Hypoxia
Conditions
Brief summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Interventions
DEVICEBabySat V3
Evaluation of Accuracy of BabySat V3
Sponsors
University of California, San Francisco
Owlet Baby Care, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 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 |
|---|---|---|
| Evaluation of accuracy during motion | During the oxygen desaturation assessment | Determine the accuracy during varying degrees of motion and oxygen saturation |
Countries
United States
Outcome results
None listed