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

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.

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Key information

Conditions

Surgery

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

O3 regional oximeter sensor

Device

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

Primary outcomes

Accuracy of Sensor by Arms Calculation of Percent rSO2

Time frame: One visit; up to 4 hours

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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 21, 2017
Registry last updated: Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed