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Completed

NCT Number: NCT03496987

Vacuum vs Manual Drainage During Unilateral Thoracentesis

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases Thoracic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vacuum Bottle Drainage

Device

Patients undergo drainage via vacuum bottles

Other names: Evacuated Cylinder

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time of Drainage

    Time frame: 5-20 minutes

    Actual time of drainage in seconds for each patient.

  2. 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).

  3. 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)

  4. Etiology of Effusion

    Time frame: <7 days

    Clinical etiology of effusion

  5. Volume of Effusion

    Time frame: <20 minutes

    Volume of effusion drained (in mL)

  6. Laterality of Effusion

    Time frame: <20 minutes

    Laterality of effusion (left or right)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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