Clinical trial NCT02192138: Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
Official title: Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Exudative Pleuritis
Keywords: Pleural effusion
Pleural fluid
Thoracentesis
Intrapleural pressure
Pleural manometry
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
First posted: 2014-07-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in intrapleural pressure
timeFrame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
measure: Intrapleural pressure
timeFrame: 6 hrs after completion of therapeutic thoracentesis
Secondary outcomes:
measure: Volume of withdrawn pleural fluid
timeFrame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Other outcomes:
measure: Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
timeFrame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
measure: Respiratory pattern including respiratory rate and tidal volume
timeFrame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes
measure: Change in lung function
timeFrame: Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
measure: Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
timeFrame: 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)
measure: Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
timeFrame: 6 hrs after the completion of therapeutic thoracentesis
measure: Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
timeFrame: 6 hrs after the completion of the therapeutic thoracentesis
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Rafal M Krenke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zielinska-Krawczyk M, Grabczak EM, Michnikowski M, Zielinski K, Korczynski P, Stecka A, Golczewski T, Krenke R. Patterns of pleural pressure amplitude and respiratory rate changes during therapeutic thoracentesis. BMC Pulm Med. 2018 Feb 14;18(1):36. doi: 10.1186/s12890-018-0595-7.
citation: Zielinska-Krawczyk M, Michnikowski M, Grabczak EM, Palko KJ, Korczynski P, Golczewski T, Krenke R. Cough during therapeutic thoracentesis: friend or foe? Respirology. 2015 Jan;20(1):166-8. doi: 10.1111/resp.12426. Epub 2014 Nov 3.