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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: O3 regional oximeter sensor

• Registration Number: NCT03123354
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2017-03-13
• Study Completion: 2017-03-13
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-21
• Results First Submitted: 2018-03-13
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-09
• Last Update Submitted: 2018-05-09
• Results First Posted: 2018-06-13
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor by Arms Calculation of Percent rSO2	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States