Oximetry
Conditions
Keywords
Oximetry, Wearable, SpO2
Brief summary
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
Interventions
DEVICEEmbracePlus
A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings. Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.
Sponsors
Empatica Srl
Empatica, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is male or female, aged ≥18 and \<50. * The subject is in good general health with no evidence of any medical problems. * The subject is fluent in both written and spoken English. * The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion criteria
* The subject is obese (BMI\>30). * The subject has a known history of heart disease, lung disease, kidney or liver disease. * Diagnosis of asthma, sleep apnea, or use of CPAP. * Subject has diabetes. * Subject has a clotting disorder. * The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. * The subject has any other serious systemic illness. * The subject is a current smoker. * Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. * The subject has a history of fainting or vasovagal response. * The subject has a history of sensitivity to local anesthesia. * The subject has a diagnosis of Raynaud's disease. * The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). * The subject is pregnant, lactating or trying to get pregnant. * The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. * The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy | Through study completion, 3 months average | SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter |
Countries
United States
Outcome results
None listed