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ACTIVE NOT RECRUITING
NCT07408388

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Sponsor: Nihon Kohden

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

48

Start Date

2025-12-03

Completion Date

2027-12-01

Last Updated

2026-02-17

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Vital Sign Research Group

San Francisco, California, United States