Hypoxia Clinical Trial - OM2 Motion Verification Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements during motion and non-motion conditions. 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 steady-state 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. ;

Study Design

Related Conditions & MeSH terms

Hypoxia

Clinical Trial Details

NCT number	NCT06415786
Study type	Observational
Source	Medtronic - MITG
Contact
Status	Completed
Phase
Start date	March 7, 2024
Completion date	March 27, 2024

View Details

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