Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

May 14, 2026 updated by: Masimo Corporation
The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RD SET Sensor
All subjects are enrolled into this arm and will have Sp02 measurements obtained.
Device: RD SET Sensor
All subjects are enrolled into this arm and will have Sp02 measurements obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
Time Frame: Approximately 30 minutes
The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin.
Approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOOD0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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