CompletedNot Applicable

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

United States20 participantsStarted 2023-08-30

Plain-language summary

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

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: During Intervention, and immediately after intervention.

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

Timeframe: 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.

Timeframe: Pre intervention, during intervention, and immediately after intervention.

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

Timeframe: Pre intervention during patient prep, during intervention, and immediately after intervention.

Trial details

NCT IDNCT06074406

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Feasibility and Safety of a Low-field MRI trials