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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123354
• Other study ID #: RAMA0003
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: March 13, 2017

Study information

• Verified date: May 2018
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 13, 2017
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• O3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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