Oximeters and Skin Pigment: Impact of Skin Pigmentation on Accuracy of Pulse Oximetry

Impact of Skin Pigmentation on Accuracy of Pulse Oximetry

Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation.

This study aims to evaluate different FDA approved pulse oximeters (Nonin co-pilot, massimo Radical 7, Philips-standard of care monitor, innovo premium iP900BP, nellcor PM1000N, Nano100) with SaO2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.

Study Overview

• Status: Completed
• Conditions: Hypoxemia; Hyperoxia; Pigment Skin
• Intervention / Treatment: Device: SpO2 and SaO2 comparison

Detailed Description

The oximeters that will be evaluated are nonin co-pilot, massimo Radical 7, Philips (standard care), Innovo Premium iP900BP, nellcor PM1000N and USA medical supply Nano100. The sensors used will be reusable digital sensors for all oximeters. Oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. Due to the impact of the fingers used for SpO2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. Measurements will be made when the SpO2 with the usual oximeter is <97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. A set of measures that will include all the oximeters tested will be used. Once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. Then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the ICU. While the clinician takes the arterial blood gas, a picture will be simultaneously taken of the SpO2 readings shown by each oximeter, in addition to taking vital signs, O2 flow or FiO2.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

• ≥ 18 years old
• Patients admitted to the Intensive Care Unit
• Patient has arterial line

Exclusion Criteria:

• No signal with the oximeter
• Missing digits preventing application of all probes simultaneously
• No requirement for arterial blood gases
• Pigmented nails, fake nails, or nail polish
• Methemoglobinemia
• Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between SpO2 and the SaO2 value in all studied oximeters	Difference between oximeter SpO2 and the corresponding SaO2 value	At the time of arterial blood samples collection. Approximately 15 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia	Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia (body temperature < 34 degrees C) and subjects requiring vasoactive infusions.	At the time of arterial blood samples collection. Approximately 15 minutes.

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: United States Air Force
• Investigators: Principal Investigator: Dina Gomaa, MSc, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: SpO2, SaO2,Hypoxemia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Hyperoxia
• Other Study ID Numbers: HRP-503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No