search
Back to results

Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

Primary Purpose

Pleural Effusion, Drainage, Electric Impedance Tomography

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Electrical Impedance Tomography record
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion focused on measuring mechanical ventilation, pleural effusion, EIT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Military University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Impedance Tomography record

Arm Description

Electrical Impedance Tomography monitoring of the pleural effusion evacuation.

Outcomes

Primary Outcome Measures

Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients
Comparison of EIT results with end-expiratory lung volume measurement during drainage of pleural effusion

Secondary Outcome Measures

Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients
Change of distribution of ventilation over EIT regions of interest (ROIs)

Full Information

First Posted
July 18, 2017
Last Updated
July 20, 2022
Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
search

1. Study Identification

Unique Protocol Identification Number
NCT03231072
Brief Title
Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT
Official Title
Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Drainage, Electric Impedance Tomography
Keywords
mechanical ventilation, pleural effusion, EIT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical Impedance Tomography record
Arm Type
Experimental
Arm Description
Electrical Impedance Tomography monitoring of the pleural effusion evacuation.
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Tomography record
Intervention Description
Monitoring of pleural effusion evacuation by means of EIT
Primary Outcome Measure Information:
Title
Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients
Description
Comparison of EIT results with end-expiratory lung volume measurement during drainage of pleural effusion
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients
Description
Change of distribution of ventilation over EIT regions of interest (ROIs)
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubik, Prof., PhD.
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Military University Hospital
City
Prague
ZIP/Postal Code
16902
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25079591
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.
Results Reference
background
PubMed Identifier
9106583
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.
Results Reference
background
PubMed Identifier
21288334
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.
Results Reference
background
PubMed Identifier
24308560
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.
Results Reference
background

Learn more about this trial

Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

We'll reach out to this number within 24 hrs