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

NCT05807464 | Completed Results FDA Device

• 1 other identifier: 72Ag_Vital-00013
• 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 (1)

• Accuracy of Sensor Oxygen Saturation by Arms Calculation

  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)

  30 seconds

Secondary Outcomes (1)

• Accuracy of Sensor Pulse Rate by Arms Calculation

  30 seconds

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: 01-15)

Adult healthy subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• 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 3 will be dark pigmented (FItzpatrick Scale Type 4, 5 or 6). If the number of samples is less than the required 200 or if less than 3 of dark pigment subjects successfully complete the study, subjects will be added to include 3 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:

• 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

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

Limitations and Caveats

The study was reviewed and approved by the University of California at San Francisco Committee on Human Research. The approval letter is on file at UCSF.

Results Point of Contact

• Title: Dr. Philip Bickler
• Organization: UCSF Hypoxia Research Laboratory

philip.bickler@ucsf.edu

1-415-476-1411

Study Officials

• Philip Bickler, MD, PhD

  UCSF Hypoxia Research Laboratory

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 12, 2023
• Primary Completion: April 13, 2023
• Study Completion: May 8, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 20, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)