </required_header>
  <id_info>
    <org_study_id>IPU-DIMPA-WUM14(1)</org_study_id>
    <nct_id>NCT02192138</nct_id>
  </id_info>
  <brief_title>Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis</brief_title>
  <official_title>Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Warsaw</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>
      Research project objectives.&#xD;
&#xD;
      The project includes eight research hypotheses and eight corresponding study objectives. The&#xD;
      most relevant objectives are:&#xD;
&#xD;
        -  Analysis of lung function and gas exchange parameters in relation to the removed pleural&#xD;
           fluid volume and intrapleural pressure changes.&#xD;
&#xD;
        -  Evaluation of changes in lung and chest wall compliance and related changes in work of&#xD;
           breathing during therapeutic thoracentesis and pleural fluid withdrawal.&#xD;
&#xD;
        -  Study of the relationship between intrapleural pressure changes and cardiac function&#xD;
           assessed by echocardiography and alterations in serum natriuretic peptide A and B&#xD;
           concentration.&#xD;
&#xD;
        -  Comparative analysis of the reliability of the volume-pressure curve slope prediction&#xD;
           based on different variables measured before thoracentesis and real measurements of&#xD;
           ventilation and intrapleural pressure during thoracentesis.&#xD;
&#xD;
           2. Research methodology The study will be performed in 60 patients with pleural effusion&#xD;
           planned for therapeutic thoracentesis.&#xD;
&#xD;
      Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity&#xD;
      (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide&#xD;
      concentration.&#xD;
&#xD;
      Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory&#xD;
      rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous&#xD;
      measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable&#xD;
      fluid drainage and intrapleural pressure measurement after completion of thoracentesis.&#xD;
&#xD;
      Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated&#xD;
      in specific time points and compared in two subgroups (active physiotherapy to improve lung&#xD;
      re-expansion and passive lung re-expansion).&#xD;
&#xD;
      Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the&#xD;
      catheter will be removed.&#xD;
&#xD;
      Analysis.Signal analysis and visual multidimensional analysis performed with the use of own&#xD;
      computer programs will be the first step of the analysis. The identified relationships&#xD;
      between the analyzed parameters should allow to form physiological, medical, and statistical&#xD;
      hypotheses, as well to verify the analysis of previously obtained data .&#xD;
&#xD;
      Expected impact of the research project The study results will allow to define lung function,&#xD;
      blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some&#xD;
      of these correlations had not been previously investigated. Our results may influence&#xD;
      management standards in patients who require therapeutic thoracentesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in intrapleural pressure</measure>
    <time_frame>Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes</time_frame>
    <description>1) baseline measurement before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrapleural pressure</measure>
    <time_frame>6 hrs after completion of therapeutic thoracentesis</time_frame>
    <description>Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volume of withdrawn pleural fluid</measure>
    <time_frame>Continuous measurement during therapeutic thoracentesis - up to 60 minutes</time_frame>
    <description>Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements</measure>
    <time_frame>Continuous measurement during therapeutic thoracentesis - up to 60 minutes</time_frame>
    <description>1) baseline measurement 5 minutes before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory pattern including respiratory rate and tidal volume</measure>
    <time_frame>Continuous measurement during therapeutic thoracentesis - up to 60 minutes</time_frame>
    <description>1) baseline measurement 5 minutes before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in lung function</measure>
    <time_frame>Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis</time_frame>
    <description>Lung function parameters measured by spirometry and body plethysmography</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)</measure>
    <time_frame>Baseline (approximately 15 minutes before thoracentesis) and at the end of therapeutic thoracentesis (10 minutes after completion of the procedure, i.e approximately 85 minutes after baseline measurement)</time_frame>
    <description>Venous blood samples were collected for natriuretic peptides measurements.</description>
  </other_outcome>
  <other_outcome>
    <measure>Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements</measure>
    <time_frame>6 hrs after the completion of therapeutic thoracentesis</time_frame>
    <description>Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system.</description>
  </other_outcome>
  <other_outcome>
    <measure>Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)</measure>
    <time_frame>6 hrs after the completion of the therapeutic thoracentesis</time_frame>
    <description>Venous blood samples were collected for natriuretic peptides measurements.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Exudative Pleuritis</condition>
  <arm_group>
    <arm_group_label>Therapeutic thoracentesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic thoracentesis</intervention_name>
    <description>Therapeutic thoracentesis with pleural fluid withdrawal</description>
    <arm_group_label>Therapeutic thoracentesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pleural catheter</intervention_name>
    <arm_group_label>Therapeutic thoracentesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pleural manometer</intervention_name>
    <arm_group_label>Therapeutic thoracentesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18 - 85 years,&#xD;
&#xD;
          2. pleural effusion occupying more than one third of the hemithorax on the&#xD;
             posteroanterior chest radiograph,&#xD;
&#xD;
          3. therapeutic thoracentesis planned on the basis of signs and symptoms as well as&#xD;
             imaging and functional studies,&#xD;
&#xD;
          4. no contraindications for thoracentesis,&#xD;
&#xD;
          5. signed informed consent for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. poor performance status requiring maximal shortening of the procedure,&#xD;
&#xD;
          2. instable hemodynamic or respiratory status unrelated to pleural effusion,&#xD;
&#xD;
          3. respiratory failure requiring mechanical ventilation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafal M Krenke, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pleural effusion</keyword>
  <keyword>Pleural fluid</keyword>
  <keyword>Thoracentesis</keyword>
  <keyword>Intrapleural pressure</keyword>
  <keyword>Pleural manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <!-- 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/NCT02192138
org study id: IPU-DIMPA-WUM14(1)
nct id: NCT02192138
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research project objectives.

      The project includes eight research hypotheses and eight corresponding study objectives. The
      most relevant objectives are:

        -  Analysis of lung function and gas exchange parameters in relation to the removed pleural
           fluid volume and intrapleural pressure changes.

        -  Evaluation of changes in lung and chest wall compliance and related changes in work of
           breathing during therapeutic thoracentesis and pleural fluid withdrawal.

        -  Study of the relationship between intrapleural pressure changes and cardiac function
           assessed by echocardiography and alterations in serum natriuretic peptide A and B
           concentration.

        -  Comparative analysis of the reliability of the volume-pressure curve slope prediction
           based on different variables measured before thoracentesis and real measurements of
           ventilation and intrapleural pressure during thoracentesis.

           2. Research methodology The study will be performed in 60 patients with pleural effusion
           planned for therapeutic thoracentesis.

      Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity
      (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide
      concentration.

      Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory
      rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous
      measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable
      fluid drainage and intrapleural pressure measurement after completion of thoracentesis.

      Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated
      in specific time points and compared in two subgroups (active physiotherapy to improve lung
      re-expansion and passive lung re-expansion).

      Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the
      catheter will be removed.

      Analysis.Signal analysis and visual multidimensional analysis performed with the use of own
      computer programs will be the first step of the analysis. The identified relationships
      between the analyzed parameters should allow to form physiological, medical, and statistical
      hypotheses, as well to verify the analysis of previously obtained data .

      Expected impact of the research project The study results will allow to define lung function,
      blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some
      of these correlations had not been previously investigated. Our results may influence
      management standards in patients who require therapeutic thoracentesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in intrapleural pressure
time frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
description: 1) baseline measurement before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),
measure: Intrapleural pressure
time frame: 6 hrs after completion of therapeutic thoracentesis
description: Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
measure: Volume of withdrawn pleural fluid
time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
description: Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes
measure: Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
description: 1) baseline measurement 5 minutes before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),
measure: Respiratory pattern including respiratory rate and tidal volume
time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
description: 1) baseline measurement 5 minutes before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),
measure: Change in lung function
time frame: Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
description: Lung function parameters measured by spirometry and body plethysmography
measure: Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
time frame: Baseline (approximately 15 minutes before thoracentesis) and at the end of therapeutic thoracentesis (10 minutes after completion of the procedure, i.e approximately 85 minutes after baseline measurement)
description: Venous blood samples were collected for natriuretic peptides measurements.
measure: Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
time frame: 6 hrs after the completion of therapeutic thoracentesis
description: Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system.
measure: Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
time frame: 6 hrs after the completion of the therapeutic thoracentesis
description: Venous blood samples were collected for natriuretic peptides measurements.
arm group label: Therapeutic thoracentesis
arm group type: Experimental
description: Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study
intervention type: Procedure
intervention name: Therapeutic thoracentesis
description: Therapeutic thoracentesis with pleural fluid withdrawal
arm group label: Therapeutic thoracentesis
intervention type: Device
intervention name: Pleural catheter
arm group label: Therapeutic thoracentesis
intervention type: Device
intervention name: Pleural manometer
arm group label: Therapeutic thoracentesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rafal M Krenke, MD, PhD
role: Principal Investigator
affiliation: Medical University of Warsaw
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Pleural Effusion