Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Regional Saturation of Oxygen (rSO2) Clinical Trial

Official title:

Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03828487
• Other study ID #: RAMA0004
• Status: Terminated
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: May 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Less than 10 kg

• Subjects less than or equal to 28 days old

Exclusion Criteria:

• Underdeveloped skin at sites of sensor placement

• Jaundice or bilirubin levels out of normal range

• Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study

• Subject deemed not eligible based on Principal Investigator's judgment

Related Conditions & MeSH terms

• Regional Saturation of Oxygen (rSO2)

Intervention

Device:
• Masimo O3 Neonatal Sensors
Regional Oximetry sensor for Neonates
• 510(k) cleared sensor
Cleared Regional Oximetry sensor for Neonates

Locations

Country	Name	City	State
United States	Stanford University Medical Center	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	Number of Participants With rSO2 Collected	In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.	Data collection period; alternating sensors every 5 minutes for up to 20 minutes.