Clinical trial NCT06469801: ECMO ABI Detection with Hyperfine
Official title: Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Brain Injury
Extracorporeal Membrane Oxygenation Complication
Hypoxia-Ischemia, Brain
Stroke, Acute
Keywords: Pediatric
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
timeFrame: Duration of ECMO treatment period, an average of <2 weeks
Secondary outcomes:
measure: 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.
timeFrame: Duration of ECMO treatment period, an average of <2 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Jessica Wallisch, MD
role: PRINCIPAL_INVESTIGATOR
References: