Skin Tone Measurement Method Investigation for Pulse Oximetry

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.

Study Overview

• Status: Completed
• Conditions: Pulse Oximetry; Skin Types
• Intervention / Treatment: Other: Observational measurements of skin tone

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

• Study Contact: Name: Leonie van den Heuvel; Phone Number: 0031612318126; Email: leonie.van.den.heuvel@philips.com
• Study Contact Backup: Name: Willem Verkruijsse; Phone Number: 0031617418443; Email: wim.verkruijsse@philips.com

Study Locations

• Netherlands
  • Eindhoven, Netherlands
    • High Tech Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Healthy volunteers with Von Luschan scores <18 ('light skin' group) or > 25 ('dark skin' group.

Description

Inclusion Criteria:

1. Adults (18-65 years)
2. Fluent in either English or Dutch
3. Participants who are willing and able to provide informed consent themselves.
4. People with Von Luschan scores <18 ('light skin' group) or > 25 ('dark skin' group).

Exclusion Criteria:

1. Skin conditions that could potentially interfere with the measurements:

   • piercings/ink/henna tattoos that cover the left forearm, hands, fingers or forehead
   • vascular or pigmentary or renal psoriasis
   • epidermal bullosum
   • other diseases that affect the skin (tone) of the body

2. COVID-19 exclusion criteria*:

   • Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
   • Having been positively tested as infected with COVID-19 in the past 14 days
   • Travelled to or from high risk COVID-19 areas in the past 14 days
   • Been in contact with a (suspected) COVID-infected person in the past 14 days
3. Not being able to travel to Eindhoven 3 times, and/or not being able to comply with the study procedures
4. Sunbathing during the study duration or substantial sun exposure (due to holidays for example).
5. Known allergic reaction to facial make-up
6. Usage of tanning sprays/cremes

7. Wearing make-up during the study visits (mascara is allowed)

   • No testing will be performed in the study. Participants will be asked if they have been positively tested.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred skin PMM in the context of pulse-oximetry.	The primary objective is to complement a previous skin pigmentation study executed by Philips to gather missing information in order to form a well-founded recommendation on which is the preferred skin PPM in the context of pulse-oximetry.	10 months

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pulse oximetry; Skin types
• Other Study ID Numbers: ICBE-S-000880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan is to perform data analysis by Philips Research. Thereafter data will be shared (de-identified) in a seperate publication that can be accessed overall.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No