Healthy, Hypoxia
Conditions
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.
Interventions
DEVICEArterial line
Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
DEVICEMotion
The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy During Motion Conditions - MaxA Sensor | up to 6 months | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit. |
| SpO2 Accuracy During Motion Conditions - MaxN Sensor | up to 6 months | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| no Treatment | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | no Treatment |
|---|---|
| Age, Continuous | 33.67 years STANDARD_DEVIATION 8.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
SpO2 Accuracy During Motion Conditions - MaxA Sensor
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Treatment | SpO2 Accuracy During Motion Conditions - MaxA Sensor | 1.78 Accuracy Root Mean Square |
Primary
SpO2 Accuracy During Motion Conditions - MaxN Sensor
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Treatment | SpO2 Accuracy During Motion Conditions - MaxN Sensor | 1.93 Accuracy Root Mean Square |