<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/NCT03231072</url>
  </required_header>
  <id_info>
    <org_study_id>Ventilation-EIT-PE</org_study_id>
    <nct_id>NCT03231072</nct_id>
  </id_info>
  <brief_title>Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT</brief_title>
  <official_title>Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Czech Technical University in Prague</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Military University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Czech Technical University in Prague</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>
      Evacuation of pleural effusion (PE) represents a disputable therapy in mechanically&#xD;
      ventilated patients. Patients on mechanical ventilation indicated by the physician to pleural&#xD;
      fluid evacuation will be monitored throughout the procedure by electrical impedance&#xD;
      tomography (EIT) and concurrently end-expiratory lung volume (EELV) will be measured in order&#xD;
      to describe impact of PE evacuation on aeration and ventilation of the lungs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients treated in intensive care units have a disorder of distribution and&#xD;
      volume of body fluids due to principal illness and some therapeutic interventions. One of its&#xD;
      manifestations is pleural effusion (PE) formation.&#xD;
&#xD;
      Patients on mechanical ventilation indicated by treating physician to pleural fluid&#xD;
      evacuation will be monitored throughout the procedure by electrical impedance tomography&#xD;
      (EIT) and concurrently end-expiratory lung volume (EELV) will be measured. The purpose of the&#xD;
      study is to better understand impact of PE evacuation on aeration and ventilation of the&#xD;
      lungs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients</measure>
    <time_frame>4 hours</time_frame>
    <description>Comparison of EIT results with end-expiratory lung volume measurement during drainage of pleural effusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients</measure>
    <time_frame>4 hours</time_frame>
    <description>Change of distribution of ventilation over EIT regions of interest (ROIs)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Drainage</condition>
  <condition>Electric Impedance Tomography</condition>
  <arm_group>
    <arm_group_label>Electrical Impedance Tomography record</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical Impedance Tomography monitoring of the pleural effusion evacuation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Impedance Tomography record</intervention_name>
    <description>Monitoring of pleural effusion evacuation by means of EIT</description>
    <arm_group_label>Electrical Impedance Tomography record</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mechanical ventilation, presence of pleural effusion, decision of the treating&#xD;
             physician to drain it&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  impossibility to apply EIT belt or to find suitable save point for drainage when the&#xD;
             EIT belt is attached&#xD;
&#xD;
          -  standard EIT exclusion criteria according to the device manufacturer&#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>Karel Roubik, Prof., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Czech Technical University in Prague</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Military University Hospital</name>
      <address>
        <city>Prague</city>
        <zip>16902</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Razazi K, Thille AW, Carteaux G, Beji O, Brun-Buisson C, Brochard L, Mekontso Dessap A. Effects of pleural effusion drainage on oxygenation, respiratory mechanics, and hemodynamics in mechanically ventilated patients. Ann Am Thorac Soc. 2014 Sep;11(7):1018-24. doi: 10.1513/AnnalsATS.201404-152OC.</citation>
    <PMID>25079591</PMID>
  </reference>
  <reference>
    <citation>Mattison LE, Coppage L, Alderman DF, Herlong JO, Sahn SA. Pleural effusions in the medical ICU: prevalence, causes, and clinical implications. Chest. 1997 Apr;111(4):1018-23. doi: 10.1378/chest.111.4.1018.</citation>
    <PMID>9106583</PMID>
  </reference>
  <reference>
    <citation>Goligher EC, Leis JA, Fowler RA, Pinto R, Adhikari NK, Ferguson ND. Utility and safety of draining pleural effusions in mechanically ventilated patients: a systematic review and meta-analysis. Crit Care. 2011;15(1):R46. doi: 10.1186/cc10009. Epub 2011 Feb 2.</citation>
    <PMID>21288334</PMID>
  </reference>
  <reference>
    <citation>Alves SH, Amato MB, Terra RM, Vargas FS, Caruso P. Lung reaeration and reventilation after aspiration of pleural effusions. A study using electrical impedance tomography. Ann Am Thorac Soc. 2014 Feb;11(2):186-91. doi: 10.1513/AnnalsATS.201306-142OC.</citation>
    <PMID>24308560</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mechanical ventilation</keyword>
  <keyword>pleural effusion</keyword>
  <keyword>EIT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</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/NCT03231072
org study id: Ventilation-EIT-PE
nct id: NCT03231072
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evacuation of pleural effusion (PE) represents a disputable therapy in mechanically
      ventilated patients. Patients on mechanical ventilation indicated by the physician to pleural
      fluid evacuation will be monitored throughout the procedure by electrical impedance
      tomography (EIT) and concurrently end-expiratory lung volume (EELV) will be measured in order
      to describe impact of PE evacuation on aeration and ventilation of the lungs.
Critically ill patients treated in intensive care units have a disorder of distribution and
      volume of body fluids due to principal illness and some therapeutic interventions. One of its
      manifestations is pleural effusion (PE) formation.

      Patients on mechanical ventilation indicated by treating physician to pleural fluid
      evacuation will be monitored throughout the procedure by electrical impedance tomography
      (EIT) and concurrently end-expiratory lung volume (EELV) will be measured. The purpose of the
      study is to better understand impact of PE evacuation on aeration and ventilation of the
      lungs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients
time frame: 4 hours
description: Comparison of EIT results with end-expiratory lung volume measurement during drainage of pleural effusion
measure: Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients
time frame: 4 hours
description: Change of distribution of ventilation over EIT regions of interest (ROIs)
arm group label: Electrical Impedance Tomography record
arm group type: Experimental
description: Electrical Impedance Tomography monitoring of the pleural effusion evacuation.
intervention type: Device
intervention name: Electrical Impedance Tomography record
description: Monitoring of pleural effusion evacuation by means of EIT
arm group label: Electrical Impedance Tomography record
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karel Roubik, Prof., PhD.
role: Principal Investigator
affiliation: Czech Technical University in Prague
facility: 
country: Czechia
citation: Razazi K, Thille AW, Carteaux G, Beji O, Brun-Buisson C, Brochard L, Mekontso Dessap A. Effects of pleural effusion drainage on oxygenation, respiratory mechanics, and hemodynamics in mechanically ventilated patients. Ann Am Thorac Soc. 2014 Sep;11(7):1018-24. doi: 10.1513/AnnalsATS.201404-152OC.
PMID: 25079591
citation: Mattison LE, Coppage L, Alderman DF, Herlong JO, Sahn SA. Pleural effusions in the medical ICU: prevalence, causes, and clinical implications. Chest. 1997 Apr;111(4):1018-23. doi: 10.1378/chest.111.4.1018.
PMID: 9106583
citation: Goligher EC, Leis JA, Fowler RA, Pinto R, Adhikari NK, Ferguson ND. Utility and safety of draining pleural effusions in mechanically ventilated patients: a systematic review and meta-analysis. Crit Care. 2011;15(1):R46. doi: 10.1186/cc10009. Epub 2011 Feb 2.
PMID: 21288334
citation: Alves SH, Amato MB, Terra RM, Vargas FS, Caruso P. Lung reaeration and reventilation after aspiration of pleural effusions. A study using electrical impedance tomography. Ann Am Thorac Soc. 2014 Feb;11(2):186-91. doi: 10.1513/AnnalsATS.201306-142OC.
PMID: 24308560
responsible party type: Sponsor
mesh term: Pleural Effusion
sharing ipd: No