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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Masimo Corporation
Study ID
NCT06432881
Status
Recruiting

Conditions

  • Hypoxemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • RD SET Sensor — DEVICE
    All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Study Details

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.

Key Dates

Start date
Jan 8, 2024
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
152 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: RD SET Sensor
    All subjects are enrolled into this arm and will have Sp02 measurements obtained.

Primary Outcome Measure

Investigation of skin pigmentation effect on performance of Masimo pulse oximetry [ Time Frame: Approximately 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Chelsea Frank
949-297-7000

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