Exudative Pleuritis, Pleural Effusion
Conditions
Keywords
Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry
Brief 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.
Interventions
PROCEDURETherapeutic thoracentesis
Therapeutic thoracentesis with pleural fluid withdrawal
DEVICEPleural catheter
DEVICEPleural manometer
Sponsors
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. age 18 - 85 years, 2. pleural effusion occupying more than one third of the hemithorax on the posteroanterior chest radiograph, 3. therapeutic thoracentesis planned on the basis of signs and symptoms as well as imaging and functional studies, 4. no contraindications for thoracentesis, 5. signed informed consent for participation in the study.
Exclusion criteria
1. poor performance status requiring maximal shortening of the procedure, 2. instable hemodynamic or respiratory status unrelated to pleural effusion, 3. respiratory failure requiring mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intrapleural pressure | 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 | 6 hrs after completion of therapeutic thoracentesis | Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of withdrawn pleural fluid | Continuous measurement during therapeutic thoracentesis - up to 60 minutes | Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) | Baseline (approximately 15 minutes before thoracentesis) and at the end of therapeutic thoracentesis (10 minutes after completion of the procedure, i.e approximately 85 minutes after baseline measurement) | Venous blood samples were collected for natriuretic peptides measurements. |
| Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements | Continuous measurement during therapeutic thoracentesis - up to 60 minutes | 1\) baseline measurement 5 minutes 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), |
| Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) | 6 hrs after the completion of the therapeutic thoracentesis | Venous blood samples were collected for natriuretic peptides measurements. |
| Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements | 6 hrs after the completion of therapeutic thoracentesis | Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system. |
| Respiratory pattern including respiratory rate and tidal volume | Continuous measurement during therapeutic thoracentesis - up to 60 minutes | 1\) baseline measurement 5 minutes 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), |
| Change in lung function | Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis | Lung function parameters measured by spirometry and body plethysmography |
Countries
Poland
Outcome results
None listed