Pleural EffusionNCT03496987
Vacuum vs Manual Drainage During Unilateral Thoracentesis
A study testing Vacuum Bottle Drainage in people with Pleural Effusion and Pleural Diseases, run by Yale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pleural Effusion, Pleural Diseases, Thoracic Diseases
- What is being tested?
- Vacuum Bottle Drainage
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral therapeutic thoracentesis
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusion, Pleural Diseases, Thoracic Diseases
- Being tested
- Vacuum Bottle Drainage
- Keywords
- Pleural Effusion, Pleural Drainage, Thoracentesis
- Medical subject headings
- Pleural Effusion, Pleural Diseases, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Bottle DrainageDevice
Also called Evacuated Cylinder
Patients undergo drainage via vacuum bottles
| Study group | Role | What they receive |
|---|---|---|
| Manual Drainage | No intervention | Patients undergo drainage of pleural fluid via manual (syringe) system |
| Vacuum Bottle Drainage | Experimental | Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Receives: Device: Vacuum Bottle Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-20 minutes
Secondary outcomes (6)
Time of Drainage
Actual time of drainage in seconds for each patient.
Measured: 5-20 minutes
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).
Measured: 5-20 minutes
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)
Measured: <7 days
Etiology of Effusion
Clinical etiology of effusion
Measured: <7 days
Volume of Effusion
Volume of effusion drained (in mL)
Measured: <20 minutes
Laterality of Effusion
Laterality of effusion (left or right)
Measured: <20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Dec 2015
- Primary completion30 Sep 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jonathan T Puchalski, MD, MEd, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496987
- Sponsor's protocol ID
- 1511016858
- Other IDs
- P30AG021342
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2018
- Last updated
- 14 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23952852Jones 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.
PubMed 12576360Havelock 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.
PubMed 20696688Seneff 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.
PubMed 3522123Roth 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.
PubMed 1929699Raptopoulos 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.
PubMed 2017951Heidecker 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.
PubMed 17035453Josephson 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.
PubMed 19052935Feller-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.
PubMed 16778274BEECH 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.
PubMed 14861005ALBERTSON 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.
PubMed 13212859Puchalski 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.
PubMed 23219348Petersen WG, Zimmerman R. Limited utility of chest radiograph after thoracentesis. Chest. 2000 Apr;117(4):1038-42. doi: 10.1378/chest.117.4.1038.
PubMed 10767236Kelil 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.
PubMed 27315094Alraiyes 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.
PubMed 28638284
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03496987
- Acronym / sponsor ID
- 1511016858
- Conditions
- Pleural Effusion, Pleural Diseases, Thoracic Diseases
- Keywords
- Pleural Effusion, Pleural Drainage, Thoracentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.
| Arm | Type | Receives |
|---|---|---|
| Manual Drainage | No intervention | –Patients undergo drainage of pleural fluid via manual (syringe) system |
| Vacuum Bottle Drainage | Experimental | Device: Vacuum Bottle DrainagePatients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing unilateral therapeutic thoracentesis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum Bottle DrainageAlso: Evacuated CylinderPatients undergo drainage via vacuum bottles | Device | Vacuum Bottle Drainage |
Primary outcome
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.
6 secondary outcomes
Time of Drainage
Time frame: 5-20 minutes
Number of Patients Who Had an Early Termination of Procedure
Time frame: 5-20 minutes
Number of Patients Who Had a Complication as a Result of the Procedure
Time frame: <7 days
Etiology of Effusion
Time frame: <7 days
Volume of Effusion
Time frame: <20 minutes
Laterality of Effusion
Time frame: <20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23952852Puchalski 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.
- Background: PubMed 12576360Jones 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.
- Background: PubMed 20696688Havelock 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.
- Background: PubMed 3522123Seneff 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.
- Background: PubMed 1929699Roth 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.
- Background: PubMed 2017951Raptopoulos 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.
- Background: PubMed 17035453Heidecker 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.
- Background: PubMed 19052935Josephson 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.
- Background: PubMed 16778274Feller-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.
- Background: PubMed 14861005BEECH 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.
- Background: PubMed 13212859ALBERTSON 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.
- Background: PubMed 23219348Puchalski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan T Puchalski, MD, MEd principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Bottle Drainage in people with Pleural Effusion and Pleural Diseases, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change (time frame: 5-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496987, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.