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

Children's Mercy Hospital Kansas City

Status: Completed

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

Treatments: Device: Hyperfine

Study type: Interventional

Funder types: Other

Identifiers

NCT06074406

STUDY00002824

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Portable MRI Arm

Experimental group

Description:

All subjects enrolled with be assigned to Arm 1

Treatment:

Device: Hyperfine