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NCT Number: NCT05297500

Determination of SpO2 and PR Accuracy Specifications at Rest (71Ag_Vital-0031)

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Hypoxia Research Laboratory

San Francisco, California, 94133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Pulse Oximeter

Device

OLV-4202 pulse oximeter (SW version: 01-12)

Primary outcomes

  1. Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%)

    Time frame: 30 minutes

    Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:

    room air, 92%, 87%, 82%, 77%, 72%

    Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:

    100%, 93%, 88%, 83%, 78%, 73%

    SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.

  2. Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min])

    Time frame: 30 minutes

    Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:

    room air, 92%, 87%, 82%, 77%, 72%

    Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:

    100%, 93%, 88%, 83%, 78%, 73%

    Pulse rate is recorded from the test device and from the reference ECG monitor. PR data measurements are gathered during the stable plateau value at the desired saturation target. Each desaturation plateaus should not exceed 10 minutes. The gas mixture is then changed for the next value and repeated for each plateau value.

Secondary outcomes

  1. Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at desaturation levels (80% to 100%) and within +-3% [%SpO2] at desaturation levels (70% to 80%)

    Time frame: 30 minutes

    Each subject will have an arterial catheter inserted in the left or right wrist and the pulse oximeter study device placed on different fingers of the left or right hand, or the left or right earlobe or the forehead. Measurement position is randomized across subjects. For each subject, a series of desaturation runs are performed.

    Run 1 stabilized room air period -> stabilized plateaus at saturation level targets:

    room air, 92%, 87%, 82%, 77%, 72%

    Run 2 stabilized 100% O2 period -> stabilized plateaus at saturation level targets:

    100%, 93%, 88%, 83%, 78%, 73%

    SpO2 is observed breath by breath arterial saturation, which is in turn computed from end tidal PO2 and PCO2. FiO2 is reduced suddenly at first then adjusted to achieve a stable plateau value at the desired target. Each desaturation plateaus should not exceed 10 minutes. A blood draw is taken at stable FiO2 and +30 seconds. The gas mixture is then changed for the next value and repeated for each plateau value.

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 14

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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