Clinical trial: Accuracy Assessment of Beddr Oximeter (NCT03710993)

Eligibility criteria:
Inclusion Criteria:

          -  Subject must have the ability to understand and provide written informed consent

          -  Adult subjects 18 up to 50 years of age

          -  Subject must be willing and able to comply with study procedures and duration

          -  Subject is a non-smoker or who has not smoked within 2 days prior to the study.

          -  Male or female of any race

          -  Subject demographics include a range of skin pigmentations, including at least 1
             darkly pigmented subjects or 15% of the subject pool, whichever is larger.

        Exclusion Criteria:

          -  Subject is considered as being morbidly obese (defined as BMI >39.5)

          -  Compromised circulation, injury, or physical malformation of fingers, toes, hands,
             ears or forehead/skull or other sensor sites which would limit the ability to test
             sites needed for the study. (Note: Certain malformations may still allow subjects to
             participate if the condition is noted and would not affect the particular sites
             utilized.)

          -  Females who are pregnant, who are trying to get pregnant or who have a urine test
             positive for pregnancy on the day of the study

          -  Subjects with known respiratory conditions such as:

               -  uncontrolled / severe asthma,

               -  flu,

               -  pneumonia / bronchitis,

               -  shortness of breath / respiratory distress,

               -  unresolved respiratory or lung surgery with continued indications of health
                  issues,

               -  emphysema, COPD, lung disease

          -  Subjects with known heart or cardiovascular conditions such as:

               -  Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings.

               -  have had cardiovascular surgery

               -  Chest pain (angina)

               -  heart rhythms other than a normal sinus rhythm or with respiratory sinus
                  arrhythmia

               -  previous heart attack

               -  blocked artery

               -  unexplained shortness of breath

               -  congestive heart failure (CHF)

               -  history of stroke

               -  transient ischemic attack

               -  carotid artery disease

               -  myocardial ischemia

               -  myocardial infarction

               -  cardiomyopathy

          -  Self-reported health conditions as identified in the Health Assessment Form

               -  diabetes,

               -  uncontrolled thyroid disease,

               -  kidney disease / chronic renal impairment,

               -  history of seizures (except childhood febrile seizures),

               -  epilepsy,

               -  history of unexplained syncope,

               -  recent history of frequent migraine headaches,

               -  recent head injury within the last 2 months,

               -  cancer / chemotherapy

          -  Subjects with known clotting disorders

               -  history of bleeding disorders or personal history of prolonged bleeding from
                  injury

               -  history of blood clots

               -  hemophilia

               -  current use of blood thinner: prescription or daily use of aspirin

          -  Subjects with Severe contact allergies to standard adhesives, latex or other materials
             found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or
             other medical sensors

          -  Unwillingness or inability to remove colored nail polish or non-clear artificial nails
             from test digits.

          -  Other known health condition, should be considered upon disclosure in health
             assessment form
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

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