Pleural EffusionNCT03231072
Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by EIT
A study testing Electrical Impedance Tomography record in people with Pleural Effusion and Drainage, run by Czech Technical University in Prague at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Drainage, Electric Impedance Tomography
- What is being tested?
- Electrical Impedance Tomography record
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Jan 2017to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation, presence of pleural effusion, decision of the treating physician to drain it
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusion, Drainage, Electric Impedance Tomography
- Being tested
- Electrical Impedance Tomography record
- Keywords
- mechanical ventilation, pleural effusion, EIT
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Tomography recordDevice
Monitoring of pleural effusion evacuation by means of EIT
| Study group | Role | What they receive |
|---|---|---|
| Electrical Impedance Tomography record | Experimental | Electrical Impedance Tomography monitoring of the pleural effusion evacuation. Receives: Device: Electrical Impedance Tomography record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (1)
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)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start31 Jan 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Prof., PhD., Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231072
- Sponsor's protocol ID
- Ventilation-EIT-PE
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2017
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25079591Mattison 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.
PubMed 9106583Goligher 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.
PubMed 21288334Alves 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.
PubMed 24308560
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Pleural Effusion Drainage in Mechanically Ventilated Patients Monitored by Electrical Impedance Tomography and End-Expiratory Lung Volume
- ClinicalTrials.gov ID
- NCT03231072
- Acronym / sponsor ID
- Ventilation-EIT-PE
- Conditions
- Pleural Effusion, Drainage, Electric Impedance Tomography
- Keywords
- mechanical ventilation, pleural effusion, EIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Impedance Tomography record | Experimental | Device: Electrical Impedance Tomography recordElectrical Impedance Tomography monitoring of the pleural effusion evacuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanical ventilation, presence of pleural effusion, decision of the treating physician to drain it
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance Tomography recordMonitoring of pleural effusion evacuation by means of EIT | Device | Electrical Impedance Tomography record |
Primary outcome
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
1 secondary outcome
Change of the distribution of ventilation following pleural effusion drainage in mechanically ventilated patients
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 25079591Razazi 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.
- Background: PubMed 9106583Mattison 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.
- Background: PubMed 21288334Goligher 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.
- Background: PubMed 24308560Alves 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubik, Prof., PhD. principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography record in people with Pleural Effusion and Drainage, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the thorax electrical impedance following pleural effusion drainage in mechanically ventilated patients (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231072, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.