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Vacuum vs Manual Drainage During Unilateral Thoracentesis

Primary Purpose

Pleural Effusion, Pleural Diseases, Thoracic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vacuum Bottle Drainage
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Pleural Effusion, Pleural Drainage, Thoracentesis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Manual Drainage

    Vacuum Bottle Drainage

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Pain Change
    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

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

    Full Information

    First Posted
    April 4, 2018
    Last Updated
    July 12, 2023
    Sponsor
    Yale University
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03496987
    Brief Title
    Vacuum vs Manual Drainage During Unilateral Thoracentesis
    Official Title
    Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion, Pleural Diseases, Thoracic Diseases
    Keywords
    Pleural Effusion, Pleural Drainage, Thoracentesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual Drainage
    Arm Type
    No Intervention
    Arm Description
    Patients undergo drainage of pleural fluid via manual (syringe) system
    Arm Title
    Vacuum Bottle Drainage
    Arm Type
    Experimental
    Arm Description
    Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)
    Intervention Type
    Device
    Intervention Name(s)
    Vacuum Bottle Drainage
    Other Intervention Name(s)
    Evacuated Cylinder
    Intervention Description
    Patients undergo drainage via vacuum bottles
    Primary Outcome Measure Information:
    Title
    Pain Change
    Description
    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.
    Time Frame
    5-20 minutes
    Secondary Outcome Measure Information:
    Title
    Time of Drainage
    Description
    Actual time of drainage in seconds for each patient.
    Time Frame
    5-20 minutes
    Title
    Number of Patients Who Had an Early Termination of Procedure
    Description
    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).
    Time Frame
    5-20 minutes
    Title
    Number of Patients Who Had a Complication as a Result of the Procedure
    Description
    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 Frame
    <7 days
    Title
    Etiology of Effusion
    Description
    Clinical etiology of effusion
    Time Frame
    <7 days
    Title
    Volume of Effusion
    Description
    Volume of effusion drained (in mL)
    Time Frame
    <20 minutes
    Title
    Laterality of Effusion
    Description
    Laterality of effusion (left or right)
    Time Frame
    <20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan T Puchalski, MD, MEd
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23952852
    Citation
    Puchalski JT, Argento AC, Murphy TE, Araujo KL, Pisani MA. The safety of thoracentesis in patients with uncorrected bleeding risk. Ann Am Thorac Soc. 2013 Aug;10(4):336-41. doi: 10.1513/AnnalsATS.201210-088OC.
    Results Reference
    background
    PubMed Identifier
    12576360
    Citation
    Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23. doi: 10.1378/chest.123.2.418.
    Results Reference
    background
    PubMed Identifier
    20696688
    Citation
    Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
    Results Reference
    background
    PubMed Identifier
    3522123
    Citation
    Seneff MG, Corwin RW, Gold LH, Irwin RS. Complications associated with thoracocentesis. Chest. 1986 Jul;90(1):97-100. doi: 10.1378/chest.90.1.97.
    Results Reference
    background
    PubMed Identifier
    1929699
    Citation
    Roth BJ, Cragun WH, Grathwohl KW. Complications associated with thoracentesis. Arch Intern Med. 1991 Oct;151(10):2095-6. doi: 10.1001/archinte.151.10.2095a. No abstract available.
    Results Reference
    background
    PubMed Identifier
    2017951
    Citation
    Raptopoulos V, Davis LM, Lee G, Umali C, Lew R, Irwin RS. Factors affecting the development of pneumothorax associated with thoracentesis. AJR Am J Roentgenol. 1991 May;156(5):917-20. doi: 10.2214/ajr.156.5.2017951.
    Results Reference
    background
    PubMed Identifier
    17035453
    Citation
    Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest. 2006 Oct;130(4):1173-84. doi: 10.1378/chest.130.4.1173.
    Results Reference
    background
    PubMed Identifier
    19052935
    Citation
    Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol. 2009 Jan;50(1):42-7. doi: 10.1080/02841850802590460.
    Results Reference
    background
    PubMed Identifier
    16778274
    Citation
    Feller-Kopman D, Walkey A, Berkowitz D, Ernst A. The relationship of pleural pressure to symptom development during therapeutic thoracentesis. Chest. 2006 Jun;129(6):1556-60. doi: 10.1378/chest.129.6.1556.
    Results Reference
    background
    PubMed Identifier
    14861005
    Citation
    BEECH RD. Practical system for thoracentesis using the blood donor set. J Am Med Assoc. 1951 Aug 25;146(17):1597. doi: 10.1001/jama.1951.63670170006011d. No abstract available.
    Results Reference
    background
    PubMed Identifier
    13212859
    Citation
    ALBERTSON HA, LEAVITT D, GAMBLE JR. A simple method for doing a thoracentesis using a plasma-collecting vacuum bottle. J Thorac Surg. 1954 Nov;28(5):544-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23219348
    Citation
    Puchalski JT, Argento AC, Murphy TE, Araujo KL, Oliva IB, Rubinowitz AN, Pisani MA. Etiologies of bilateral pleural effusions. Respir Med. 2013 Feb;107(2):284-91. doi: 10.1016/j.rmed.2012.10.004. Epub 2012 Dec 7.
    Results Reference
    background
    PubMed Identifier
    10767236
    Citation
    Petersen WG, Zimmerman R. Limited utility of chest radiograph after thoracentesis. Chest. 2000 Apr;117(4):1038-42. doi: 10.1378/chest.117.4.1038.
    Results Reference
    background
    PubMed Identifier
    27315094
    Citation
    Kelil T, Shyn PB, Wu LE, Levesque VM, Kacher D, Khorasani R, Silverman SG. Wall suction-assisted image-guided therapeutic paracentesis: a safe and less expensive alternative to evacuated bottles. Abdom Radiol (NY). 2016 Jul;41(7):1333-7. doi: 10.1007/s00261-016-0634-x.
    Results Reference
    background
    PubMed Identifier
    28638284
    Citation
    Alraiyes AH, Kheir F, Harris K, Gildea TR. How Much Negative Pressure Are We Generating During Thoracentesis? Ochsner J. 2017 Summer;17(2):138-140. No abstract available.
    Results Reference
    background

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    Vacuum vs Manual Drainage During Unilateral Thoracentesis

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