Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
Purpose
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.
Conditions
- Acute Brain Injury
- Hypoxia, Brain
- Ischemia, Brain
- Brain Injuries
- Trauma, Brain
- Stroke
Eligibility
- Eligible Ages
- Under 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit - Ages 0-17 years at study enrollment - Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
- Masking Description
- The neuroradiologists will be performing blinded assessments of the portable MRI images.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Portable MRI Arm |
All subjects enrolled with be assigned to Arm 1 |
|
Recruiting Locations
Kansas City, Missouri 64108
More Details
- Status
- Recruiting
- Sponsor
- Children's Mercy Hospital Kansas City
Detailed Description
Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others. Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by: 1. Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside. 2. Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam. 3. Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside. 4. Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.