Pleural Manometry in Thoracocentesis

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

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 Overview

• Status: Completed
• Conditions: Thoracocentesis of Pleural Effusion
• Intervention / Treatment: Diagnostic test: Pleural Manometry

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manometer Group; Therapeutic thoracentesis will be performed in a sitting position. wide bore catheter as a pleural catheter will be inserted into the pleural cavity. simple water manometer will be connected to the pleural catheter via 3-way adapter.connected to the infusion lines with one draining into the drainage collection bottle and the other pre-flushed with normal saline hanging down till 40 cm below the puncture site and then rising up (forming a "U") with the ascending arm taped to the IV stand. baseline pleural pressure will be registered before the beginning of pleural fluid withdrawal. Pleural pressure curve will subsequently be registered after the withdrawal of each 200 ml of pleural fluid up to a total volume of 1000 ml.	Diagnostic test: Pleural Manometry; Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
No Intervention: Conventional Group; Therapeutic thoracentesis will be performed in a sitting position. The skin will be cleaned with betadine antiseptic solution. Pleural aspiration should take place in a clean area using full aseptic techniques. 5-10 cc Lidocaine 2% will be given as local anesthetic in the site of puncture. the IV cannula is advanced till fluid is aspirated. Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between. connected to the infusion lines with one draining into the drainage collection bottle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aly Sherif Hassaballa

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: ASHassaballaMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No