controlled acute hypoxia study comparing pulse oximetry to arterial blood samples during motion

Conditions: Healthy; Hypoxia

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

use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.

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.