N/A
N=44
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03123354 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation of Percent rSO2 — 5.0 %rSO2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- O3 regional oximeter sensor (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation of Percent rSO2 |
5.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03123354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.