Low-Field MRI for Pediatric ECMO Patients

Recruiting in Palo Alto (17 mi)

Overseen byJessica Wallisch, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Mercy Hospital Kansas City

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for children and teens (ages 0-17) in intensive care units who are on a life-support technique called ECMO. It's not for those who are pregnant, have devices like pacemakers or metal implants, tattoos with metal ink near the head or neck, suspected metal in their eye, or any MRI-incompatible surgical hardware.

Inclusion Criteria

I am 17 years old or younger.

Children who have been admitted to specific units at Children's Mercy Kansas City.

You are currently using a specific type of life support machine called ECMO.

Exclusion Criteria

Pregnancy

You have any active implanted devices like a pacemaker, defibrillator, insulin pump, or metal objects in your body.

Only implants that are safe to have during an MRI can be considered.

Participant Groups

The study tests the safety and feasibility of using a new low-field MRI machine right at the bedside of young patients on ECMO. The goal is to get clear images of the brain without moving these critically ill patients to standard imaging facilities.

1Treatment groups

Experimental Treatment

Group I: Portable MRI ArmExperimental Treatment1 Intervention

All subjects enrolled with be assigned to Arm 1