Pulse OximetryNCT05185427
Pulse Oximetry and Skin Pigmentation - Peds
An observational study of Pulse Oximetry, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators' study aims to study how melanin index (mx) affects the deviation between SpO2 and SaO2, which becomes generally greater as hypoxia increases. The studies reviewed grouped individuals by race or have assigned individuals into groups like "dark", "intermediate", or "light" to describe pigmentation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pulse Oximetry
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2022to 8 Feb 2024
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric Intensive Care Unit (ICU) patients, potentially including COVID-19 patients.
Who may be able to join
- Currently being cared for in the University of Minnesota Masonic Children's Hospital Intensive Care Unit (ICU)
- Already have an arterial line in place
- ICU staff state that it would be a good time to approach possible participants
Who cannot join
- If members of the research team are unable to access and measure with the Photovault the area that was measured via pulse oximetry by the care team
- Patients who do not have SpO2 or SaO2 measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Characterizing Error in Pulse Oximetry by Comparing Skin Pigmentation With Pulse Oximeter and Arterial Line Reading Deviations in Intensive Care Unit Pediatric Patients
The investigators' study aims to study how melanin index (mx) affects the deviation between SpO2 and SaO2, which becomes generally greater as hypoxia increases. The studies reviewed grouped individuals by race or have assigned individuals into groups like "dark", "intermediate", or "light" to describe pigmentation. Both of these methods are neither standardized nor objective, looking for race identifiers when it is more useful to be considering skin pigmentation identifiers. Skin pigmentation is a spectrum and it should be treated as such when trying to characterize relationships involving measurable factors such as melanin index.
The investigators will similarly measure the deviation between SpO2 and SaO2 however novel in that the investigators will quantitatively measure skin pigmentation via a light reflectance measurement device by Photovault.
Read the detailed description
Pulse oximetry is an essential tool within healthcare due to its impressive ability to detect low oxygen levels even before hypoxia manifests in a patient. Despite being a powerful tool, pulse oximetry has limitations. It is well known that nail polish or jaundice can interfere with pulse oximetry readings. This knowledge influences clinical practice in that providers are aware of the inaccurately low saturation readings associated with nail polish and jaundice. Alarmingly, several studies have reported that pulse oximetry also fails to read as accurately for patients who have greater levels of skin pigmentation.
One theory reported by Bickler et al. (2005) and Fiener et al. (2007) suggests that pulse oximetry accuracy decreases as hypoxia increases, where this deviation is further amplified in the presence of greater levels of skin pigmentation. Bickler et al. (2005) reported statistically significant differences in pulse oximeter readings on three different pulse oximeters. They found a small bias existed at blood oxygen saturations above 80% and increased as desaturation increased. Specifically, this bias over-estimated blood oxygenation in Black patients where Bickler et al. reported a bias as much as 8% at very low oxygen saturation. A similar trend has been reported by others. Clinically, a staggering number of COVID-19 patients fall victim to "silent" or "apathetic" hypoxemia, exhibiting minimal symptoms of concern upon presentation, but rapidly experience multi-organ failure and in the most unfortunate circumstance, death, in less than 48 hours. If not concerned at the moment, emergency departments suggest patients self-monitor their oxygen saturation at home and return for further evaluation if they record an oxygenation reading below the COVID-19 protocol threshold. What would be a difference of a couple percentage points of observed oxygenation levels with a pulse oximeter in patients with more skin pigmentation determines admission, access to the required care, and risks a delay in the necessary oxygen supplementation of patients. One paper has even suggested that clinicians should accept 95% oxygen saturation for Black patients as opposed to a threshold of 92% SpO2 to ensure proper oxygenation. In January 2021, the World Health Organization included the use of pulse oximeters to assess and identify patients that would require hospitalization for COVID-19. However, in February 2021, the FDA cautioned against using pulse oximeter oxygen readings to diagnose or rule out COVID-19 patients, questioning its reliability in clinically significant circumstances shortly after the New England Journal of Medicine reported that Black patients suffered from occult hypoxemia nearly three times as much than White patients.
The investigators' study aims to study how melanin index (mx) affects the deviation between SpO2 and SaO2, which becomes generally greater as hypoxia increases. The studies reviewed grouped individuals by race or have assigned individuals into groups like "dark", "intermediate", or "light" to describe pigmentation. Both of these methods are neither standardized nor objective, looking for race identifiers when it is more useful to be considering skin pigmentation identifiers. Skin pigmentation is a spectrum and it should be treated as such when trying to characterize relationships involving measurable factors such as melanin index.
The investigators will similarly measure the deviation between SpO2 and SaO2 however novel in that the investigators will quantitatively measure skin pigmentation via a light reflectance measurement device by Photovault.
- Conditions
- Pulse Oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with pulse oximetry readings | The research team will take a reflectance measurement on the same location that the most recent pulse oximetry measurement was taken. In addition, a reflectance measurement will be taken bilaterally for the nailbed, dorsal and ventral side of the digits, dorsal and ventral side of the hand, dorsal and ventral side of the forearm, lower leg, foot, and either side for the ear. The most recent pulse oximetry and arterial oxygen saturation readings will be accessed through the electronic medical records, those readings are generally conducted simultaneously and will provide comparison. The duration anticipated for an individual participant's participation is 1 day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between pulse oximetry saturation (SpO2) and arterial line saturation (SaO2)
The reflective index will be measured in percent reflectance via the Photovault. The SpO2 is measured via pulse oximetry by the healthcare team as percent oxygen saturation. The SaO2 is measured via Arterial Blood Gas, which is also measured by the healthcare team. SaO2 is also reported in percent oxygen saturation. The difference between SpO2 and SaO2 as a factor of the reflective index will be assessed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start8 Mar 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenyth Fischer, MD, Principal investigator, University of Minnesota Medical School Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185427
- Sponsor's protocol ID
- PEDS-2021-30541
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Error in Pulse Oximetry by Comparing Skin Pigmentation With Pulse Oximeter and Arterial Line Reading Deviations in Intensive Care Unit Pediatric Patients
- ClinicalTrials.gov ID
- NCT05185427
- Acronym / sponsor ID
- PEDS-2021-30541
- Conditions
- Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 11 Jan 2022 (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 investigators' study aims to study how melanin index (mx) affects the deviation between SpO2 and SaO2, which becomes generally greater as hypoxia increases. The studies reviewed grouped individuals by race or have assigned individuals into groups like "dark", "intermediate", or "light" to describe pigmentation. Both of these methods are neither standardized nor objective, looking for race identifiers when it is more useful to be considering skin pigmentation identifiers. Skin pigmentation is a spectrum and it should be treated as such when trying to characterize relationships involving measurable factors such as melanin index.
The investigators will similarly measure the deviation between SpO2 and SaO2 however novel in that the investigators will quantitatively measure skin pigmentation via a light reflectance measurement device by Photovault.
Detailed description
Pulse oximetry is an essential tool within healthcare due to its impressive ability to detect low oxygen levels even before hypoxia manifests in a patient. Despite being a powerful tool, pulse oximetry has limitations. It is well known that nail polish or jaundice can interfere with pulse oximetry readings. This knowledge influences clinical practice in that providers are aware of the inaccurately low saturation readings associated with nail polish and jaundice. Alarmingly, several studies have reported that pulse oximetry also fails to read as accurately for patients who have greater levels of skin pigmentation.
One theory reported by Bickler et al. (2005) and Fiener et al. (2007) suggests that pulse oximetry accuracy decreases as hypoxia increases, where this deviation is further amplified in the presence of greater levels of skin pigmentation. Bickler et al. (2005) reported statistically significant differences in pulse oximeter readings on three different pulse oximeters. They found a small bias existed at blood oxygen saturations above 80% and increased as desaturation increased. Specifically, this bias over-estimated blood oxygenation in Black patients where Bickler et al. reported a bias as much as 8% at very low oxygen saturation. A similar trend has been reported by others. Clinically, a staggering number of COVID-19 patients fall victim to "silent" or "apathetic" hypoxemia, exhibiting minimal symptoms of concern upon presentation, but rapidly experience multi-organ failure and in the most unfortunate circumstance, death, in less than 48 hours. If not concerned at the moment, emergency departments suggest patients self-monitor their oxygen saturation at home and return for further evaluation if they record an oxygenation reading below the COVID-19 protocol threshold. What would be a difference of a couple percentage points of observed oxygenation levels with a pulse oximeter in patients with more skin pigmentation determines admission, access to the required care, and risks a delay in the necessary oxygen supplementation of patients. One paper has even suggested that clinicians should accept 95% oxygen saturation for Black patients as opposed to a threshold of 92% SpO2 to ensure proper oxygenation. In January 2021, the World Health Organization included the use of pulse oximeters to assess and identify patients that would require hospitalization for COVID-19. However, in February 2021, the FDA cautioned against using pulse oximeter oxygen readings to diagnose or rule out COVID-19 patients, questioning its reliability in clinically significant circumstances shortly after the New England Journal of Medicine reported that Black patients suffered from occult hypoxemia nearly three times as much than White patients.
The investigators' study aims to study how melanin index (mx) affects the deviation between SpO2 and SaO2, which becomes generally greater as hypoxia increases. The studies reviewed grouped individuals by race or have assigned individuals into groups like "dark", "intermediate", or "light" to describe pigmentation. Both of these methods are neither standardized nor objective, looking for race identifiers when it is more useful to be considering skin pigmentation identifiers. Skin pigmentation is a spectrum and it should be treated as such when trying to characterize relationships involving measurable factors such as melanin index.
The investigators will similarly measure the deviation between SpO2 and SaO2 however novel in that the investigators will quantitatively measure skin pigmentation via a light reflectance measurement device by Photovault.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with pulse oximetry readings | – | –The research team will take a reflectance measurement on the same location that the most recent pulse oximetry measurement was taken. In addition, a reflectance measurement will be taken bilaterally for the nailbed, dorsal and ventral side of the digits, dorsal and ventral side of the hand, dorsal and ventral side of the forearm, lower leg, foot, and either side for the ear. The most recent pulse oximetry and arterial oxygen saturation readings will be accessed through the electronic medical records, those readings are generally conducted simultaneously and will provide comparison. The duration anticipated for an individual participant's participation is 1 day. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric Intensive Care Unit (ICU) patients, potentially including COVID-19 patients.
Key inclusion criteria (3 listed)
- Currently being cared for in the University of Minnesota Masonic Children's Hospital Intensive Care Unit (ICU)
- Already have an arterial line in place
- ICU staff state that it would be a good time to approach possible participants
Key exclusion criteria (2 listed)
- If members of the research team are unable to access and measure with the Photovault the area that was measured via pulse oximetry by the care team
- Patients who do not have SpO2 or SaO2 measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between pulse oximetry saturation (SpO2) and arterial line saturation (SaO2)
Time frame: 1 day
The reflective index will be measured in percent reflectance via the Photovault. The SpO2 is measured via pulse oximetry by the healthcare team as percent oxygen saturation. The SaO2 is measured via Arterial Blood Gas, which is also measured by the healthcare team. SaO2 is also reported in percent oxygen saturation. The difference between SpO2 and SaO2 as a factor of the reflective index will be assessed
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 10 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Pulse Oximetry
Not yet recruitingObservational study
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RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
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Temporal Dynamics of Peripheral SpO₂ During Reoxygenation
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Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit
Postoperative Hypoxemia
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Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
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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.
Gwenyth Fischer, MD principal investigator
University of Minnesota Medical School Department of Internal Medicine
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 Pulse Oximetry, run by University of Minnesota 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 2 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 10 Apr 2024. 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 pulse oximetry saturation (SpO2) and arterial line saturation (SaO2) (time frame: 1 day). 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 10 Apr 2024.