Clinical trial NCT05962905: Accuracy Performance Verification of the INVOS™ System in Pediatrics
Official title: Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation
Pediatric ALL
Keywords: cerebral oximetry
pediatric
infant
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the root mean square
timeFrame: At the point of blood sampling during cardiac catheterization procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University St. Louis
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Children's
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Principal Clinical Research Specialist
name: Ami R Stuart, PhD
role: STUDY_DIRECTOR
References: