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
About this trial
This is an interventional treatment trial for Pleural Effusion focused on measuring Pleural Effusion, Pleural Drainage, Thoracentesis
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
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
NCT ID
NCT03496987
First Posted
April 4, 2018
Last Updated
July 12, 2023
Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)
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
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Vacuum vs Manual Drainage During Unilateral Thoracentesis
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