Hypoxia
Conditions
Brief summary
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
Detailed description
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.
Interventions
DEVICEPulse oximeter
Hypoxia
Sponsors
Clinimark, LLC
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is male or female * The subject is of any racial or ethnic group * The subject is \> 30 kg (\>66 pounds) in weight (self-reported) * The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement) * The subject is between 18 years and 45 years of age (self=reported) * The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form * The subject has given written informed consent to participate in the study * The subject is both willing and able to comply with study procedures.
Exclusion criteria
* The subject has a BMI greater than 31 (based on weight and height) * The subject has had any relevant injury at the sensor location site (self-reported) * The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination) * The subject is current smoker (self-reported) * The subject has a known respiratory condition (self-reported) * The subject has a known heart or cardiovascular condition (self-reported) * The subject is currently pregnant (self-reported) * The subject is actively trying to get pregnant (self-reported) * The subject has a clotting disorder (self-reported) * The subject has Raynaud's Disease (self-reported) * The subject is known to have a hemoglobinopathy (self-reported) * The subject is on blood thinners or medication with aspirin (self-reported) * The subject has unacceptable collateral circulation from the ulnar artery (based on examination) * The subject is unwilling or unable to provide written informed consent to participate in the study * The subject is unwilling or unable to comply with the study procedures * The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion | 3 days |
Countries
United States
Outcome results
None listed