An observational study in Hypoxemia, Hyperoxia and Pigment Skin, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by University of Cincinnati · Observational
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.
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 232 is above the median of 79 across 277 observational studies indexed under Hypoxia.
Browse Hypoxia studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
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ICU patients
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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.
Difference between SpO2 and the SaO2 value in all studied oximeters
Difference between oximeter SpO2 and the corresponding SaO2 value
Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.
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.
Time frame: At the time of arterial blood samples collection. Approximately 15 minutes.
Plan to share: Undecided
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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