Clinical trial: Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training. (NCT01269931)

Eligibility criteria:
Patients:

        Inclusion Criteria:

          -  suspected lung cancer patients with mediastinal adenopathy

          -  at least 2 enlarged mediastinal or hilar lymph nodes (one >1.0 cm and one >1.5 cm in
             short axis on CT Chest, one of the lymph nodes must be in position 7 or 4R

          -  eighteen years of age or older

        Exclusion Criteria:

          -  Lack of informed consent

          -  any contraindication to bronchoscopy

          -  any significant severe co-morbidities (i.e. severe obstructive lung disease, active
             cardiac disease such as angina)

        Learners:

        Group 1 (EBUS-TBNA simulator training):

        Inclusion Criteria:

          -  pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months
             of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)

        Exclusion Criteria:

          -  lack of informed consent

        Group 2 (Clinical EBUS-TBNA training):

        Inclusion Criteria:

          -  pulmonary medicine trainees in the 2nd half of their final year of pulmonary training
             or recent graduates (within one year), with >50 bronchoscopy procedures experience who
             completed a one-month elective with the Interventional Pulmonary Medicine (IPM)
             service with ≥15 and ≤25 EBUS-TBNA procedures experience (n=4).

        Exclusion Criteria:

          -  lack of informed consent
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 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction