ECMO ABI Detection With Hyperfine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperfine.
- Who it may be relevant to
- Registry conditions: Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication, Hypoxia-Ischemia, Brain, Stroke, Acute. Basic parameters: 0 Days — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
Overview
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.
Interventions
- 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.
Primary outcome measures
- Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. [Time frame: Duration of ECMO treatment period, an average of <2 weeks]
Secondary outcome measures (1)
- 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. [Time frame: Duration of ECMO treatment period, an average of <2 weeks]
Eligibility criteria
Inclusion criteria
- 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Children's Mercy — Kansas City
Identifiers
NCT: NCT06469801 · STUDY00003208