Skip to main content
OpenTrials
Completed

NCT Number: NCT05690269

Oximeters and Skin Pigment: 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SpO2 and SaO2 comparison

Device

Several pulse oximeter will be place on patients fingers a few minutes before arterial blood gases. SpO2 will be recorded during that time and up to 10 minutes.

Primary outcomes

  1. Difference between SpO2 and the SaO2 value in all studied oximeters

    Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.

    Difference between oximeter SpO2 and the corresponding SaO2 value

Secondary outcomes

  1. Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia

    Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.

    Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia (body temperature < 34 degrees C) and subjects requiring vasoactive infusions.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • United States Air Force

Registry information

Official study title

Impact of Skin Pigmentation on Accuracy of Pulse Oximetry

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2023
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.