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Completed

NCT Number: NCT06074406

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

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

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Key information

Conditions

Feasibility and Safety of a Low-field MRI Acute Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Extracorporeal Membrane Oxygenation Complication Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hyperfine

Device

Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO

Primary outcomes

  1. Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients

    Time frame: During Intervention, and immediately after intervention.

    Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).

  2. Assessing the time needed to conduct a portable MRI with ECMO patients.

    Time frame: Pre intervention during patient prep, and during intervention, and immediately intervention.

    The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.

  3. Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.

    Time frame: Pre intervention, during intervention, and immediately after intervention.

    The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.

  4. Determine the number of critical care therapies conducted during imaging studies.

    Time frame: Pre intervention during patient prep, during intervention, and immediately after intervention.

    Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Jan 8, 2026

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.

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