NCT07408388

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Nihon Kohden · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 healthy volunteers at rest.

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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2026-02-13
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States