Skin Tone Measurement Method Investigation for Pulse Oximetry

Pulse Oximetry Clinical Trial

Official title:

Skin Tone Measurement Method Investigation for Pulse Oximetry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657665
• Other study ID #: ICBE-S-000880
• Status: Completed
• Start date: February 6, 2023
• Est. completion date: April 11, 2023

Study information

• Verified date: April 2023
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulse Oximetry

Intervention

Other:
• Observational measurements of skin tone
Objective and subjective skin tone measurements will be performed.

Locations

Country	Name	City	State
Netherlands	High Tech Campus	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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