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Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

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ClinicalTrials.gov Identifier: NCT02192138
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Pleural Effusion Exudative Pleuritis Procedure: Therapeutic thoracentesis Device: Pleural catheter Device: Pleural manometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
Study Start Date : April 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Therapeutic thoracentesis
Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study
Procedure: Therapeutic thoracentesis
Therapeutic thoracentesis with pleural fluid withdrawal

Device: Pleural catheter
Device: Pleural manometer



Primary Outcome Measures :
  1. Change in intrapleural pressure [ Time Frame: Continuous measurement as a function of withdrawn 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),

  2. Intrapleural pressure [ Time Frame: 6 hrs after completion of therapeutic thoracentesis ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]
    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),

  2. Respiratory pattern including respiratory rate and tidal volume [ Time Frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes ]
    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),

  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) ]
  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 ]
  6. Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) [ Time Frame: 6 hrs after the completion of the therapeutic thoracentesis ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192138


Contacts
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Contact: Rafal M Krenke, MD, PhD +48225992562 rafalkrenke@interia.pl
Contact: Piotr Korczynski, MD, PhD +48225992562 drkorczynski@gmail.com

Locations
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Poland
Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Rafal M Krenke, MD, PhD    +48225992562    rafalkrenke@interia.pl   
Contact: Piotr Korczynski, MD, PhD    +48225992562    drkorczynski@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Rafal M Krenke, MD, PhD Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02192138     History of Changes
Other Study ID Numbers: IPU-DIMPA-WUM14(1)
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by Medical University of Warsaw:
Pleural effusion
Pleural fluid
Thoracentesis
Intrapleural pressure
Pleural manometry

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases