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

NCT03123354 | Completed Results FDA Device

• 1 other identifier: RAMA0003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  One visit; up to 4 hours

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: O3 regional oximeter sensor

Interventions

O3 regional oximeter sensor DEVICE

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

Test group

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease
• day to less than 18 years of age
• Weight between 3.5 and 40 kg
• Parental or legal guardian consent and subject assent

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

1 (949) 297-7416

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 21, 2017
• Study Start: May 1, 2015
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: June 13, 2018
• Results First Posted: June 13, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)