Accuracy Performance Verification of the INVOS™ System in Pediatrics

Completed

• Conditions: Cerebral Oxygenation; Pediatric ALL
• Interventions: Other: Blood sample; Device: INVOS monitoring

• Registration Number: NCT05962905
• Lead Sponsor: Medtronic - MITG

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Study Start: 2023-11-16
• Primary Completion: 2024-11-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric	Blood sample	Subjects meeting inclusion criteria weighing between 4 and 40 kg
Pediatric	INVOS monitoring	Subjects meeting inclusion criteria weighing between 4 and 40 kg
Infant	Blood sample	Subjects meeting inclusion criteria weighing under 40 kg
Infant	INVOS monitoring	Subjects meeting inclusion criteria weighing under 40 kg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Washington University St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic Children's; 🇺🇸 Cleveland, Ohio, United States

Seattle Children's; 🇺🇸 Seattle, Washington, United States