Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

Study Overview
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Brief Summary
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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.

Official Title
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Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis

Conditions
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Pleural Effusion, Exudative Pleuritis

Intervention / Treatment
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* Procedure: Therapeutic thoracentesis
* Device: Pleural catheter
* Device: Pleural manometer


Participation Criteria
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Eligibility Criteria
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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, instable hemodynamic or respiratory status unrelated to pleural effusion, respiratory failure requiring mechanical ventilation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic thoracentesis<br>Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study | Procedure: Therapeutic thoracentesis<br>* Therapeutic thoracentesis with pleural fluid withdrawal<br>Device: Pleural catheter<br> <br> Device: Pleural manometer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intrapleural pressure | 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), | 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. | 6 hrs after completion of therapeutic thoracentesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of withdrawn pleural fluid | Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes | Continuous measurement during therapeutic thoracentesis - up to 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry