Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

Sponsor
Czech Technical University in Prague (Other)
Overall Status
Completed
CT.gov ID
NCT03231072
Collaborator
Military University Hospital, Prague (Other)
19
1
1
61.9
0.3

Study Details

Study Description

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
  • Device: Electrical Impedance Tomography record
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
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 :
Jan 31, 2017
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
Mar 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients [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 [4 hours]

    Change of distribution of ventilation over EIT regions of interest (ROIs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Military University Hospital Prague Czechia 16902

Sponsors and Collaborators

  • Czech Technical University in Prague
  • Military University Hospital, Prague

Investigators

  • Principal Investigator: Karel Roubik, Prof., PhD., Czech Technical University in Prague

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Czech Technical University in Prague
ClinicalTrials.gov Identifier:
NCT03231072
Other Study ID Numbers:
  • Ventilation-EIT-PE
First Posted:
Jul 27, 2017
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022