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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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
. Presence of more than minimal septations and/or loculations on bedside pre-procedure ultrasound