At a glance
ClinicalIndex Comparison RecordN/ACompleted· 44 enrolled
Drug / intervention
O3 regional oximeter sensordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization
In Brief
A clinical study evaluating O3 regional oximeter sensor for Surgery. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
Primary CompletionMar 2017
First PostedApr 2017
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartMay 1, 2015
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.2 years ago
Interventions
O3 regional oximeter sensordevice
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor