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

NCT ID: NCT05690269

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2025-03-31

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.

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.

Conditions

Hypoxemia; Hyperoxia; Pigment Skin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SpO2 and SaO2 comparison

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Air Force

FED

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Dina Gomaa

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina Gomaa, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

HRP-503

Identifier Type: -

Identifier Source: org_study_id