In Vivo Pulse Oximeter Validation Study

Completed · Not applicable

Conditions studied: Hypoxia

In brief

The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.

Key facts

Study ID

NCT05873335

Run by

Gabi SmartCare

People needed

12

Starts

2023-02-28

Expected to finish

2023-03-01

Last updated by the study team

2024-12-12

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult
• Normal hemoglobin levels (Hemoglobin > 10 g/dL)

You may not qualify if…

• Systemic illness
• Obesity

Where it is running

• Hypoxia Research Laboratory — San Francisco, California, United States

Full record on ClinicalTrials.gov

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