NCT05962905

Accuracy Performance Verification of the INVOS™ System in Pediatrics

Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 0 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.

Detailed description

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.

Conditions

• Cerebral Oxygenation
• Pediatric ALL

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-11-30
• Completion: 2025-04-30
• First posted: 2023-07-27
• Last updated: 2025-05-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study