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New pulse oximeter put to the test in extreme Low-Oxygen conditions

NCT ID NCT05297500

Knowledge-focused Sponsor: Nihon Kohden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks how accurately a new pulse oximeter (a device that measures blood oxygen through the skin) works when oxygen levels are dangerously low. Twelve healthy volunteers will have their oxygen temporarily lowered in a controlled setting while the device's readings are compared to standard blood tests. The goal is to see if the device stays accurate even in extreme conditions, which could help doctors monitor patients better in emergencies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could confirm that the device reliably measures oxygen levels even during severe hypoxia, potentially improving patient safety in hospitals.
What could go wrong
This is a small, early-stage device validation study in healthy volunteers, not patients. Real-world performance may differ, and the device may not be approved or widely adopted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant women * Significant arrhythmia * Blood pressure above 150 systolic or 90 diastolic * Carboxyhemoglobin levels over 3% * Subjects whom the investigator consider ineligible for the study

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxia

Contacts and locations

Locations

  • UCSF Hypoxia Research Laboratory

    San Francisco, California, 94133, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.