Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

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 healthy volunteers at rest.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypoxia
• Intervention / Treatment: Device: Pulse Oximeter; Procedure: Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture

Detailed Description

This study will evaluate the accuracy of Nihon Kohden pulse oximeters and sensors in measuring arterial oxygen saturation (SpO₂) in healthy adult volunteers. Subjects will undergo controlled reductions in blood oxygen levels (down to 70%) while SpO₂ readings from the test devices are compared to reference values from arterial blood samples. The study is designed to meet current ISO and FDA requirements, and results may be used to support regulatory submissions. Data will be analyzed for overall accuracy and potential differences by skin tone and sex.

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Vital Sign Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers. At least 48 new subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.

Description

Inclusion Criteria:

• The subject is male or female, aged 18 to 50.
• The subject is in good general health with no evidence of any medical problems
• The subject is fluent in both written and spoken English.
• The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject has a BMI above 40
2. The subject has blood pressure above 160 systolic or 95 diastolic
3. The subject has a known history of heart disease, lung disease, kidney or liver disease.
4. Diagnosis of asthma, sleep apnea, or use of CPAP.
5. Subject has diabetes.
6. Subject has a clotting disorder.
7. The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. (COHb<3%, MetHb<2%, ctHb>10 g/dL).
8. The subject has any other serious systemic illness.
9. The subject has smoked in the last 12 hours.
10. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
11. The subject has a history of fainting or vasovagal response.
12. The subject has a history of sensitivity to local anesthesia.
13. The subject has a diagnosis of Raynaud's disease.
14. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
15. The subject is pregnant, lactating or trying to get pregnant.
16. Subjects who have uneven skin tones at the forehead or the sensor site.
17. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
18. The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; OLV-4202 pulse oximeter ((SW version: 01-17); Procedure: Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture; Subjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation. Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Sensor Oxygen Saturation by Arms Calculation	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)	Up to 15 min

Collaborators and Investigators

• Sponsor: Nihon Kohden
• Investigators: Principal Investigator: Greg Stratmann, MD, PhD, University of California, San Francisco, Department of Anesthesia and Perioperative Care

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypoxia; SpO2; Pulse oximetry; Pulse oximeter
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: 75Ag-00030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Company confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No