In Vivo Pulse Oximeter Validation Study

NCT05873335 — Not applicable, Completed, 12 participants, Gabi SmartCare

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In Vivo Testing for SpO2 Accuracy on Healthy Adults Under Laboratory Conditions

Registry	NCT05873335
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	12 (Actual)
Sponsor	Gabi SmartCare (Industry)
Conditions	Hypoxia
Interventions	Mixtures of nitrogen, air, and carbon dioxide (Combination product)
Dates	start 2023-02-28, primary completion 2023-03-01, completion 2023-03-01, first posted 2023-05-24, last updated 2024-12-12
Locations	1 site in United States

-Summary

The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device

A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.

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+Arms and interventions

Arm	Type	Interventions	Description
Healthy Adults	Experimental	Combination Product: Mixtures of nitrogen, air, and carbon dioxide	Healthy adults

Mixtures of nitrogen, air, and carbon dioxide (Combination product), also known as Radial arterial cannula: Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015

+Outcome measures

Primary outcomes

Measure of Accuracy (ARMS [%]) [1 hour]: Arms, given in percentage or rms error, is the calculation of root mean square between SpO2 values from the subject device and the SaO2 from the Hemoximeter. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurmeent to a "rms error". It indicates how far (accurate) the provided value is from the reference used.

+Eligibility

Sex: All, ages: 21 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adult
* Normal hemoglobin levels (Hemoglobin > 10 g/dL)

Exclusion Criteria:

* Systemic illness
* Obesity

+Posted results

Participant flow

Milestone	Healthy Adults
Started	12
Completed	12
Not completed	0

Outcome results

Measure of Accuracy (ARMS [%]) (Primary), Number, Percentage: Healthy Adults 2.95

Adverse events

Time frame: 2 hours

Arm	Deaths	Serious adverse events	Other adverse events
Healthy Adults	0/12 (0.0%)	0/12 (0.0%)	0/12 (0.0%)

+Locations (1)

Facility	City	Country	Status
Hypoxia Research Laboratory	San Francisco, California	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2023-02-02)

+Investigators

Philip E Bickler, M.D., PhD., Principal investigator, University of California, San Francisco