NCT03231072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

July 18, 2017

Last Update Submit

July 20, 2022

Conditions

Pleural EffusionDrainageElectric Impedance Tomography

Keywords

mechanical ventilationpleural effusionEIT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients

    4 hours

Study Arms (1)

Electrical Impedance Tomography record

EXPERIMENTAL

Electrical Impedance Tomography monitoring of the pleural effusion evacuation.

Device: Electrical Impedance Tomography record

Interventions

Electrical Impedance Tomography recordDEVICE

Monitoring of pleural effusion evacuation by means of EIT

Electrical Impedance Tomography record

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanical ventilation, presence of pleural effusion, decision of the treating physician to drain it

You may not qualify if:

  • impossibility to apply EIT belt or to find suitable save point for drainage when the EIT belt is attached

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Military University Hospital

Prague, 16902, Czechia

Location

Related Publications (4)

  • 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.

    PMID: 25079591BACKGROUND

  • 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.

    PMID: 9106583BACKGROUND

  • 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.

    PMID: 21288334BACKGROUND

  • 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.

    PMID: 24308560BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Karel Roubik, Prof., PhD.

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 27, 2017

Study Start

January 31, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)