Vacuum vs Manual Drainage During Unilateral Thoracentesis

July 12, 2023 updated by: Yale University

Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Evacuated Cylinder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5-20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Drainage
Time Frame: 5-20 minutes
Actual time of drainage in seconds for each patient.
5-20 minutes
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).
5-20 minutes
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)
<7 days
Etiology of Effusion
Time Frame: <7 days
Clinical etiology of effusion
<7 days
Volume of Effusion
Time Frame: <20 minutes
Volume of effusion drained (in mL)
<20 minutes
Laterality of Effusion
Time Frame: <20 minutes
Laterality of effusion (left or right)
<20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jonathan T Puchalski, MD, MEd, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1511016858
  • P30AG021342 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pleural Diseases

Clinical Trials on Vacuum Bottle Drainage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe