NCT06661889

OM2 Low Saturation Verification

Low Saturation Verification of Investigational Pulse Oximetry Devices in Adult Volunteers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Detailed description

To verify the SpO2 and pulse rate accuracy in comparison to a reference standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steadystate saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.

Conditions

• Hypoxia

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-02-27
• Completion: 2025-05-27
• First posted: 2024-10-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States