Back to resultsPleural Manometry in Thoracocentesis
Primary Purpose
Thoracocentesis of Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pleural Manometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Thoracocentesis of Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
- Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Manometer Group
Conventional Group
Arm Description
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.
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 Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between.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.
Outcomes
Primary Outcome Measures
the pleural pressure
To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04420663
Brief Title
Pleural Manometry in Thoracocentesis
Official Title
Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aly Sherif Hassaballa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracocentesis of Pleural Effusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manometer Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pleural Manometry
Intervention Description
Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
Primary Outcome Measure Information:
Title
the pleural pressure
Description
To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer
Time Frame
Continous monitoring during the whole session of thoracocentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Facility Information:
Facility Name
Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pleural Manometry in Thoracocentesis
We'll reach out to this number within 24 hrs