Accuracy Performance Verification of th… | Clinical Trial

Key information

Conditions

Cerebral Oxygenation Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Kansas City, Kansas City, Missouri, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
Known pregnancy

Treatment and study plan

blood sample

Other

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

INVOS monitoring

Device

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.

Primary outcomes

Accuracy of the root mean square

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: INCATH

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Jul 27, 2023
Registry last updated: May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed