Clinical trial: Impact of Pleural Manometry on Chest Discomfort After Therapeutic Thoracentesis (NCT02677883)

Eligibility criteria:
Inclusion Criteria:

          -  Referral to pulmonary or interventional radiology services for large-volume
             thoracentesis

          -  Presence of a symptomatic moderate or large free-flowing pleural effusion on the basis
             of:

               -  Chest radiograph: effusion filling >= 1/3 the hemithorax, OR

               -  Computed tomography (CT)-scan: maximum anteroposterior (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 rib spaces with depth of >= 3 cm

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  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

          -  Manometry felt to be clinically indicated

          -  Inability to assume or maintain a seated position for the procedure

          -  Presence of multiple loculations on bedside pre-procedure ultrasound
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 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? Entailment