Hypoxia
Conditions
Brief summary
The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
Detailed description
The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
Interventions
OTHERPulse Oximeter
Pulse Oximeter
Sponsors
Nonin Medical, Inc
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 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 50 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, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study * 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 | Description |
|---|---|---|
| SpO2 Hypoxia Accuracy Validation Study | Through study completion, 3 months average | Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device. |
Countries
United States
Outcome results
None listed