Actively Recruiting
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
Led by Masimo Corporation · Updated on 2026-04-02
152
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 defined by need for supplemental oxygen or peripheral oxygenation �3C= 94% on room air.
You will not qualify if you...
- Pulse oximetry cannot be reliably performed on both the third and fourth digits of the hand with the arterial line (e.g., due to amputation or deformity).
- Skin conditions affecting the digits where the sensor is applied, such as psoriasis, eczema, angioma, scar tissue, burns, fungal infection, or substantial skin breakdown.
- Distinct geographic skin pigmentation differences (e.g., vitiligo) on the digit where the sensor is applied.
- Presence of nail polish or acrylic nails on the digits where the sensor needs to be applied.
- Known allergic reactions to adhesive tapes.
- Arterial catheter placed in a lower extremity.
- Subject deemed unsuitable for the study by the investigator or clinical team.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
C
Chelsea Frank
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here