N/A Completed N=44 Other

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

Surgery

Source: ClinicalTrials.gov NCT03123354 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcomePrimary: Accuracy of Sensor by Arms Calculation of Percent rSO2 — 5.0 %rSO2

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of Sensor by Arms Calculation of Percent rSO2	5.0	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.