Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

Not Applicable

Terminated

• Conditions: Regional Saturation of Oxygen (rSO2)
• Interventions: Device: Masimo O3 Neonatal Sensors; Device: 510(k) cleared sensor

• Registration Number: NCT03828487
• Lead Sponsor: Masimo Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Primary Completion: 2019-06-14
• Study Completion: 2019-06-14
• Results First Submitted: 2020-05-06
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-06-07
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonatal Test group	510(k) cleared sensor	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.
Neonatal Test group	Masimo O3 Neonatal Sensors	Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.

Primary Outcome Measures

Name	Time	Method
Number of Participants With rSO2 Collected	Data collection period; alternating sensors every 5 minutes for up to 20 minutes.	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.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States