Clinical trial: Bed Side Thoracentesis Among Non-Ventilated Patients With Respiratory Instability (NCT02436850)

Eligibility criteria:
Inclusion Criteria:

          1. Patients admitted to internal ward

          2. Patients with moderate to large pleural effusion per ultrasound as defined under
             Eligibility section below

          3. At least of the following findings:

               -  Dyspnea on admission notes

               -  Tachypnea (RR >18 pm)

               -  Desaturation (saturation<88%)

               -  Admission diagnosis of CHF exacerbation or any uncontrolled heart failure,

               -  Effort dyspnea per history,

               -  Acute or subacute (last two weeks) need for oxygen supplement or Noninvasive
                  ventilation.

               -  Admission diagnosis of pulmonary edema or pulmonary congestion

               -  Hypoxemia (PaO2<60mmHg)

               -  Pleuritic chest pain

        Exclusion Criteria:

          1. Subject currently enrolled in another investigational study

          2. Patients on mechanical ventilation

          3. Patients with coagulopathy (known or with any prolongation of PTT, PT, fibrinogen<200,
             platelets <100000)

          4. Patients with cognitive impairment who cannot sign informed consent

          5. Patients with sepsis or fever and pneumonia and suspected empyema

          6. Patients with any previous surgeries to the lungs

          7. Patients whom the primary team call for therapeutic TC.

          8. Patients with less than moderate amount of pleural effusion (see Eligibility criteria)

          9. Palliative patients

         10. Pregnant patients

         11. On any current anticoagulation therapy or with any abnormal coagulation study.

         12. Patients with septations or cavitation in pleural space (visible on US
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