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Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

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ClinicalTrials.gov Identifier: NCT03231072
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Military University Hospital, Prague
Information provided by (Responsible Party):
Czech Technical University in Prague

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Drainage Electric Impedance Tomography Device: Electrical Impedance Tomography record Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Electrical Impedance Tomography record
Electrical Impedance Tomography monitoring of the pleural effusion evacuation.
Device: Electrical Impedance Tomography record
Monitoring of pleural effusion evacuation by means of EIT




Primary Outcome Measures :
  1. Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients [ Time Frame: 4 hours ]
    Comparison of EIT results with end-expiratory lung volume measurement during drainage of pleural effusion


Secondary Outcome Measures :
  1. Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients [ Time Frame: 4 hours ]
    Change of distribution of ventilation over EIT regions of interest (ROIs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanical ventilation, presence of pleural effusion, decision of the treating physician to drain it

Exclusion Criteria:

  • impossibility to apply EIT belt or to find suitable save point for drainage when the EIT belt is attached
  • standard EIT exclusion criteria according to the device manufacturer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231072


Contacts
Contact: Ales Rara, M.D. +420973202999 raraales@uvn.cz
Contact: Karel Roubik, Prof., PhD. +420973202999 roubik@fbmi.cvut.cz

Locations
Czechia
The Military University Hospital Recruiting
Prague, Czechia, 16902
Contact: Ales Rara, M.D.       raraales@uvn.cz   
Contact: Martin Müller, M.D.       mullermartin@uvn.cz   
Sponsors and Collaborators
Czech Technical University in Prague
Military University Hospital, Prague
Investigators
Principal Investigator: Karel Roubik, Prof., PhD. Czech Technical University in Prague

Publications:
Responsible Party: Czech Technical University in Prague
ClinicalTrials.gov Identifier: NCT03231072     History of Changes
Other Study ID Numbers: Ventilation-EIT-PE
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Czech Technical University in Prague:
mechanical ventilation
pleural effusion
EIT

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases