Pleural EffusionNCT02192138
Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
A study testing Therapeutic thoracentesis, Pleural catheter and Pleural manometer in people with Pleural Effusion and Exudative Pleuritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Research project objectives. The project includes eight research hypotheses and eight corresponding study objectives. The most relevant objectives are: Analysis of lung function and gas exchange parameters in relation to the removed pleural fluid volume and intrapleural pressure changes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pleural Effusion, Exudative Pleuritis
- What is being tested?
- Therapeutic thoracentesis, Pleural catheter and Pleural manometer
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2014to Jan 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 85 years,
- pleural effusion occupying more than one third of the hemithorax on the posteroanterior chest radiograph,
- therapeutic thoracentesis planned on the basis of signs and symptoms as well as imaging and functional studies,
- no contraindications for thoracentesis,
- signed informed consent for participation in the study.
Who cannot join
- poor performance status requiring maximal shortening of the procedure,
- instable hemodynamic or respiratory status unrelated to pleural effusion,
- respiratory failure requiring mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
Research project objectives.
The project includes eight research hypotheses and eight corresponding study objectives. The most relevant objectives are:
Read more
- Analysis of lung function and gas exchange parameters in relation to the removed pleural fluid volume and intrapleural pressure changes.
- Evaluation of changes in lung and chest wall compliance and related changes in work of breathing during therapeutic thoracentesis and pleural fluid withdrawal.
- Study of the relationship between intrapleural pressure changes and cardiac function assessed by echocardiography and alterations in serum natriuretic peptide A and B concentration.
- Comparative analysis of the reliability of the volume-pressure curve slope prediction based on different variables measured before thoracentesis and real measurements of ventilation and intrapleural pressure during thoracentesis.
- Research methodology The study will be performed in 60 patients with pleural effusion planned for therapeutic thoracentesis.
Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide concentration.
Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable fluid drainage and intrapleural pressure measurement after completion of thoracentesis.
Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated in specific time points and compared in two subgroups (active physiotherapy to improve lung re-expansion and passive lung re-expansion).
Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the catheter will be removed.
Analysis.Signal analysis and visual multidimensional analysis performed with the use of own computer programs will be the first step of the analysis. The identified relationships between the analyzed parameters should allow to form physiological, medical, and statistical hypotheses, as well to verify the analysis of previously obtained data .
Expected impact of the research project The study results will allow to define lung function, blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some of these correlations had not been previously investigated. Our results may influence management standards in patients who require therapeutic thoracentesis.
- Conditions
- Pleural Effusion, Exudative Pleuritis
- Being tested
- Therapeutic thoracentesis, Pleural catheter, Pleural manometer
- Keywords
- Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic thoracentesisProcedure or surgery
Therapeutic thoracentesis with pleural fluid withdrawal
Pleural catheterDevice
Pleural manometerDevice
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic thoracentesis | Experimental | Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study Receives: Procedure: Therapeutic thoracentesis; Device: Pleural catheter; Device: Pleural manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intrapleural pressure
- baseline measurement before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),
Measured: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
Intrapleural pressure
Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
Measured: 6 hrs after completion of therapeutic thoracentesis
Secondary outcomes (1)
Volume of withdrawn pleural fluid
Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes
Measured: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Rafal M Krenke, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192138
- Sponsor's protocol ID
- IPU-DIMPA-WUM14(1)
- Status last verified
- Nov 2020
- First submitted
- 1 Jul 2014
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zielinska-Krawczyk M, Grabczak EM, Michnikowski M, Zielinski K, Korczynski P, Stecka A, Golczewski T, Krenke R. Patterns of pleural pressure amplitude and respiratory rate changes during therapeutic thoracentesis. BMC Pulm Med. 2018 Feb 14;18(1):36. doi: 10.1186/s12890-018-0595-7.
PubMed 29444649Zielinska-Krawczyk M, Michnikowski M, Grabczak EM, Palko KJ, Korczynski P, Golczewski T, Krenke R. Cough during therapeutic thoracentesis: friend or foe? Respirology. 2015 Jan;20(1):166-8. doi: 10.1111/resp.12426. Epub 2014 Nov 3.
PubMed 25367064
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
- ClinicalTrials.gov ID
- NCT02192138
- Acronym / sponsor ID
- IPU-DIMPA-WUM14(1)
- Conditions
- Pleural Effusion, Exudative Pleuritis
- Keywords
- Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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.
Research project objectives.
The project includes eight research hypotheses and eight corresponding study objectives. The most relevant objectives are:
- Analysis of lung function and gas exchange parameters in relation to the removed pleural fluid volume and intrapleural pressure changes.
- Evaluation of changes in lung and chest wall compliance and related changes in work of breathing during therapeutic thoracentesis and pleural fluid withdrawal.
- Study of the relationship between intrapleural pressure changes and cardiac function assessed by echocardiography and alterations in serum natriuretic peptide A and B concentration.
- Comparative analysis of the reliability of the volume-pressure curve slope prediction based on different variables measured before thoracentesis and real measurements of ventilation and intrapleural pressure during thoracentesis.
- Research methodology The study will be performed in 60 patients with pleural effusion planned for therapeutic thoracentesis.
Studies before thoracentesis: body plethysmography, spirometry, lung diffusion capacity (DLCO), arterial blood gases, 6 minute walk test, echocardiography, serum natriuretic peptide concentration.
Evaluation during thoracentesis: continuous measurement of tidal breathing and respiratory rate, measurement of removed pleural fluid volume and intrapleural pressure, transcutaneous measurement of PO2 and PCO2. Pleural catheter will be retained for the next 48hours to enable fluid drainage and intrapleural pressure measurement after completion of thoracentesis.
Monitoring during 48-hrs after thoracentesis: pre-thoracentesis measurements will be repeated in specific time points and compared in two subgroups (active physiotherapy to improve lung re-expansion and passive lung re-expansion).
Intrapleural pressure will be measured 24 and 48 hours after thoracentesis. Then, the catheter will be removed.
Analysis.Signal analysis and visual multidimensional analysis performed with the use of own computer programs will be the first step of the analysis. The identified relationships between the analyzed parameters should allow to form physiological, medical, and statistical hypotheses, as well to verify the analysis of previously obtained data .
Expected impact of the research project The study results will allow to define lung function, blood gases and cardiovascular function in relation to changes in intrapleural pressure. Some of these correlations had not been previously investigated. Our results may influence management standards in patients who require therapeutic thoracentesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic thoracentesis | Experimental | Procedure: Therapeutic thoracentesis, Device: Pleural catheter, Device: Pleural manometerPatients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 - 85 years,
- pleural effusion occupying more than one third of the hemithorax on the posteroanterior chest radiograph,
- therapeutic thoracentesis planned on the basis of signs and symptoms as well as imaging and functional studies,
- no contraindications for thoracentesis,
- signed informed consent for participation in the study.
Key exclusion criteria (3 listed)
- poor performance status requiring maximal shortening of the procedure,
- instable hemodynamic or respiratory status unrelated to pleural effusion,
- respiratory failure requiring mechanical ventilation.
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 |
|---|---|---|
| Therapeutic thoracentesisTherapeutic thoracentesis with pleural fluid withdrawal | Procedure or surgery | Therapeutic thoracentesis |
| Pleural catheter | Device | Therapeutic thoracentesis |
| Pleural manometer | Device | Therapeutic thoracentesis |
Primary outcome
Change in intrapleural pressure
Time frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
1) baseline measurement before pleural fluid withdrawal, 2) continuous measurement during pleural fluid withdrawal, 3) measurement 1 minute after termination of pleural fluid withdrawal (the end of the procedure),
Intrapleural pressure
Time frame: 6 hrs after completion of therapeutic thoracentesis
Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
1 secondary outcome
Volume of withdrawn pleural fluid
Time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
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 18 Nov 2020.
- Derived from this study: PubMed 29444649Zielinska-Krawczyk M, Grabczak EM, Michnikowski M, Zielinski K, Korczynski P, Stecka A, Golczewski T, Krenke R. Patterns of pleural pressure amplitude and respiratory rate changes during therapeutic thoracentesis. BMC Pulm Med. 2018 Feb 14;18(1):36. doi: 10.1186/s12890-018-0595-7.
- Derived from this study: PubMed 25367064Zielinska-Krawczyk M, Michnikowski M, Grabczak EM, Palko KJ, Korczynski P, Golczewski T, Krenke R. Cough during therapeutic thoracentesis: friend or foe? Respirology. 2015 Jan;20(1):166-8. doi: 10.1111/resp.12426. Epub 2014 Nov 3.
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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.
Rafal M Krenke, MD, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic thoracentesis, Pleural catheter and Pleural manometer in people with Pleural Effusion and Exudative Pleuritis, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 3 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 18 Nov 2020. 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 Poland. 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 in intrapleural pressure (time frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes). The study lists 2 primary outcomes in all. 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 NCT02192138, which also lists 2 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 18 Nov 2020.