Accuracy Performance Verification of the INVOS™ System in Pediatrics

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

Detailed Description
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The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients by comparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained through internal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.

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

Conditions
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Cerebral Oxygenation, Pediatric ALL

Intervention / Treatment
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* Other: Blood sample
* Device: INVOS monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under 21 years of age Meets weight requirement for sensors under study Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation Arterial and venous access as part of the planned catheterization procedure Exclusion Criteria: Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported] A skin condition at the sensor site (e.g., rash, abrasion, laceration) Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor A known structural brain lesion beneath the sensor Known hemoglobinopathy Inability to lie supine with neutral neck position during catheterization Cerebrovascular disease An emergent, life threatening condition impacting study conduct Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child Currently receiving phototherapy for bilirubin Arterial or venous anatomy that would preclude obtaining an accurate paired sample

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric<br>Subjects meeting inclusion criteria weighing between 4 and 40 kg | Other: Blood sample<br>* 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<br>Device: INVOS monitoring<br>* 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.<br>|
| Infant<br>Subjects meeting inclusion criteria weighing under 40 kg | Other: Blood sample<br>* 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<br>Device: INVOS monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At the point of blood sampling during cardiac catheterization procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral oximetry, pediatric, infant