Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Part of paid clinical trials in San Francisco, California.

Sponsor
Nihon Kohden
Study ID
NCT07408388
Status
Active Not Recruiting

Conditions

  • Hypoxia

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Pulse Oximeter — DEVICE
    OLV-4202 pulse oximeter ((SW version: 01-17)
  • Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture — PROCEDURE
    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.

Study Details

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 Dates

Start date
Dec 3, 2025
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: Adult healthy subjects
    Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state

Primary Outcome Measure

Accuracy of Sensor Oxygen Saturation by Arms Calculation [ Time Frame: Up to 15 min ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vital Sign Research GroupSan FranciscoCalifornia94107-

Find similar trials in San Francisco, CA

By research site
Vital Sign Research Group· San Francisco, CA

Related Studies