Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT

Overview

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.

Full Title of Study: “Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Electrical Impedance Tomography record
    • Electrical Impedance Tomography monitoring of the pleural effusion evacuation.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Czech Technical University in Prague
  • Collaborator
    • Military University Hospital, Prague
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karel Roubik, Prof., PhD., Principal Investigator, Czech Technical University in Prague

References

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.

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