NCT06469801

ECMO ABI Detection With Hyperfine

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 0 Days – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Extracorporeal membrane oxygenation (ECMO) is frequently used to treat refractory cardiovascular and/or respiratory failure. As the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (ABI) in this population due to disease, patient, and treatment factors. This results in significant morbidity and mortality. Specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ECMO support, but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities (i.e. ultrasound \[US\], computed tomography \[CT\]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. The sensitivity of these modalities increases only when it is too late to effectively intervene. Standard magnetic resonance imaging (MRI) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices. Swoop (Hyperfine, Guilford, CT) is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI. This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible. A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility. Yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ECMO.

Conditions

• Acute Brain Injury
• Extracorporeal Membrane Oxygenation Complication
• Hypoxia-Ischemia, Brain
• Stroke, Acute

Interventions

Type	Name	Description
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. 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.

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-06-30
• Completion: 2026-07-01
• First posted: 2024-06-24
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study