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Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual aspiration | Active Comparator | pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock |
|
| Wall suction | Active Comparator | pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously |
|
| Vacuum bottle drainage | Active Comparator | pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual aspiration | Procedure | One option from standard of care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time to 500mL | Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL | Through study completion, an average of 24 hours |
| Procedural time to 750mL | Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL | Through study completion, an average of 24 hours |
| Procedural time to 1L | Time to pleural fluid drainage from initiation of therapeutic drainage to 1L | Through study completion, an average of 24 hours |
| Pain and dyspnea scores- Baseline | Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) | Immediately prior to starting the thoracentesis |
| Pain and dyspnea scores- Cath | Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) | Through study completion, an average of 24 hours |
| Pain and dyspnea scores- Post-fluid | Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) | Through study completion, an average of 24 hours |
| Pain and dyspnea scores- Post-cath |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Cho, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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This is a randomized controlled, non-blinded, single-center, quality improvement study to determine which method of standard of care thoracentesis (wall suctioning, manual aspiration, or vacuum drainage) has the shortest procedural time.
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| Wall suction |
| Procedure |
One option from standard of care |
|
| Vacuum bottle drainage | Procedure | One option from standard of care |
|
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) |
| Immediately after removing the thoracentesis catheter |
| Pain and dyspnea scores- 5m post | Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) | 5 minutes post-procedure |
| Pain and dyspnea scores- 24h post | Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain) | 24 hours post-procedure |