Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion

Detailed description not required.

Inclusion Criteria:

- Male or female of any race

- 18-50 years old, inclusive

- Females: negative urine pregnancy test on the day of study participation (prior to
exposure to hypoxia)

- Completed within the last year: physical exam by a licensed physician, physician
assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical
history, and blood test (complete blood count and sickle cell trait/disease
screening)

- Meets specific demographic requirements for the monitoring device under study

- Willing and able to provide written informed consent

- Able to participate for the duration of the evaluation

Exclusion Criteria:

- A room-air baseline % modulation < 1.5% on all four fingers on the test hand

- Under 18 years or over 50 years of age

- Pregnant and/or lactating women

- Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg
or diastolic pressure greater than 90 mm Hg

- Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of
more than four per minute

- History of seizures (except childhood febrile seizures) or epilepsy

- History of unexplained syncope

- Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of
anxiety disorder

- Recent history of frequent migraine headaches: average of two or more per month over
the last year

- 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.)

- History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000
feet) defined as three or more of the following symptoms: moderate to severe
headache, general malaise, dizziness/lightheadedness, nausea/vomiting,
fatigue/weakness, shortness of breath, nosebleed, persistent rapid pulse, or
peripheral edema

- History of significant respiratory disease such as severe asthma or emphysema or
sleep apnea

- Sickle cell disease or trait

- Clinically significant abnormal finding on medical history, physical examination,
clinical laboratory test or ECG. Clinical significance will be assessed by the
principal investigator or study physician as designated.

- History of stroke, transient ischemic attack or carotid artery disease

- History of myocardial ischemia, angina, myocardial infarction, congestive heart
failure or cardiomyopathy

- History of chronic renal impairment

- 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 artificial nails from
test digit(s)

- Unwillingness or inability to give informed consent

- Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g.,
Novocain) or heparin

- Recent arterial cannulation (i.e., less than 30 days prior to study date)

- Six or more arterial cannulations of each (right & left) radial artery

- History of clinically significant complications from previous arterial cannulation

- Current use of blood thinners: prescription or daily aspirin use

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