Pleural Diseases, Pleural Effusion, Thoracic Diseases
Conditions
Keywords
Pleural Effusion, Pleural Drainage, Thoracentesis
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.
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.
Interventions
DEVICEVacuum Bottle Drainage
Patients undergo drainage via vacuum bottles
Sponsors
National Institute on Aging (NIA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Had an Early Termination of Procedure | 5-20 minutes | 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). |
| Number of Patients Who Had a Complication as a Result of the Procedure | <7 days | 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 of Drainage | 5-20 minutes | Actual time of drainage in seconds for each patient. |
| Volume of Effusion | <20 minutes | Volume of effusion drained (in mL) |
| Laterality of Effusion | <20 minutes | Laterality of effusion (left or right) |
| Etiology of Effusion | <7 days | Clinical etiology of effusion |
Participant flow
Recruitment details
Inpatients, who were awake, consentable, and undergoing unilateral thoracentesis
Participants by arm
| Arm | Count |
|---|---|
| Manual Drainage Patients undergo drainage of pleural fluid via manual (syringe) system | 49 |
| 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 | 51 |
| Total | 100 |
Baseline characteristics
| Characteristic | Vacuum Bottle Drainage | Total | Manual Drainage |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 15.5 | 67 years STANDARD_DEVIATION 15.8 | 68.5 years STANDARD_DEVIATION 16.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 51 participants | 100 participants | 49 participants |
| Sex: Female, Male Female | 22 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Male | 29 Participants | 52 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 5 / 51 |
Outcome results
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.
Time frame: 5-20 minutes
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Drainage | Pain Change | 0.53 Pre-post NPRS Pain Scale Score | Standard Deviation 1.7 |
| Vacuum Bottle Drainage | Pain Change | 1.43 Pre-post NPRS Pain Scale Score | Standard Deviation 2.7 |
Secondary
Etiology of Effusion
Clinical etiology of effusion
Time frame: <7 days
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Manual Drainage | Etiology of Effusion | Heart Failure | 7 Participants |
| Manual Drainage | Etiology of Effusion | Post-Cardiothoracic Procedure | 13 Participants |
| Manual Drainage | Etiology of Effusion | Paramalignant | 7 Participants |
| Manual Drainage | Etiology of Effusion | Parapneumonic | 3 Participants |
| Manual Drainage | Etiology of Effusion | Hepatic Hydrothorax | 3 Participants |
| Manual Drainage | Etiology of Effusion | Unknown | 3 Participants |
| Manual Drainage | Etiology of Effusion | Malignant | 13 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Unknown | 8 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Malignant | 8 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Paramalignant | 2 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Heart Failure | 8 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Hepatic Hydrothorax | 5 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Post-Cardiothoracic Procedure | 17 Participants |
| Vacuum Bottle Drainage | Etiology of Effusion | Parapneumonic | 2 Participants |
Secondary
Laterality of Effusion
Laterality of effusion (left or right)
Time frame: <20 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Manual Drainage | Laterality of Effusion | Left | 17 Participants |
| Manual Drainage | Laterality of Effusion | Right | 32 Participants |
| Vacuum Bottle Drainage | Laterality of Effusion | Left | 23 Participants |
| Vacuum Bottle Drainage | Laterality of Effusion | Right | 28 Participants |
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)
Time frame: <7 days
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Manual Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Pneumothorax | 0 Participants |
| Manual Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Hemothorax | 0 Participants |
| Manual Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Clinically Significant Pulmonary Edema | 0 Participants |
| Vacuum Bottle Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Pneumothorax | 3 Participants |
| Vacuum Bottle Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Hemothorax | 1 Participants |
| Vacuum Bottle Drainage | Number of Patients Who Had a Complication as a Result of the Procedure | Clinically Significant Pulmonary Edema | 1 Participants |
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).
Time frame: 5-20 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Manual Drainage | Number of Patients Who Had an Early Termination of Procedure | 1 Participants |
| Vacuum Bottle Drainage | Number of Patients Who Had an Early Termination of Procedure | 8 Participants |
Secondary
Time of Drainage
Actual time of drainage in seconds for each patient.
Time frame: 5-20 minutes
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Drainage | Time of Drainage | 498.5 seconds | Standard Deviation 386.5 |
| Vacuum Bottle Drainage | Time of Drainage | 318.6 seconds | Standard Deviation 193 |
Secondary
Volume of Effusion
Volume of effusion drained (in mL)
Time frame: <20 minutes
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Drainage | Volume of Effusion | 1023 milliters | Standard Deviation 674 |
| Vacuum Bottle Drainage | Volume of Effusion | 1143 milliters | Standard Deviation 775 |