Cerebral Oxygenation, Pediatric ALL
Conditions
Keywords
cerebral oximetry, pediatric, infant
Brief 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.
Interventions
OTHERBlood 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
DEVICEINVOS 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.
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Under 21 years of age 2. Meets weight requirement for sensors under study 3. Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation 4. Arterial and venous access as part of the planned catheterization procedure
Exclusion criteria
1. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\] 2. A skin condition at the sensor site (e.g., rash, abrasion, laceration) 3. Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor 4. A known structural brain lesion beneath the sensor 5. Known hemoglobinopathy 6. Inability to lie supine with neutral neck position during catheterization 7. Cerebrovascular disease 8. An emergent, life threatening condition impacting study conduct 9. Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child 10. Currently receiving phototherapy for bilirubin 11. Arterial or venous anatomy that would preclude obtaining an accurate paired sample 12. Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the root mean square | At the point of blood sampling during cardiac catheterization procedure | 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 |
Countries
United States
Outcome results
None listed