Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02192138
• Date of registration: 01/07/2014
• Prospective Registration: Yes
• Primary sponsor: Medical University of Warsaw
• Public title: Pathophysiological Effects of Intrapleural Pressure Changes During Therapeutic Thoracentesis
• Scientific title: Ventilation, Gas Exchange and Cardiac Function in Relation to Intrapleural Pressure Changes in Patients Undergoing Therapeutic Thoracentesis
• Date of first enrolment: August 2014
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02192138
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Rafal M Krenke, MD, PhD
• Affiliation: Medical University of Warsaw

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Exudative Pleuritis

Pleural Effusion

Intervention(s)

Device: Pleural manometer

Device: Pleural catheter

Procedure: Therapeutic thoracentesis

Primary Outcome(s)

Change in intrapleural pressure [Time Frame: Continuous measurement as a function of withdrawn pleural fluid during therapeutic thoracentesis - up to 60 minutes]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]

Secondary Outcome(s)

Volume of withdrawn pleural fluid [Time Frame: Continuous measurement during therapeutic thoracentesis - up to 60 minutes]

Secondary ID(s)

IPU-DIMPA-WUM14(1)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences