Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
Condition: Pleural Effusion; Exudative Pleuritis
MeSH terms: Pleural Effusion
Study type: Interventional

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.
    


Intervention name(s): Therapeutic thoracentesis; Pleural catheter; Pleural manometer
Intervention type(s): Procedure; Device; Device
Intervention description(s): Therapeutic thoracentesis with pleural fluid withdrawal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pleural effusion; Pleural fluid; Thoracentesis; Intrapleural pressure; Pleural manometry