Pleural Manometry in Thoracocentesis

Sponsor
Aly Sherif Hassaballa (Other)
Overall Status
Completed
CT.gov ID
NCT04420663
Collaborator
(none)
110
1
2
30
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pleural Manometry
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University Cairo Egypt

Sponsors and Collaborators

  • Aly Sherif Hassaballa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aly Sherif Hassaballa, Clinical Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04420663
Other Study ID Numbers:
  • ASHassaballaMD
First Posted:
Jun 9, 2020
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022