Vacuum vs Manual Drainage During Unilateral Thoracentesis

Study Overview
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Brief Summary
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The purpose of this study is to determine if there are any differences in terms of safety, pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.

Detailed Description
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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.

Official Title
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Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial

Conditions
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Pleural Effusion, Pleural Diseases, Thoracic Diseases

Intervention / Treatment
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* Device: Vacuum Bottle Drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral therapeutic thoracentesis Exclusion Criteria: Patients with a history of prior significant pleural or lung based procedures/surgeries (not a simple thoracentesis) Prior enrollment in this study Patients ability to comprehend and consent to this procedure and clearly communicate any pain or other symptoms that arise from this procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Manual Drainage<br>Patients undergo drainage of pleural fluid via manual (syringe) system | |
| Experimental: Vacuum Bottle Drainage<br>Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) | Device: Vacuum Bottle Drainage<br>* Patients undergo drainage via vacuum bottles<br>* Other names: Evacuated Cylinder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Change | 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. | 5-20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Drainage | Actual time of drainage in seconds for each patient. | 5-20 minutes | 
| Number of Patients Who Had an Early Termination of Procedure | 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). | 5-20 minutes | 
| Number of Patients Who Had a Complication as a Result of the Procedure | 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) | <7 days | 
| Etiology of Effusion | Clinical etiology of effusion | <7 days | 
| Volume of Effusion | Volume of effusion drained (in mL) | <20 minutes | 
| Laterality of Effusion | Laterality of effusion (left or right) | <20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural Effusion, Pleural Drainage, Thoracentesis