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

NCT05690269 | Completed

• 1 other identifier: HRP-503
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia; Hyperoxia; Pigment Skin

Keywords

SpO2, SaO2,Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Cincinnati: lead
• United States Air Force: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Hypoxia; Hyperoxia; Pigmentation Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes

Study Officials

• Dina Gomaa, MSc

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 19, 2023
• Study Start: February 27, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (1)