Accuracy Performance Verification of the INVOS™ System in Pediatrics

CompletedOBSERVATIONAL
Enrollment

110

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

April 30, 2025

Conditions
Cerebral OxygenationPediatric ALL
Interventions
OTHER

Blood sample

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

DEVICE

INVOS monitoring

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.

Trial Locations (5)

27710

Duke University, Durham

44195

Cleveland Clinic Children's, Cleveland

63110

Washington University St. Louis, St Louis

64108

Children's Mercy Kansas City, Kansas City

98105

Seattle Children's, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY