HypoxemiaNCT05690269
Oximeters and Skin Pigment: Impact of Skin Pigmentation on Accuracy of Pulse Oximetry
An observational study of Hypoxemia and Hyperoxia, run by University of Cincinnati at 1 site in United States.
Trial summary
Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Hyperoxia, Pigment Skin
- What is being tested?
- SpO2 and SaO2 comparison
- Type of treatment
- Medical device
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 31 Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- ≥ 18 years old
- Patients admitted to the Intensive Care Unit
- Patient has arterial line
Who cannot join
- No signal with the oximeter
- Missing digits preventing application of all probes simultaneously
- No requirement for arterial blood gases
- Pigmented nails, fake nails, or nail polish
- Methemoglobinemia
- Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Skin Pigmentation on Accuracy of Pulse Oximetry
Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation.
This study aims to evaluate different FDA approved pulse oximeters (Nonin co-pilot, massimo Radical 7, Philips-standard of care monitor, innovo premium iP900BP, nellcor PM1000N, Nano100) with SaO2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.
Read the detailed description
The oximeters that will be evaluated are nonin co-pilot, massimo Radical 7, Philips (standard care), Innovo Premium iP900BP, nellcor PM1000N and USA medical supply Nano100. The sensors used will be reusable digital sensors for all oximeters. Oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. Due to the impact of the fingers used for SpO2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. Measurements will be made when the SpO2 with the usual oximeter is <97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. A set of measures that will include all the oximeters tested will be used. Once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. Then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the ICU. While the clinician takes the arterial blood gas, a picture will be simultaneously taken of the SpO2 readings shown by each oximeter, in addition to taking vital signs, O2 flow or FiO2.
- Conditions
- Hypoxemia, Hyperoxia, Pigment Skin
- Being tested
- SpO2 and SaO2 comparison
- Keywords
- SpO2, SaO2,Hypoxemia
- Medical subject headings
- Hypoxia, Hyperoxia, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 and SaO2 comparisonDevice
Several pulse oximeter will be place on patients fingers a few minutes before arterial blood gases. SpO2 will be recorded during that time and up to 10 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between SpO2 and the SaO2 value in all studied oximeters
Difference between oximeter SpO2 and the corresponding SaO2 value
Measured: At the time of arterial blood samples collection. Approximately 15 minutes.
Secondary outcomes (1)
Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia
Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia (body temperature < 34 degrees C) and subjects requiring vasoactive infusions.
Measured: At the time of arterial blood samples collection. Approximately 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start27 Feb 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
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.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Dina Gomaa, University of Cincinnati
- Investigators
- Dina Gomaa, MSc, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690269
- Sponsor's protocol ID
- HRP-503
- Status last verified
- May 2025
- First submitted
- 20 Dec 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Skin Pigmentation on Accuracy of Pulse Oximetry
- ClinicalTrials.gov ID
- NCT05690269
- Acronym / sponsor ID
- HRP-503
- Conditions
- Hypoxemia, Hyperoxia, Pigment Skin
- Keywords
- SpO2, SaO2,Hypoxemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Jan 2023 (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.
Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation.
This study aims to evaluate different FDA approved pulse oximeters (Nonin co-pilot, massimo Radical 7, Philips-standard of care monitor, innovo premium iP900BP, nellcor PM1000N, Nano100) with SaO2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.
Detailed description
The oximeters that will be evaluated are nonin co-pilot, massimo Radical 7, Philips (standard care), Innovo Premium iP900BP, nellcor PM1000N and USA medical supply Nano100. The sensors used will be reusable digital sensors for all oximeters. Oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. Due to the impact of the fingers used for SpO2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. Measurements will be made when the SpO2 with the usual oximeter is <97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. A set of measures that will include all the oximeters tested will be used. Once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. Then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the ICU. While the clinician takes the arterial blood gas, a picture will be simultaneously taken of the SpO2 readings shown by each oximeter, in addition to taking vital signs, O2 flow or FiO2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Patients admitted to the Intensive Care Unit
- Patient has arterial line
Key exclusion criteria (6 listed)
- No signal with the oximeter
- Missing digits preventing application of all probes simultaneously
- No requirement for arterial blood gases
- Pigmented nails, fake nails, or nail polish
- Methemoglobinemia
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 |
|---|---|---|
| SpO2 and SaO2 comparisonSeveral pulse oximeter will be place on patients fingers a few minutes before arterial blood gases. SpO2 will be recorded during that time and up to 10 minutes. | Device | – |
Primary outcome
Difference between SpO2 and the SaO2 value in all studied oximeters
Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.
Difference between oximeter SpO2 and the corresponding SaO2 value
1 secondary outcome
Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia
Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.
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 31 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dina Gomaa, MSc principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia and Hyperoxia, run by University of Cincinnati 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 3 inclusion and 6 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 31 May 2025. 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?
Difference between SpO2 and the SaO2 value in all studied oximeters (time frame: At the time of arterial blood samples collection. Approximately 15 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 31 May 2025.