Clinical Trial: Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 meas

Detailed Summary:
Sponsor: Medical University of Warsaw

Current Primary Outcome:

  • Change in intrapleural pressure [ Time Frame: Continuous measurement as a function of witdrawn 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 [ Time Frame: 6 hrs after completion of therapeutic thoracentesis ]


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Medical University of Warsaw

Dates:
Date Received: July 1, 2014
Date Started: April 2014
Date Completion: May 2016
Last Updated: July 14, 2014
Last Verified: June 2014