Clinical trial: Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia (NCT04380389)

Eligibility criteria:
Inclusion Criteria:

          -  The subject is male or female, aged ≥18 and <50.

          -  The subject is in good general health with no evidence of any medical problems.

          -  The subject has both wrist circumferences between 14 and 22cm.

          -  The subject has provided informed consent and is willing to comply with the study
             procedures.

        Exclusion Criteria:

          -  The subject is obese (BMI>30).

          -  The subject has a known history of heart disease, lung disease, kidney or liver
             disease.

          -  Diagnosis of asthma, sleep apnea, or use of CPAP.

          -  Subject has diabetes.

          -  Subject has a clotting disorder.

          -  The subject a hemoglobinopathy or history of anemia, per subject report or the first
             blood sample that in the opinion of the investigator, would make them unsuitable for
             study participation.

          -  The subject has any other serious systemic illness.

          -  The subject is a current smoker.

          -  The subject has piercings that may cause air leaks during the test

          -  The subject has any injury, deformity, or abnormality at the sensor sites that in the
             opinion of the investigators' would interfere with the sensors working correctly.

          -  The subject has a history of fainting or vasovagal response.

          -  The subject has a history of sensitivity to local anesthesia.

          -  The subject has a diagnosis of Raynaud's disease.

          -  The subject has unacceptable collateral circulation based on exam by the investigator
             (Allen's test).

          -  The subject is pregnant, lactating or trying to get pregnant.

          -  The subject is unable or unwilling to provide informed consent, or is unable or
             unwilling to comply with study procedures.

          -  The subject has a resting heartrate over 120, Systolic BP is over 150, diastolic BP is
             over 90 or room air SpO2 is less than 94%.

          -  The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.

          -  The subject has any other condition, which in the opinion of the investigators' would
             make them unsuitable to participate.
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 49 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment