NCT06101654

Accuracy of Evie Ring Pulse Oximeter in Profound Hypoxia

Accuracy of the Evie Ring Pulse Oximeter in Profound Hypoxia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Movano Health · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per ISO 80601-2-61:2019. Four devices were placed on each subject with two on each index finger at the base and two on each index finger at the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Detailed description

The study is an open enrollment, single-center, single blinded design using the investigational ring compared to arterial blood gas measurements (SaO2) and to two commercially available hospital grade reference pulse oximeters (Massimo Radical-7 and Nellcor N-595). To be included in the study, subjects had to meet all the inclusion criteria and not meet any of the exclusion criteria and to sign the written consent. Demographic data were obtained. The investigational (4/subject) and reference devices were placed. A radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. Each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. Hands with test devices and reference pulse oximeters were maintained motionless on arm boards throughout the test. Hypoxemia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide. The mixture of gases was controlled by the study physician by adjusting gas flows according to breath-by-breath estimates of oxygen saturation calculated from end-tidal partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2). Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until readings were stable. Two arterial blood samples were then obtained, approximately 30 seconds apart. Each stable plateau was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. All investigational, control, and reference data were recorded.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Pulse oximeter	Devices (4) were placed on the finger and the fingertip of both index fingers. Blood samples were taken at each stable level of oxygenation.

Timeline

• Start date: 2024-01-09
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2023-10-26
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study