Pleural Effusion
Conditions
Keywords
pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage
Brief summary
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.
Interventions
PROCEDUREManual aspiration
One option from standard of care
PROCEDUREWall suction
One option from standard of care
PROCEDUREVacuum bottle drainage
One option from standard of care
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Evidence of pleural effusion on imaging * Clinical indication for thoracentesis
Exclusion criteria
* Age \<18 * Standard contraindication for thoracentesis procedure * Patients on positive pressure ventilation * Patients who have opted out of research in EPIC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time to 500mL | Through study completion, an average of 24 hours | Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL |
| Procedural time to 750mL | Through study completion, an average of 24 hours | Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL |
| Procedural time to 1L | Through study completion, an average of 24 hours | Time to pleural fluid drainage from initiation of therapeutic drainage to 1L |
| Pain and dyspnea scores- Baseline | Immediately prior to starting the thoracentesis | 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) |
| Pain and dyspnea scores- Cath | Through study completion, an average of 24 hours | 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) |
| Pain and dyspnea scores- Post-fluid | Through study completion, an average of 24 hours | 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) |
| Pain and dyspnea scores- Post-cath | Immediately after removing the thoracentesis catheter | 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) |
| Pain and dyspnea scores- 5m post | 5 minutes post-procedure | 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) |
| Pain and dyspnea scores- 24h post | 24 hours post-procedure | 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) |
Countries
United States
Outcome results
None listed