Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05657665
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2022-12-12
Brief Title:
Skin Tone Measurement Method Investigation for Pulse Oximetry
Sponsor:
Philips Electronics Nederland BV acting through Philips CTO organization
Organization:
Philips Electronics Nederland BV acting through Philips CTO organization
Study Overview
Official Title:
Skin Tone Measurement Method Investigation for Pulse Oximetry
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N10 in total The study will be executed on the High-Tech Campus Eindhoven Netherlands and each participant will have 3 visits of approximately 15 to 2 hoursvisit
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 N10 in total The study will be executed on the High-Tech Campus Eindhoven Netherlands and each participant will have 3 visits of approximately 15 to 2 hoursvisit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None