Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children (NCT03123354) | Clinical Trial Compass
CompletedNot Applicable
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
United States44 participantsStarted 2015-05-01
Plain-language summary
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.
Who can participate
Age range1 Day ā 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Accuracy of Sensor by Arms Calculation of Percent rSO2