Vacuum vs Manual Drainage During Unilateral Thoracentesis

Not Applicable

Completed

• Conditions: Pleural Effusion; Pleural Diseases; Thoracic Diseases
• Interventions: Device: Vacuum Bottle Drainage

• Registration Number: NCT03496987
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-03-01
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Results First Submitted: 2018-04-13
• Results First Submitted QC: 2018-07-31
• Results First Posted: 2018-08-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing unilateral therapeutic thoracentesis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum Bottle Drainage	Vacuum Bottle Drainage	Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Primary Outcome Measures

Name	Time	Method
Pain Change	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.

Secondary Outcome Measures

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