Accuracy Performance Verification of the INVOS™ System in Pediatrics
Completed
Conditions studied: Cerebral Oxygenation, Pediatric ALL
In brief
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
Key facts
- Study ID
- NCT05962905
- Run by
- Medtronic - MITG
- People needed
- 110
- Starts
- 2023-11-16
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2025-05-09
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Mercy Kansas City — Kansas City, Missouri, United States
- Washington University St. Louis — St Louis, Missouri, United States
- Duke University — Durham, North Carolina, United States
- Cleveland Clinic Children's — Cleveland, Ohio, United States
- Seattle Children's — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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