N/A
N=12
In Vivo Pulse Oximeter Validation Study
Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT05873335 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Measure of Accuracy (ARMS [%]) — 2.95 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mixtures of nitrogen, air, and carbon dioxide (Combination_product)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Gabi SmartCare
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure of Accuracy (ARMS [%]) |
2.95 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy adult
- Normal hemoglobin levels (Hemoglobin > 10 g/dL)
Exclusion Criteria
- Systemic illness
- Obesity
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.