Vacuum vs Manual Drainage During Unilateral Thoracentesis
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|ClinicalTrials.gov Identifier: NCT03496987|
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : August 31, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion Pleural Diseases Thoracic Diseases||Device: Vacuum Bottle Drainage||Not Applicable|
Patients with pleural effusions routinely undergo thoracentesis in which a catheter is placed into the pleural space to remove the fluid both for diagnostic and therapeutic reasons. In this setting, large amounts (often liters) of fluid are removed to palliate the patient's symptoms of breathlessness.
Thoracentesis is the most commonly performed and least invasive method to remove pleural fluid. These frequently performed using a catheter drainage system where a small, flexible temporary catheter is inserted over a needle into the pleural cavity. After insertion of catheter into the pleural space, the operator has two drainage system options: 1. Manual drainage via syringe-pump that connects to drainage bag or 2. Drainage into a vacuum bottle. Both are routinely performed in almost every hospital in the United States.
Pleural pressure (Ppl) is determined by the elastic recoil properties of the lung and chest wall. Normal pleural pressure is estimated to be -3 to -5 cm H20 at functional residual capacity. During drainage of pleural fluid, negative pressure is applied either via syringe during manual drainage or via vacuum using vacuum drainage bottle. Hypothetically more negative pressure can translate to increased perception of pain or visceral pleural injury.
Two techniques (manual vs vacuum drainage) are used based on the operator preference and both are standard of care. To our knowledge there is no head to head comparison of these two available systems of drainages during thoracentesis of pleural effusions. Knowing if one is superior to the other will aid future clinicians.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.|
|Masking:||None (Open Label)|
|Official Title:||Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||March 1, 2018|
No Intervention: Manual Drainage
Patients undergo drainage of pleural fluid via manual (syringe) system
Experimental: Vacuum Bottle Drainage
Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)
Device: Vacuum Bottle Drainage
Patients undergo drainage via vacuum bottles
Other Name: Evacuated Cylinder
- Pain Change [ Time Frame: 5-20 minutes ]
Difference in pain between pre-procedural pain and during drainage pain as measured as the difference between a pre-procedural NPSS pain score (range from 0 (no pain) to 10 (maximum pain)). This was asked again during drainage and the difference between the two was recorded. The values ranged from -10 to 10 (with a more negative number representing a decrease in pain and a more positive number representing an increase in pain)
The scale used is called The Numeric Pain Rating Scale. With ratings from 0-10. Zero is the least amount of pain experienced while 10 is the worst pain possible.
- Time of Drainage [ Time Frame: 5-20 minutes ]Actual time of drainage in seconds for each patient.
- Number of Patients Who Had an Early Termination of Procedure [ Time Frame: 5-20 minutes ]Patients who had procedure termination prior to complete evacuation of the pleural contents (usually as a result of refractory pain or another symptom that the patient perceived).
- Number of Patients Who Had a Complication as a Result of the Procedure [ Time Frame: <7 days ]Any complications that occur as a direct result of the procedure. We tracked patients for 7 days after the procedure to capture any complications (which is typical clinical practice)
- Etiology of Effusion [ Time Frame: <7 days ]Clinical etiology of effusion
- Volume of Effusion [ Time Frame: <20 minutes ]Volume of effusion drained (in mL)
- Laterality of Effusion [ Time Frame: <20 minutes ]Laterality of effusion (left or right)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496987
|Principal Investigator:||Jonathan T Puchalski, MD, MEd||Yale University|