NCT02192138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

4.4 years

First QC Date

July 1, 2014

Last Update Submit

November 16, 2020

Conditions

Pleural EffusionExudative Pleuritis

Keywords

Pleural effusionPleural fluidThoracentesisIntrapleural pressurePleural manometry

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Volume of withdrawn pleural fluid

    Continuous measurement during therapeutic thoracentesis - up to 60 minutes

Other Outcomes (6)

  • Change in arterial blood gases and transcutaneous carbon dioxide tension (tcPCO2) and transcutaneous oxygen tension (tcPO2) measurements

    Continuous measurement during therapeutic thoracentesis - up to 60 minutes

  • Respiratory pattern including respiratory rate and tidal volume

    Continuous measurement during therapeutic thoracentesis - up to 60 minutes

  • Change in lung function

    Baseline (approximately 1 hour before thoracentesis) and 6 hrs after therapeutic thoracentesis

  • +3 more other outcomes

Study Arms (1)

Therapeutic thoracentesis

EXPERIMENTAL

Patients with pleural effusion who require therapeutic thoracentesis will be enrolled into the study

Procedure: Therapeutic thoracentesisDevice: Pleural catheterDevice: Pleural manometer

Interventions

Therapeutic thoracentesisPROCEDURE

Therapeutic thoracentesis with pleural fluid withdrawal

Therapeutic thoracentesis
Pleural catheterDEVICE
Therapeutic thoracentesis
Pleural manometerDEVICE
Therapeutic thoracentesis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • poor performance status requiring maximal shortening of the procedure,
  • instable hemodynamic or respiratory status unrelated to pleural effusion,
  • respiratory failure requiring mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Related Publications (2)

  • 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.

    PMID: 29444649DERIVED

  • 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.

    PMID: 25367064DERIVED

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Rafal M Krenke, MD, PhD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 16, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

PL(1)