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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Portable MRI Arm

All subjects enrolled with be assigned to Arm 1

Group Type EXPERIMENTAL

Hyperfine

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No