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Pulse oximeter accuracy put to the test in Low-Oxygen study

NCT ID NCT05745662

Diagnosis 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a pulse oximeter device that measures blood oxygen and pulse rate without needles. Eleven healthy volunteers had their oxygen levels temporarily lowered in a controlled way to see how accurate the device was compared to blood samples. The goal was to check if the device works well even in very low oxygen conditions.

What this could mean

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

Active substance
Pulse oximeter device
What this could lead to
If successful, this could confirm that the device measures oxygen levels accurately even in very low oxygen conditions, helping doctors make better decisions.
What could go wrong
This was a small study with only 11 healthy volunteers, not patients. Results may not apply to real-world hospital settings or people with health problems.

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

11 people

The number who actually took part.

Started

Jan 2023

Finished

Apr 2024

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: * Age below 18 or over 50 * 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.