Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)

Sponsor

Nihon Kohden (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05807464

Collaborator

University of California, San Francisco (Other)

Enrollment

Location

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia	Device: Pulse Oximeter

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

13 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 18/ Pulse Oximeter Accuracy Evaluation Protocol

Anticipated Study Start Date :

Apr 10, 2023

Anticipated Primary Completion Date :

Apr 9, 2024

Anticipated Study Completion Date :

Apr 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
Adult healthy subjects Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state	Device: Pulse Oximeter OLV-4202 pulse oximeter (SW version: 01-15)

Arm

Intervention/Treatment

Adult healthy subjects

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

Device: Pulse Oximeter

OLV-4202 pulse oximeter (SW version: 01-15)

Outcome Measures

Primary Outcome Measures

Accuracy of Sensor Oxygen Saturation by Arms Calculation [30 seconds]
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)

Secondary Outcome Measures

Accuracy of Sensor Pulse Rate by Arms Calculation [30 seconds]
Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Hypoxia Research Laboratory	San Francisco	California	United States	94133

Sponsors and Collaborators

Nihon Kohden
University of California, San Francisco

Investigators

Principal Investigator: Philip Bickler, MD, PhD, UCSF Hypoxia Research Laboratory

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Feb 28, 2023

More Information

Publications

None provided.

Responsible Party:

Nihon Kohden

ClinicalTrials.gov Identifier:

NCT05807464

Other Study ID Numbers:

72Ag_Vital-00013

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Apr 12, 2023