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Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO16)

Hypoxia Clinical Trial

Official title:
Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol

Clinical Trial Summary

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Clinical Trial Description

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05745675
Study type Observational
Source Nihon Kohden
Contact
Status Active, not recruiting
Phase
Start date January 23, 2023
Completion date January 25, 2024
View Details
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