Accuracy Performance Verification of the INVOS™ System in Pediatrics (INCATH)

Medtronic

Status: Completed

Conditions: Pediatric ALL; Cerebral Oxygenation

Treatments: Other: Blood sample; Device: INVOS monitoring

Study type: Observational

Funder types: Industry

Identifiers

NCT05962905

MDT23002INCATH

Details and patient eligibility

About

Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Pediatric

Description:

Subjects meeting inclusion criteria weighing between 4 and 40 kg

Treatment:

Device: INVOS monitoring

Other: Blood sample

Infant

Description:

Subjects meeting inclusion criteria weighing under 40 kg

Treatment:

Device: INVOS monitoring

Other: Blood sample