CompletedNot Applicable

Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

Poland61 participantsStarted 2014-08

Plain-language 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. * 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. 2\. 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

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Inclusion criteria

. 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.

Exclusion criteria

. poor performance status requiring maximal shortening of the procedure,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in intrapleural pressure

Timeframe: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes

Intrapleural pressure

Timeframe: 6 hrs after completion of therapeutic thoracentesis

Trial details

NCT IDNCT02192138

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Pleural Effusion trials