Clinical trial: Palliative Oxygen for the Relief of Breathlessness (NCT00327873)

Eligibility criteria:
Inclusion Criteria:

          -  Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal
             illness where the underlying cause has been maximally treated; a medical specialist
             must document that all identified reversible causes of the dyspnea have been treated;
             PaO2 measurement must be in the last month

          -  Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the Medical
             Research Council categorical dyspnea exertion scale

          -  On stable medications over the prior week except routine "as needed" medications.

          -  Survival of at least 1 month in the opinion of the treating physician

        Exclusion Criteria:

          -  Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e.
             symptomatic pulmonary hypertension with cor pulmonale

          -  Hemoglobin<10.0g/dL as measured within one month of baseline evaluation

          -  PaCO2 >50 mm Hg.

          -  Confusion as measured by Folstein Mini-mental Status Exam <24/30

          -  Current oxygen therapy or continuous oxygen therapy in previous week

          -  Actively smoking

          -  Active respiratory or cardiac event in the previous 2 weeks, not including upper
             respiratory tract infections; illness must be resolved for at least 2 weeks prior to
             baseline evaluation, as judged by a doctor involved in the care of the patient

          -  Previous respiratory failure induced by oxygen

          -  Unable to give informed consent or complete diary entries
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