Accuracy Performance Verification of the INVOS™ System in Pediatrics

Pediatric ALL Clinical Trial

— INCATH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05962905
• Other study ID #: MDT23002INCATH
• Status: Enrolling by invitation
• Start date: November 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients by comparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained through internal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Gender: All
• Age group: 0 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Oxygenation
• Pediatric ALL

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Cleveland Clinic Children's	Cleveland	Ohio
United States	Washington University St. Louis	Saint Louis	Missouri
United States	Seattle Children's	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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