Gravity- Versus Suction-driven Large Volume Thoracentesis (NCT03591952) | Clinical Trial Compass
CompletedNot Applicable
Gravity- Versus Suction-driven Large Volume Thoracentesis
United States138 participantsStarted 2018-08-01
Plain-language summary
Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Referral to pulmonary services for large-volume thoracentesis
✓. Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
✓. Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
✓. CT-scan: maximum AP depth of the effusion ≥ 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR Ultrasound: effusion spanning at least three interspaces, with depth of 3 cm or greater in at least one interspace, while the patient sits upright.
✓. Age \> 18
Exclusion criteria
✕. Inability to provide informed consent
✕. Patient has already been enrolled in this study
✕. Study subject has any disease or condition that interferes with safe completion of the study including:
✕. Coagulopathy, with criteria left at the discretion of the operator
✕. Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians
✕. Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
✕. Referral is for diagnostic thoracentesis only
What they're measuring
1
Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups
Timeframe: One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)