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

NCT05297500 | Active Not Recruiting FDA Device

• 1 other identifier: 71Ag_Vital-0031
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (2)

• 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%)

  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.

  30 minutes

• 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])

  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.

  30 minutes

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%)

  30 minutes

Study Arms (1)

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

Interventions

Pulse oximeter DEVICE

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

Adult healthy subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Nihon Kohden: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCSF Hypoxia Research Laboratory

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: March 23, 2022
• Primary Completion: March 28, 2022
• Study Completion (Estimated): October 29, 2026
• Last Updated: November 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)