Vacuum vs Manual Drainage During Unilateral Thoracentesis

Pleural Effusion Clinical Trial

Official title:

Vacuum vs Manual Drainage During Unilateral Thoracentesis: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496987
• Other study ID #: 1511016858
• Secondary ID: P30AG021342
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: March 1, 2018

Study information

• Verified date: July 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Diseases
• Pleural Effusion
• Thoracic Diseases

Intervention

Device:
• Vacuum Bottle Drainage
Patients undergo drainage via vacuum bottles

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5-20 minutes
Secondary	Time of Drainage	Actual time of drainage in seconds for each patient.	5-20 minutes
Secondary	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).	5-20 minutes
Secondary	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)	<7 days
Secondary	Etiology of Effusion	Clinical etiology of effusion	<7 days
Secondary	Volume of Effusion	Volume of effusion drained (in mL)	<20 minutes
Secondary	Laterality of Effusion	Laterality of effusion (left or right)	<20 minutes