Status:
COMPLETED
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Lead Sponsor:
Medtronic - MITG
Conditions:
Cerebral Oxygenation
Pediatric ALL
Eligibility:
All Genders
Up to 21 years
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 satur...
Eligibility Criteria
Inclusion
- 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
- 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
- Known pregnancy
Key Trial Info
Start Date :
November 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05962905
Start Date
November 16 2023
End Date
April 30 2025
Last Update
May 9 2025
Active Locations (5)
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1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
2
Washington University St. Louis
St Louis, Missouri, United States, 63110
3
Duke University
Durham, North Carolina, United States, 27710
4
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195