RecruitingNot ApplicableNCT06469801

ECMO ABI Detection With Hyperfine

Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation

Sponsor

Children's Mercy Hospital Kansas City

Enrollment

30 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Acute brain injury Stroke, Acute Extracorporeal Membrane Oxygenation Complication Hypoxia-Ischemia, Brain

Summary

The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.

Eligibility

Min Age: 0 DaysMax Age: 17 Years

Inclusion Criteria9

Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
Ages 0-17 years
Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO
High risk participants include, but are not limited to:
Undergoing cardiac surgery
Congenital heart disease
Congenital diaphragmatic hernia
Refractory hypoxemic and/or hypercarbic respiratory failure
Vasoactive-refractory shock

Exclusion Criteria15

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

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Interventions

DEVICEHyperfine

Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients will also undergo a portable MRI within 24 hours of clinical head imaging, if applicable.