NCT05532670

N600X Low Saturation Accuracy Validation

SpO2 Accuracy Validation of N600x Sensors Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Non-Invasive Controlled Hypoxia	Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.

Timeline

• Start date: 2022-09-29
• Primary completion: 2022-10-07
• Completion: 2022-11-01
• First posted: 2022-09-08
• Last updated: 2022-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study