Pleural Manometry in Thoracocentesis

Not Applicable

Completed

• Conditions: Thoracocentesis of Pleural Effusion

• Registration Number: NCT04420663
• Lead Sponsor: Aly Sherif Hassaballa

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the pleural pressure	Continous monitoring during the whole session of thoracocentesis	To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer

Trial Locations

Locations (1)

Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt