Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192138
• Other study ID #: IPU-DIMPA-WUM14(1)
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 2019

Study information

• Verified date: November 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exudative Pleuritis
• Pleural Effusion

Intervention

Procedure:
• Therapeutic thoracentesis
Therapeutic thoracentesis with pleural fluid withdrawal

Device:
• Pleural catheter

• Pleural manometer

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements	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),	Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Other	Respiratory pattern including respiratory rate and tidal volume	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),	Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Other	Change in lung function	Lung function parameters measured by spirometry and body plethysmography	Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
Other	Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)	Venous blood samples were collected for natriuretic peptides measurements.	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)
Other	Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements	Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system.	6 hrs after the completion of therapeutic thoracentesis
Other	Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)	Venous blood samples were collected for natriuretic peptides measurements.	6 hrs after the completion of the therapeutic thoracentesis
Primary	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
Primary	Intrapleural pressure	Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.	6 hrs after completion of therapeutic thoracentesis
Secondary	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