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

a study on Hypoxia

Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Philip Bickler, MD, PhD
Headshot of Philip Bickler
Philip Bickler

Description

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.

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

Details

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.

Keywords

Hypoxia, Pulse Oximeter

Eligibility

You can join if…

Open to people ages 18-50

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF Hypoxia Research Laboratory accepting new patients
    San Francisco California 94133 United States

Lead Scientist at UCSF

  • Philip Bickler, MD, PhD
    Professor, Anesthesia, School of Medicine. Authored (or co-authored) 129 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nihon Kohden
ID
NCT05807464
Study Type
Observational
Participants
Expecting 13 study participants
Last Updated
Contact us about this trial