Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

Completed · Not applicable

Conditions studied: Surgery

In brief

The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.

Key facts

Study ID

NCT03123354

Run by

Masimo Corporation

People needed

44

Starts

2015-05-01

Expected to finish

2017-03-13

Last updated by the study team

2018-06-13

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease
• 1 day to less than 18 years of age
• Weight between 3.5 and 40 kg
• Parental or legal guardian consent and subject assent

You may not qualify if…

• Failure to obtain written consent
• Equal or more than 18 years in age
• Weight more than 40kg or less than 3.5kg
• Jaundice with bilirubin levels higher than the reference range
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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