Controlled Acute Hypoxia Study - Abbreviated Sensor Line
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 11/8/2014 |
Start Date: | August 2014 |
End Date: | September 2014 |
Contact: | Julie Gunzner |
Email: | julie.gunzner@covidien.com |
Phone: | 303-305-2205 |
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples Using the Abbreviated Sensor Line in Healthy Subjects With the USB Pulse Oximetry Monitor Interface Cable
The primary objective of the study is to validate the proposed claims for the OxiCable
device, for pulse rate and saturation accuracy in a diverse subject population over a
specified saturation range.
device, for pulse rate and saturation accuracy in a diverse subject population over a
specified saturation range.
Detailed description is not needed.
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:
- 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
- Premature ventricular contractions (PVCs) 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
site 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
- 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 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
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