Clinical trial: Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. (NCT02723032)

Eligibility criteria:
Healthy volunteers

        Inclusion Criteria:

          -  Age 18 - 60 years,

          -  Non smoker,

          -  Good general health and physical fitness

          -  Informed Consent

        Exclusion Criteria:

          -  Current or history of tobacco smoking (> 5 py)

          -  Current alcohol or drug abuse

          -  Heart disease or untreated arterial hypertension

          -  Pulmonary disease

          -  Epilepsy or other major neurologic disease

          -  Dark skin colour

          -  Known anemia

          -  Severe metabolic disease (e.g. diabetes)

          -  Pregnancy

        Patients

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Long term oxygen therapy at rest and/or on physical effort

          -  Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or < 60 mmHg with PHT
             or polycythemia (men Hb > 174 g/L, women Hb > 140 g/L) or:

        Oxygen desaturation on effort (SpO2 < 90%)

          -  Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung
             Disease and Sarcoidosis

          -  Informed Consent

        Exclusion Criteria:

          -  Severe hypoxemia (pO2 <40 mmHg)

          -  Severe hypercapnia (pCO2 >55 mmHg)

          -  Acute respiratory infection or systemic infection,

          -  Severe systolic heart disease (LVEF < 25%)

          -  Myocardial infarction during the last month before inclusion

          -  Unstable angina pectoris

          -  Severe aortic stenosis (mean gradient > 40mmHg, valve area <1 cm2)

          -  Rhythmogenic heart disease

          -  Severe or untreated arterial hypertension (blood pressure > 180mmHg systolic, >100mmHg
             diastolic)

          -  Anemia (Hb < 120 g/l)

          -  Known or suspected coagulation disorder (e.g. INR > 4)

          -  Severe or untreated metabolic disorder

          -  Neurologic disease or dementia

          -  Pregnancy

          -  History of non-compliance to medical treatment

          -  Current alcohol, drug abuse or current tobacco smoking

          -  Dark skin color
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction