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

Medtronic

Status and phase

Completed

Phase 3

Conditions

Healthy

Hypoxia

Treatments

Device: Motion

Device: Arterial line

Study type

Interventional

Funder types

Industry

Identifiers

NCT02247765

COVMOPR0445

Details and patient eligibility

About

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

Full description

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

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.