Pleural Manometry in Thoracocentesis

NCT04420663 | Completed

• 1 other identifier: ASHassaballaMD
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracocentesis of Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Manometer Group

EXPERIMENTAL

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

Conventional Group

NO INTERVENTION

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 Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between.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.

Interventions

Pleural Manometry DIAGNOSTIC_TEST

Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.

Manometer Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 85 years,
• pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)
• no contraindications for therapeutic thoracentesis
• general health condition allowing prolonged procedure of therapeutic thoracentesis.

You may not qualify if:

• patients with very small amounts of pleural effusion
• patients on mechanical ventilation
• patients using anticoagulant therapy
• patients refusing to be subjected to thoracocentesis.

Sponsors & Collaborators

• Aly Sherif Hassaballa: lead

Study Sites (1)

Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Hassaballa AS, Mostafa A, Hikal T, Elnori A, Elsayed HH. Pleural manometry during thoracocentesis in patients with malignant pleural effusion: A randomized controlled trial. Can J Respir Ther. 2023 Jan 20;59:33-44. doi: 10.29390/cjrt-2022-047. eCollection 2023.

  PMID: 36741303 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This prospective controlled trial study will be performed between August 2019 and August 2020. We 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.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)