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

Masimo

Status: Completed

Conditions: Surgery

Treatments: Device: O3 regional oximeter sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03123354

RAMA0003

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Test group

Experimental group

Description:

All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.

Treatment:

Device: O3 regional oximeter sensor