Clinical trial: Gravity- Versus Suction-driven Large Volume Thoracentesis (NCT03591952)

Eligibility criteria:
Inclusion Criteria:

          1. Referral to pulmonary services for large-volume thoracentesis

          2. Presence of a symptomatic moderate or large free-flowing (non-septated) pleural
             effusion on the basis of:

               1. Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR

               2. 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.

          3. Age > 18

        Exclusion Criteria:

          1. Inability to provide informed consent

          2. Patient has already been enrolled in this study

          3. Study subject has any disease or condition that interferes with safe completion of the
             study including:

               1. Coagulopathy, with criteria left at the discretion of the operator

               2. 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

          4. Pleural effusion is smaller than expected on bedside pre-procedure ultrasound

          5. Referral is for diagnostic thoracentesis only

          6. Presence of more than minimal septations and/or loculations on bedside pre-procedure
             ultrasound

          7. Inability to sit for the procedure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? 1