Hypoxia Clinical Trial - N600X Low Saturation Accuracy Validation

Status Completed

Clinical Trial Summary

To compare pulse oximetry saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

Clinical Trial Description

The study utilizes a single-site, physiology laboratory (Clinimark) to conduct this Post Market, non-randomized, prospective studies. The goal is to enroll a minimum of fifteen subjects. Subject pool goal of diversity across ethnicity, race and sex of varying skin tones to meet the study design requirements. The general purpose of Invasive Controlled Desaturation Studies is to support the SpO2 accuracy of the post market pulse oximetry sensors and paired monitor in comparison to reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation conditions. This is achieved through paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of 60% to 100% SaO2 of the 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. Arterial blood samples are periodically taken from an indwelling arterial catheter for use in the comparison. Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be compared to reference ECG heart rate. ;

Study Design

Related Conditions & MeSH terms

Hypoxia

Clinical Trial Details

NCT number	NCT05532670
Study type	Observational
Source	Medtronic - MITG
Contact
Status	Completed
Phase
Start date	September 29, 2022
Completion date	November 1, 2022

View Details

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