Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Stopped early · Not applicable

Conditions studied: Regional Saturation of Oxygen (rSO2)

In brief

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

Key facts

Study ID

NCT03828487

Run by

Masimo Corporation

People needed

8

Starts

2018-12-19

Expected to finish

2019-06-14

Last updated by the study team

2021-06-07

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Less than 10 kg
• Subjects less than or equal to 28 days old

You may not qualify if…

• Underdeveloped skin at sites of sensor placement
• Jaundice or bilirubin levels out of normal range
• Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study
• Subject deemed not eligible based on Principal Investigator's judgment

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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