An interventional study of Vacuum Bottle Drainage in Pleural Effusion, Pleural Diseases and Thoracic Diseases, sponsored by Yale University. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergo drainage of pleural fluid via manual (syringe) system
Patients undergo drainage of pleural fluid via a vacuum bottle system (evacuated cylinder)
Device: Vacuum Bottle Drainage
Patients undergo drainage via vacuum bottles
Also known as: Evacuated Cylinder
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.
Time frame: 5-20 minutes
Time of Drainage
Actual time of drainage in seconds for each patient.
Time frame: 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).
Time frame: 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)
Time frame: <7 days
Etiology of Effusion
Clinical etiology of effusion
Time frame: <7 days
Volume of Effusion
Volume of effusion drained (in mL)
Time frame: <20 minutes
Laterality of Effusion
Laterality of effusion (left or right)
Time frame: <20 minutes
Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis
| Milestone | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Started | 49 | 51 |
| Completed | 49 | 51 |
| Not completed | 0 | 0 |
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.
| Pre-post NPRS Pain Scale Score | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Pain Change | 0.53 ± 1.7 | 1.43 ± 2.7 |
Actual time of drainage in seconds for each patient.
| seconds | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Time of Drainage | 498.5 ± 386.5 | 318.6 ± 193 |
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).
| Participants | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Number of Patients Who Had an Early Termination of Procedure | 1 | 8 |
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)
| Participants | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Pneumothorax | 0 | 3 |
| Hemothorax | 0 | 1 |
| Clinically Significant Pulmonary Edema | 0 | 1 |
Clinical etiology of effusion
| Participants | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Malignant | 13 | 8 |
| Paramalignant | 7 | 2 |
| Heart Failure | 7 | 8 |
| Hepatic Hydrothorax | 3 | 5 |
| Post-Cardiothoracic Procedure | 13 | 17 |
| Parapneumonic | 3 | 2 |
| Unknown | 3 | 8 |
Volume of effusion drained (in mL)
| milliters | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Volume of Effusion | 1023 ± 674 | 1143 ± 775 |
Laterality of effusion (left or right)
| Participants | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| Left | 17 | 23 |
| Right | 32 | 28 |
Collected over 1 month following procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Drainage | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Vacuum Bottle Drainage | 0/51 (0%) | 5/51 (9.8%) | 0/51 (0%) |
| Event | Manual Drainage | Vacuum Bottle Drainage |
|---|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/49 | 3/51 |
| Clinically Significant Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 0/49 | 1/51 |
| HemothoraxRespiratory, thoracic and mediastinal disorders | 0/49 | 1/51 |
| Age, Continuous(years) | Manual Drainage | Vacuum Bottle Drainage | Total |
|---|---|---|---|
| Mean | 68.5 ± 16.2 | 65.6 ± 15.5 | 67 ± 15.8 |
| Sex: Female, Male(Participants) | Manual Drainage | Vacuum Bottle Drainage | Total |
|---|---|---|---|
| Female | 26 | 22 | 48 |
| Male | 23 | 29 | 52 |
| Race and Ethnicity Not Collected(Participants) | Manual Drainage | Vacuum Bottle Drainage | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Manual Drainage | Vacuum Bottle Drainage | Total |
|---|---|---|---|
| United States | 49 | 51 | 100 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2015 to primary completion in Sep 2017, 21 months.
Results were first posted in Aug 2018, 11 months after primary completion.
Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's 21 months is below that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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