HypoxemiaNCT06432881
Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
A study testing RD SET Sensor in people with Hypoxemia, run by Masimo Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- RD SET Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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
- Hypoxemia
- Being tested
- RD SET Sensor
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD SET SensorDevice
All subjects are enrolled into this arm and will have Sp02 measurements obtained.
| Study group | Role | What they receive |
|---|---|---|
| RD SET Sensor | Experimental | All subjects are enrolled into this arm and will have Sp02 measurements obtained. Receives: Device: RD SET Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start8 Jan 2024
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432881
- Sponsor's protocol ID
- GOOD0001
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
- ClinicalTrials.gov ID
- NCT06432881
- Acronym / sponsor ID
- GOOD0001
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD SET Sensor | Experimental | Device: RD SET SensorAll subjects are enrolled into this arm and will have Sp02 measurements obtained. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD SET SensorAll subjects are enrolled into this arm and will have Sp02 measurements obtained. | Device | RD SET Sensor |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD SET Sensor in people with Hypoxemia, run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of skin pigmentation effect on performance of Masimo pulse oximetry (time frame: Approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.