Pulse Oximetry and Skin Pigmentation - Peds

NCT05185427 | Completed

• 1 other identifier: PEDS-2021-30541
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (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

  1 day

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Intensive Care Unit (ICU) patients, potentially including COVID-19 patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Gwenyth Fischer, MD

  University of Minnesota Medical School Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: March 8, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)