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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG021342 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum Bottle Drainage | Device | Patients undergo drainage via vacuum bottles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Drainage | Actual time of drainage in seconds for each patient. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan T Puchalski, MD, MEd | Yale University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23952852 | Background | 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. | |
| 12576360 | 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. |
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Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Drainage | Patients undergo drainage of pleural fluid via manual (syringe) system |
| FG001 | Vacuum Bottle Drainage | Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Drainage | Patients undergo drainage of pleural fluid via manual (syringe) system |
| BG001 | Vacuum Bottle Drainage | Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication). | Posted | Mean | Standard Deviation | Pre-post NPRS Pain Scale Score | 5-20 minutes |
|
1 month following procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Drainage | Patients undergo drainage of pleural fluid via manual (syringe) system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Pneumothorax | Systematic Assessment | Pneumothorax as a result of the procedure |
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This was a single center study with a modest patient size. There was heterogeneity between the two arms of the study which limits interpretation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Puchalski, MD | Yale University School of Medicine | 2037375699 | jonathan.puchalski@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2015 | Jun 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2018 | Jun 27, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2015 | Jun 27, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.
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| 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) | <7 days |
| Etiology of Effusion | Clinical etiology of effusion | <7 days |
| Volume of Effusion | Volume of effusion drained (in mL) | <20 minutes |
| Laterality of Effusion | Laterality of effusion (left or right) | <20 minutes |
| 20696688 | 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. |
| 3522123 | 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. |
| 1929699 | 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. |
| 2017951 | 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. |
| 17035453 | 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. |
| 19052935 | 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. |
| 16778274 | 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. |
| 14861005 | 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. |
| 13212859 | 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. |
| 23219348 | 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. |
| 10767236 | 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. |
| 27315094 | 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. |
| 28638284 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergo drainage of pleural fluid via manual (syringe) system
| OG001 | Vacuum Bottle Drainage | Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles |
|
|
| Secondary | Time of Drainage | Actual time of drainage in seconds for each patient. | 1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication). | Posted | Mean | Standard Deviation | seconds | 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). | Posted | Count of Participants | Participants | 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) | 1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication). | Posted | Count of Participants | Participants | <7 days |
|
|
|
| Secondary | Etiology of Effusion | Clinical etiology of effusion | 1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication). | Posted | Count of Participants | Participants | <7 days |
|
|
|
| Secondary | Volume of Effusion | Volume of effusion drained (in mL) | 1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication). | Posted | Mean | Standard Deviation | milliters | <20 minutes |
|
|
|
| Secondary | Laterality of Effusion | Laterality of effusion (left or right) | Posted | Count of Participants | Participants | <20 minutes |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Vacuum Bottle Drainage | Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder) Vacuum Bottle Drainage: Patients undergo drainage via vacuum bottles | 0 | 51 | 5 | 51 | 0 | 51 |
|
| Clinically Significant Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Pulmonary Edema | Systematic Assessment | Clinically Significant Pulmonary Edema requiring ventilatory support |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Hemothorax | Systematic Assessment | Hemothorax (or bleeding in the thoracic cavity as a result of the procedure) |
|
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| Clinically Significant Pulmonary Edema |
|
| Heart Failure |
|
| Hepatic Hydrothorax |
|
| Post-Cardiothoracic Procedure |
|
| Parapneumonic |
|
| Unknown |
|