NCT05657665

Skin Tone Measurement Method Investigation for Pulse Oximetry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: —

Summary

The primary objective is to gather missing information in order to form a well-founded recommendation on which is the preferred skin pigmentation measurement (PPM) methods in the context of pulse-oximetry.

Detailed description

Skin tone bias in pulse-oximetry (SpO2) needs to be addressed urgently. While skin pigmentation is a prime candidate for the root cause of skin tone bias in SpO2, more research is needed. F A solid comparison and recommendation requires evaluation of several additional aspects that affect accuracy, precision, and reproducibility of the PMMs. Briefly, these additional aspects that are evaluated in this study are listed below: * operator bias * impact of operator color blindness * probe pressure * probe aperture size * device stability * impact of blood on pigmentation measurement * feasibility of skin tone measurement on sides of fingers * intra-operator variability PMMs included in this study are: Subjective color matching methods by using: 1. Von Luschan color scale 2. Fitzpatrick color scale 3. Pantone color scale Objective probe-based measurements by using: 1. Konica Minolta CM700d (reflectance spectrometer) 2. Mx18 (erythema-melanin meter) 3. SPA99 (erythema-melanin meter) Measurements will be performed on 5 relatively light skinned, and 5 relatively dark skinned volunteers (N=10 in total\*). The study will be executed on the High-Tech Campus Eindhoven (Netherlands) and each participant will have 3 visits of approximately 1.5 to 2 hours/visit.

Conditions

• Skin Types
• Pulse Oximetry

Interventions

Type	Name	Description
OTHER	Observational measurements of skin tone	Objective and subjective skin tone measurements will be performed.

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-04-11
• Completion: 2023-04-11
• First posted: 2022-12-20
• Last updated: 2023-04-12

Locations

1 site across 1 country: Netherlands