Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Intervention: Arterial line; Motion
Intervention description: Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601; The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject
      population during motion over a specified saturation range.
    

Eligibility criteria:

        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.