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

Masimo Corporation44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

O3 regional oximeter sensorDEVICE

Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor

Eligibility

Sex: ALLMin age: 1 DayMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Accuracy of Sensor by Arms Calculation of Percent rSO2

The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.

Time frame: One visit; up to 4 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.