SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

Completed · Not applicable

Conditions studied: Hypoxia

In brief

Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.

Key facts

Study ID

NCT03630016

Run by

Owlet Baby Care, Inc.

People needed

11

Starts

2017-12-13

Expected to finish

2017-12-17

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
• Subject must have the ability to understand and provide written informed consent
• Subject is 18 to 50 years of age
• At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who have not smoked within 2 days prior to the study.

You may not qualify if…

• Subject is considered as being morbidly obese (defined as BMI >39.5)
• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
• Females who are pregnant, who are trying to get pregnant
• Smoker Subjects who have refrained will be screened for COHb levels
• Subjects with known heart or cardiovascular conditions
• Subjects with known clotting disorders

Where it is running

• Owlet Baby Care, Inc. — Lehi, Utah, United States

Full record on ClinicalTrials.gov

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