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

Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury 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

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication; Acute Brain Injury; Feasibility and Safety of a Low-field MRI
• Intervention / Treatment: Device: Hyperfine

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maura Sien, RT(R); Phone Number: 8163018311; Email: mesien@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Kansas City
      • Contact: Maura Sien, RT(R); Phone Number: 816-301-8311; Email: mesien@cmh.edu
      • Principal Investigator: Jessica Wallisch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable MRI Arm; All subjects enrolled with be assigned to Arm 1	Device: Hyperfine; Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients	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).	During Intervention, and immediately after intervention.
Assessing the time needed to conduct a portable MRI with ECMO patients.	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.	Pre intervention during patient prep, and during intervention, and immediately intervention.
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.	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.	Pre intervention, during intervention, and immediately after intervention.
Determine the number of critical care therapies conducted during imaging studies.	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).	Pre intervention during patient prep, during intervention, and immediately after intervention.

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Jessica Wallisch, MD, Children's Mercy Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: STUDY00002824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes