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NCT03231072 Clinical Trial

Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03231072
Other study ID # Ventilation-EIT-PE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2017
Est. completion date March 30, 2022

Study information
Verified date July 2022
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date March 30, 2022
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Electrical Impedance Tomography record
Monitoring of pleural effusion evacuation by means of EIT

Locations
Country Name City State
Czechia The Military University Hospital Prague

Sponsors (2)
Lead Sponsor Collaborator
Czech Technical University in Prague Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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