Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
Primary Purpose
Pleural Effusion, Exudative Pleuritis
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Therapeutic thoracentesis
Pleural catheter
Pleural manometer
Sponsored by
About this trial
This is an interventional basic science trial for Pleural Effusion focused on measuring Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry
Eligibility Criteria
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.
Sites / Locations
- Medical University of Warsaw
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic thoracentesis
Arm Description
Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study
Outcomes
Primary Outcome Measures
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),
Intrapleural pressure
Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
Secondary Outcome Measures
Volume of withdrawn pleural fluid
Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes
Full Information
NCT ID
NCT02192138
First Posted
July 1, 2014
Last Updated
November 16, 2020
Sponsor
Medical University of Warsaw
Collaborators
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02192138
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Exudative Pleuritis
Keywords
Pleural effusion, Pleural fluid, Thoracentesis, Intrapleural pressure, Pleural manometry
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic thoracentesis
Arm Type
Experimental
Arm Description
Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study
Intervention Type
Procedure
Intervention Name(s)
Therapeutic thoracentesis
Intervention Description
Therapeutic thoracentesis with pleural fluid withdrawal
Intervention Type
Device
Intervention Name(s)
Pleural catheter
Intervention Type
Device
Intervention Name(s)
Pleural manometer
Primary Outcome Measure Information:
Title
Change in intrapleural pressure
Description
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),
Time Frame
Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
Title
Intrapleural pressure
Description
Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.
Time Frame
6 hrs after completion of therapeutic thoracentesis
Secondary Outcome Measure Information:
Title
Volume of withdrawn pleural fluid
Description
Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes
Time Frame
Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Other Pre-specified Outcome Measures:
Title
Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
Description
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),
Time Frame
Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Title
Respiratory pattern including respiratory rate and tidal volume
Description
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),
Time Frame
Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Title
Change in lung function
Description
Lung function parameters measured by spirometry and body plethysmography
Time Frame
Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
Title
Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
Description
Venous blood samples were collected for natriuretic peptides measurements.
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)
Title
Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements
Description
Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system.
Time Frame
6 hrs after the completion of therapeutic thoracentesis
Title
Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)
Description
Venous blood samples were collected for natriuretic peptides measurements.
Time Frame
6 hrs after the completion of the therapeutic thoracentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal M Krenke, MD, PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29444649
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.
Results Reference
derived
PubMed Identifier
25367064
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.
Results Reference
derived
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Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
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