Clinical trial · Observational
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
NCT05962905CI-TRIAL-00089477INCATHcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Oxygenation | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
| INVOS monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pediatric
- description
- Subjects meeting inclusion criteria weighing between 4 and 40 kg
- interventionNames
- Other: Blood sample
- Device: INVOS monitoring
- label
- Infant
- description
- Subjects meeting inclusion criteria weighing under 40 kg
- interventionNames
- Other: Blood sample
- Device: INVOS monitoring
Primary outcomes (1)
- measure
- Accuracy of the root mean square
- timeFrame
- At the point of blood sampling during cardiac catheterization procedure
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.