The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigment.

ABSTRACT:

Background

Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation.

Methods

Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry

SUBMITTER: Leeb G 

PROVIDER: S-EPMC10943300 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature