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Vacuum vs Manual Drainage During Unilateral Thoracentesis

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ClinicalTrials.gov Identifier: NCT03496987
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : August 31, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Pleural Diseases Thoracic Diseases Device: Vacuum Bottle Drainage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : March 1, 2018

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 Name: Evacuated Cylinder




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496987


Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jonathan T Puchalski, MD, MEd Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol  [PDF] November 17, 2015
Statistical Analysis Plan  [PDF] March 2, 2018
Informed Consent Form  [PDF] November 18, 2015


Publications:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03496987     History of Changes
Other Study ID Numbers: 1511016858
P30AG021342 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Pleural Effusion
Pleural Drainage
Thoracentesis

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Thoracic Diseases
Respiratory Tract Diseases