An interventional study of Manual aspiration and Wall suction in Pleural Effusion, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.
This study's enrollment of 102 is above the median of 63 across 212 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock
Procedure: Manual aspiration
pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously
Procedure: Wall suction
pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container
Procedure: Vacuum bottle drainage
One option from standard of care
One option from standard of care
One option from standard of care
Procedural time to 500mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
Time frame: Through study completion, an average of 24 hours
Procedural time to 750mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Time frame: Through study completion, an average of 24 hours
Procedural time to 1L
Time to pleural fluid drainage from initiation of therapeutic drainage to 1L
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Through study completion, an average of 24 hours
Pain and dyspnea scores- Post-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)
Time frame: 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)
Time frame: 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)
Time frame: 24 hours post-procedure
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Minnesota