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

Nihon Kohden

Status: Completed

Conditions: Hypoxia

Treatments: Device: Pulse oximeter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05745675

70Ag_Vital-00017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Both male and female subjects who can give written informed consent
• Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
• Meeting the demographic requirements

Exclusion criteria

• Age below 18 or over 50
• Pregnant women
• Significant arrhythmia
• Blood pressure above 150 systolic or 90 diastolic
• Carboxyhemoglobin levels over 3%
• Subjects whom the investigator consider ineligible for the study

Trial design

11 participants in 1 patient group

Adult healthy subjects

Description:

Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state

Treatment:

Device: Pulse oximeter