Vacuum vs Manual Drainage During Unilateral Thoracentesis

Yale University

Status: Completed

Conditions: Pleural Effusion; Pleural Diseases; Thoracic Diseases

Treatments: Device: Vacuum Bottle Drainage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03496987

P30AG021342 (U.S. NIH Grant/Contract)

1511016858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Manual Drainage

No Intervention group

Description:

Patients undergo drainage of pleural fluid via manual (syringe) system

Vacuum Bottle Drainage

Experimental group

Description:

Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)

Treatment:

Device: Vacuum Bottle Drainage