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

Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)

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

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Cerebral Oxygenation
• Intervention / Treatment: Other: Blood sample; Device: INVOS monitoring

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Washington University St. Louis
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Children's
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric; Subjects meeting inclusion criteria weighing between 4 and 40 kg	Other: Blood sample; During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization; Device: INVOS monitoring; During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.
Infant; Subjects meeting inclusion criteria weighing under 40 kg	Other: Blood sample; During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization; Device: INVOS monitoring; During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the root mean square	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	At the point of blood sampling during cardiac catheterization procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Director: Ami R Stuart, PhD, Principal Clinical Research Specialist

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; infant; cerebral oximetry
• Other Study ID Numbers: MDT23002INCATH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes