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Pulse oximeters may be less accurate for darker skin – new study investigates

NCT ID NCT06432881

Knowledge-focused Sponsor: Masimo Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 3 times

Summary

This study looks at whether skin pigmentation affects how well Masimo pulse oximeters measure oxygen levels. Researchers will compare readings from 152 ICU patients with light and dark skin who have low oxygen levels. The goal is to see if the device works equally well for everyone.

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 improve pulse oximeter accuracy for people with darker skin, leading to better oxygen monitoring in hospitals.
What could go wrong
This is an observational device study, not a treatment trial. It may show differences but won't directly change patient care yet.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

461 people

The number who actually took part.

Started

Jan 2024

Finished

Jul 2026

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.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Subject is 18 years of age or older. * Subject is receiving care in an intensive care unit. * Subject with an arterial catheter in place. * Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air Exclusion Criteria: * Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity). * Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). * Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care. * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied. * Subjects with known allergic reactions to adhesive tapes. * Subjects with arterial catheter placed in a lower extremity. * Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.

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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

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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