Hypoxia
Conditions
Brief summary
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.
Interventions
DEVICEANNE Limb Sensor
Pulse Oximeter
Sponsors
Sibel Health Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is male or female, between the ages of 18 and 55 years. * 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
* 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 has 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 * Th 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 |
|---|---|---|
| ARMS of SpO2 Measurements with ANNE Limb compared to SaO2 | 1 hour | Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2) |
Countries
United States
Outcome results
None listed