NCT05745675

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Nihon Kohden · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Pulse oximeter	OLV-4202 pulse oximeter SW version: 01-15)

Timeline

• Start date: 2023-01-23
• Primary completion: 2023-01-26
• Completion: 2024-04-17
• First posted: 2023-02-27
• Last updated: 2025-09-12
• Results posted: 2024-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study