N/A Completed N=12 Other

In Vivo Pulse Oximeter Validation Study

Hypoxia

Source: ClinicalTrials.gov NCT05873335 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcomePrimary: Measure of Accuracy (ARMS [%]) — 2.95 Percentage

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Measure of Accuracy (ARMS [%])	2.95	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Systemic illness
Obesity

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05873335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.