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Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)

Hypoxia Clinical Trial

Official title:
Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 19/ 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 NCT05807477
Study type Observational
Source Nihon Kohden
Contact Philip Bickler, MD, PhD
Phone 1-415-476-1411
Email philip.bickler@ucsf.edu
Status Recruiting
Phase
Start date April 18, 2023
Completion date April 16, 2025
View Details
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