Vacuum vs Manual Drainage During Unilateral Thoracentesis

NCT03496987 | Completed Results

• 2 other identifiers: 1511016858P30AG021342
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pleural Effusion; Pleural Diseases; Thoracic Diseases

Keywords

Pleural Effusion; Pleural Drainage; Thoracentesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time of Drainage

  5-20 minutes

• Number of Patients Who Had an Early Termination of Procedure

  5-20 minutes

• Number of Patients Who Had a Complication as a Result of the Procedure

  <7 days

• Etiology of Effusion

  <7 days

• Volume of Effusion

  <20 minutes

Study Arms (2)

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)

Device: Vacuum Bottle Drainage

Interventions

Vacuum Bottle Drainage DEVICE

Patients undergo drainage via vacuum bottles

Also known as: Evacuated Cylinder

Vacuum Bottle Drainage

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral therapeutic thoracentesis

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator

Related Publications (15)

• 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.

  PMID: 23952852 BACKGROUND

• 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.

  PMID: 12576360 BACKGROUND

• 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.

  PMID: 20696688 BACKGROUND

• 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.

  PMID: 3522123 BACKGROUND

• 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.

  PMID: 1929699 BACKGROUND

• 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.

  PMID: 2017951 BACKGROUND

• 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.

  PMID: 17035453 BACKGROUND

• 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.

  PMID: 19052935 BACKGROUND

• 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.

  PMID: 16778274 BACKGROUND

• 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.

  PMID: 14861005 BACKGROUND

• 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.

  PMID: 13212859 BACKGROUND

• 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.

  PMID: 23219348 BACKGROUND

• 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.

  PMID: 10767236 BACKGROUND

• 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.

  PMID: 27315094 BACKGROUND

• 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.

  PMID: 28638284 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Pleural Diseases; Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Limitations and Caveats

This was a single center study with a modest patient size. There was heterogeneity between the two arms of the study which limits interpretation.

Results Point of Contact

• Title: Jonathan Puchalski, MD
• Organization: Yale University School of Medicine

jonathan.puchalski@yale.edu

2037375699

Study Officials

• Jonathan T Puchalski, MD, MEd

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 12, 2018
• Study Start: December 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: March 1, 2018
• Last Updated: July 14, 2023
• Results First Posted: August 31, 2018

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share