In Vivo Pulse Oximeter Validation Study

NCT05873335 | Completed Results FDA Device

• 1 other identifier: SpO2_3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Measure of Accuracy (ARMS [%])

  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.

  1 hour

Study Arms (1)

Healthy Adults

EXPERIMENTAL

Healthy adults

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

Interventions

Mixtures of nitrogen, air, and carbon dioxide COMBINATION_PRODUCT

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

Also known as: Radial arterial cannula

Healthy Adults

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Systemic illness
• Obesity

Sponsors & Collaborators

• Gabi SmartCare: lead

Study Sites (1)

Hypoxia Research Laboratory

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Air; Carbon Dioxide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Edouard Carton
• Organization: Gabi SmartCare

edouard.carton@gabismartcare.com

472537844

Study Officials

• Philip E Bickler, M.D., PhD.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 24, 2023
• Study Start: February 28, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)