INCATH: Accuracy Performance Verification of the INVOS™ System in Pediatrics

Sponsor

Medtronic - MITG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05962905

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Oxygenation Pediatric ALL	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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	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.

Arm

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

Device: INVOS monitoring

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 21 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Under 21 years of age
Meets weight requirement for sensors under study
Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
Arterial and venous access as part of the planned catheterization procedure

Exclusion Criteria:

Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
A skin condition at the sensor site (e.g., rash, abrasion, laceration)
Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
A known structural brain lesion beneath the sensor
Known hemoglobinopathy
Inability to lie supine with neutral neck position during catheterization
Cerebrovascular disease
An emergent, life threatening condition impacting study conduct
Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
Currently receiving phototherapy for bilirubin
Arterial or venous anatomy that would preclude obtaining an accurate paired sample

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medtronic - MITG

Investigators

Study Director: Ami R Stuart, PhD, Principal Clinical Research Specialist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic - MITG

ClinicalTrials.gov Identifier:

NCT05962905

Other Study ID Numbers:

MDT23002INCATH

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Medtronic - MITG

cerebral oximetry

pediatric

infant

Study Results

No Results Posted as of Jul 27, 2023