Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

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

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Exudative Pleuritis
• Intervention / Treatment: Procedure: Therapeutic thoracentesis; Device: Pleural catheter; Device: Pleural manometer

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
Intrapleural pressure	Pleural manometer was connected to intrapleural catheter for intrapleural pressure measurement after therapeutic thoracetnesis.	6 hrs after completion of therapeutic thoracentesis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of withdrawn pleural fluid	Continuous measurement during pleural fluid withdrawal, up to the end of the procedure, i.e. approximately 60 minutes	Continuous measurement during therapeutic thoracentesis - up to 60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements	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),	Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Respiratory pattern including respiratory rate and tidal volume	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),	Continuous measurement during therapeutic thoracentesis - up to 60 minutes
Change in lung function	Lung function parameters measured by spirometry and body plethysmography	Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
Change in atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)	Venous blood samples were collected for natriuretic peptides measurements.	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)
Arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements	Transcutaneous PO2 and PCO2 were measured in accordance with the manual supplied by the manufacturer of the transcutaneous O2/CO2 monitoring system.	6 hrs after the completion of therapeutic thoracentesis
Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP)	Venous blood samples were collected for natriuretic peptides measurements.	6 hrs after the completion of the therapeutic thoracentesis

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
• Investigators: Principal Investigator: Rafal M Krenke, MD, PhD, Medical University of Warsaw

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pleural effusion; Thoracentesis; Pleural fluid; Intrapleural pressure; Pleural manometry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: IPU-DIMPA-WUM14(1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No