MedTrace Logo

In Vivo Pulse Oximeter Validation Study

NCT05873335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

COMBINATION_PRODUCT

Mixtures of nitrogen, air, and carbon dioxide

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

Sponsors & Collaborators

  • Gabi SmartCare

    lead INDUSTRY

Principal Investigators

  • Philip E Bickler, M.D., PhD. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-03-01
Completion
2023-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873335 on ClinicalTrials.gov