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Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation

Recruiting
- 17 years of age
Both
Phase N/A

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Overview

The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size

Eligibility

Inclusion Criteria

  • Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
  • Ages 0-17 years
  • Undergoing venovenous or venoarterial ECMO

Exclusion Criteria

  • Pregnancy
  • Active implants such as:
    • Pacemaker
    • Implanted defibrillator
    • Implanted insulin pump
    • Deep brain stimulator
    • Vagus nerve stimulator
    • Cochlear implant
    • Programmable shunt
  • MRI incompatible surgical hardware (e.g., staples, screws, etc.)
  • Metal-containing tattoos or permanent make-up on head or neck
  • Suspected metal in eye, e.g.,
  • Former or current welders, metal workers, or individuals with a metal injury
  • Metal shrapnel
  • Passive implants are considered MRI conditional

Study details

Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication

NCT06074406

Children's Mercy Hospital Kansas City

21 June 2024

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