In Vivo Pulse Oximeter Validation Study

Gabi SmartCare

Status: Completed

Conditions: Hypoxia

Treatments: Combination Product: Mixtures of nitrogen, air, and carbon dioxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05873335

SpO2_3

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Systemic illness
• Obesity

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Healthy Adults

Experimental group

Description:

Healthy adults

Treatment:

Combination Product: Mixtures of nitrogen, air, and carbon dioxide