Clinical trial NCT06074406: Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation
Official title: Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Feasibility and Safety of a Low-field MRI
Acute Brain Injury
Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: Inclusion Criteria

* Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
* Ages 0-17 years
* Undergoing venovenous or venoarterial ECMO

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: Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
timeFrame: During Intervention, and immediately after intervention.
measure: Assessing the time needed to conduct a portable MRI with ECMO patients.
timeFrame: Pre intervention during patient prep, and during intervention, and immediately intervention.
measure: Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
timeFrame: Pre intervention, during intervention, and immediately after intervention.
measure: Determine the number of critical care therapies conducted during imaging studies.
timeFrame: Pre intervention during patient prep, during intervention, and immediately after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Jessica Wallisch, MD
role: PRINCIPAL_INVESTIGATOR
References: