Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

November 16, 2020 updated by: Medical University of Warsaw

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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),
Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes
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.
6 hrs after completion of therapeutic thoracentesis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Continuous measurement during therapeutic thoracentesis - up to 60 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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),
Continuous measurement during therapeutic thoracentesis - up to 60 minutes
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),
Continuous measurement during therapeutic thoracentesis - up to 60 minutes
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
Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis
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.
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
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 hrs after the completion of therapeutic thoracentesis
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.
6 hrs after the completion of the therapeutic thoracentesis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rafal M Krenke, MD, PhD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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