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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT05185427
Study groupRoleWhat they receive
Participants with pulse oximetry readingsThe 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.

  1. 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.

  1. First posted11 Jan 2022
  2. Study start8 Mar 2022
  3. Primary completion8 Feb 2024
  4. Study completion8 Feb 2024

Resources

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)
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

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.

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