Skin Tone Measurement Method Investigation for Pulse Oximetry

NCT ID: NCT05657665

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2023-04-11

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Observational measurements of skin tone

Objective and subjective skin tone measurements will be performed.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Electronics Nederland B.V. acting through Philips CTO organization

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

High Tech Campus

Eindhoven, , Netherlands

Countries

Netherlands

Other Identifiers

ICBE-S-000880

Identifier Type: -

Identifier Source: org_study_id