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Completed

NCT Number: NCT02192138

Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, 02-097, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic thoracentesis

Procedure

Therapeutic thoracentesis with pleural fluid withdrawal

Pleural catheter

Device

Pleural manometer

Device

Primary outcomes

  1. Change in intrapleural pressure

    Time frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes

    • 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),
  2. Intrapleural pressure

    Time frame: 6 hrs after completion of therapeutic thoracentesis

    Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.

Secondary outcomes

  1. Volume of withdrawn pleural fluid

    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

Other outcomes

  1. Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements

    Time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes

    • 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),
  2. Respiratory pattern including respiratory rate and tidal volume

    Time frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes

    • 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),
  3. Change in lung function

    Time frame: Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis

    Lung function parameters measured by spirometry and body plethysmography

  4. Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)

    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.

  5. Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) 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.

  6. Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)

    Time frame: 6 hrs after the completion of the therapeutic thoracentesis

    Venous blood samples were collected for natriuretic peptides measurements.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2014
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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