Status:
COMPLETED
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Lead Sponsor:
Medtronic - MITG
Conditions:
Healthy
Hypoxia
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
Detailed Description
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02247765
Start Date
November 1 2014
End Date
December 1 2014
Last Update
May 5 2017
Active Locations (2)
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1
Boulder Clinical Laboratory
Boulder, Colorado, United States, 80301
2
Covidien RMS
Boulder, Colorado, United States, 80301