NCT05873335

In Vivo Pulse Oximeter Validation Study

In Vivo Testing for SpO2 Accuracy on Healthy Adults Under Laboratory Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Gabi SmartCare · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Mixtures of nitrogen, air, and carbon dioxide	Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015

Timeline

• Start date: 2023-02-28
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2023-05-24
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study