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

Recruiting

• Conditions: Hyperoxia; Hypoxemia; Pigment Skin

• Registration Number: NCT05690269
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Study Start: 2023-02-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia	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.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States