Medical University of Warsaw
Warsaw, 02-097, Poland
NCT Number: NCT02192138
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Warsaw, 02-097, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Therapeutic thoracentesis with pleural fluid withdrawal
Time frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
Time frame: 6 hrs after completion of therapeutic thoracentesis
Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
Time frame: 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
Time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Time frame: Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
Lung function parameters measured by spirometry and body plethysmography
Time frame: 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.
Time frame: 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.
Time frame: 6 hrs after the completion of the therapeutic thoracentesis
Venous blood samples were collected for natriuretic peptides measurements.
Medical University of Warsaw
Other
Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
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