Accuracy Performance Verification of the INVOS™ System in Pediatrics

NCT05962905 | Completed DMC FDA Device

• 1 other identifier: MDT23002INCATH
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cerebral Oxygenation; Pediatric ALL

Keywords

cerebral oximetry; pediatric; infant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pediatric

Subjects meeting inclusion criteria weighing between 4 and 40 kg

Other: Blood sample; Device: INVOS monitoring

Infant

Subjects meeting inclusion criteria weighing under 40 kg

Other: Blood sample; Device: INVOS monitoring

Interventions

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

Infant; Pediatric

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.

Infant; Pediatric

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (5)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Children's

Cleveland, Ohio, 44195, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ami R Stuart, PhD

  Principal Clinical Research Specialist

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 27, 2023
• Study Start: November 16, 2023
• Primary Completion: November 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)