Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.
Study Type
OBSERVATIONAL
Enrollment
110
During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization
During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.
Children's Mercy Kansas City
Kansas City, Missouri, United States
Washington University St. Louis
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic Children's
Cleveland, Ohio, United States
Accuracy of the root mean square
root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling
Time frame: At the point of blood sampling during cardiac catheterization procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seattle Children's
Seattle, Washington, United States