Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume

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.

Study Overview

• Status: Completed
• Conditions: Drainage; Pleural Effusion; Electric Impedance Tomography
• Intervention / Treatment: Device: Electrical Impedance Tomography record

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
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 16902
    • The Military University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 hours

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Collaborators: Military University Hospital, Prague
• Investigators: Principal Investigator: Karel Roubik, Prof., PhD., Czech Technical University in Prague

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2017
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): March 30, 2022

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: mechanical ventilation; pleural effusion; EIT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: Ventilation-EIT-PE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No