Accuracy of Pulse Oximeters With Profound Hypoxia During Motion

NCT04814342 | Completed Results FDA Device

• 1 other identifier: 70Ag_Vital-00008
• Study Type: observational
• Target: 5
• 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 during controlled motion.

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

Interventions

Pulse oximeter DEVICE

OLV-4202 pulse oximeter (SW version: 01-11)

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 5 subjects will be recruited to complete the study. Of these, 2 will be dark pigmented.

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
• 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

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 22, 2021
• First Posted: March 24, 2021
• Study Start: March 24, 2021
• Primary Completion: May 24, 2021
• Study Completion: February 15, 2022
• Last Updated: September 12, 2025
• Results First Posted: November 21, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)