Clinical trial NCT02247765: Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
Official title: Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Hypoxia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: SpO2 Accuracy During Motion Conditions - MaxA Sensor
timeFrame: up to 6 months
measure: SpO2 Accuracy During Motion Conditions - MaxN Sensor
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Clinical Laboratory
state: Colorado
city: Boulder
country: United States
facility: Covidien RMS
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Eric Heyer, MD
role: PRINCIPAL_INVESTIGATOR
References: