Pleural Manometry in Thoracocentesis

Thoracocentesis of Pleural Effusion Clinical Trial

Official title:

Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420663
• Other study ID #: ASHassaballaMD
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Description:

This prospective controlled trial study will be performed between July 2019 and December 2020. the investigators will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.

The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 85 years,

2. pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)

3. no contraindications for therapeutic thoracentesis

4. general health condition allowing prolonged procedure of therapeutic thoracentesis.

Exclusion Criteria:

• patients with very small amounts of pleural effusion

• patients on mechanical ventilation

• patients using anticoagulant therapy

• patients refusing to be subjected to thoracocentesis.

Related Conditions & MeSH terms

• Pleural Effusion
• Thoracocentesis of Pleural Effusion

Intervention

Diagnostic Test:
• Pleural Manometry
Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.

Locations

Country	Name	City	State
Egypt	Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Aly Sherif Hassaballa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pleural pressure	To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer	Continous monitoring during the whole session of thoracocentesis