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Does skin color affect oxygen readings? new study in kids aims to find out

NCT ID NCT07168798

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks whether a Nihon Kohden pulse oximeter accurately measures blood oxygen in 180 children aged 0-12 with various skin tones. All children are in a cardiac intensive care unit and already have an arterial line for standard care. The goal is to see if the device's readings match the true oxygen level from blood samples, and whether skin color affects accuracy.

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 (OLV-4201 with sensors)
What this could lead to
If successful, this could lead to more accurate oxygen monitoring for children of all skin colors, reducing hidden low oxygen levels in darker-skinned patients.
What could go wrong
This is an observational accuracy study, not a treatment trial. It may show differences but won't directly improve care. Results may not apply to all devices or settings.

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

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

Children in hospital setting

Ages

0 days to 12 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: * Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care Exclusion Criteria: * Patients with elevated levels of methemoglobin and carboxyhemoglobin, or anemia. * Patients with prolonged hypotension at the time of enrollment. * Patients with ductal-dependent congenital cardiac disease.

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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.

Hypoxemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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