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CompletedNCT06432881Updated Jul 16, 2026

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

An interventional study of RD SET Sensor in Hypoxemia, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Masimo Corporation (part of Danaher Corporation) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
461
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypoxemia

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03

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's enrollment of 461 is above the median of 45 across 769 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.

First submitted before Masimo Corporation became part of Danaher Corporation.

Browse Masimo Corporation studies →All Danaher Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
461 participants (actual)

Study arms

  • Experimental
    RD SET Sensor

    All subjects are enrolled into this arm and will have Sp02 measurements obtained.

    Device: RD SET Sensor

Interventions

  • DeviceRD SET Sensor

    All subjects are enrolled into this arm and will have Sp02 measurements obtained.

06

What researchers measure

Primary outcomes

  1. Investigation of skin pigmentation effect on performance of Masimo pulse oximetry

    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.

    Time frame: Approximately 30 minutes

07

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jul 2026, 29 months.

Of 30 industry-sponsored interventional studies with no phase under Hypoxia, half reached primary completion within 1 month of starting (the median), counting those still running; a quarter within 0 and three quarters within 6. This study's 29 months is above that.

Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2024
First posted
May 29, 2024
StartActual
Jan 8, 2024
Primary completionActual
Jul 7, 2026
CompletionActual
Jul 7, 2026
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06432881
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
May 29, 2024
Start date
Jan 8, 2024
Primary completion
Jul 7, 2026
Completion
Jul 7, 2026
Last update
Jul 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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