NCT04811963

SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor

SpO2 Accuracy Validation of the OxySoftN Sensor Via Reference CO-Oximetry in Healthy, Well-Perfused Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To compare prototype pulse oximeter 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) for non-randomized, prospective, observational studies. The goal is to enroll a minimum of ten subjects. Subjects may be of any race, ranging in pigmentation from light to dark to meet the study design requirements. The general purpose of Invasive Controlled Desaturation Studies is to validate the SpO2 and pulse rate accuracy 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 % SaO22 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. 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. In the unlikely event that the ECG monitor malfunctions, the Pulse rate reference may be taken using the average pulse rate value from the transfer standard pulse oximeters. This study is designed to support an FDA submission for pulse rate and saturation accuracy in a diverse subject population during low saturation conditions over a specified saturation range for the OxySoftN pulse oximetry system.

Conditions

• Hypoxia
• Desaturation of Blood

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: 2021-04-06
• Primary completion: 2021-04-09
• Completion: 2021-04-09
• First posted: 2021-03-23
• Last updated: 2021-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study