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Completed

NCT Number: NCT05469139

Assessing Brain Injury Using Portable Magnetic Resonance Imaging (MRI)

This study aims to assess the feasibility of assessing acute brain injury using a portable low field MRI in patients on ECMO.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

Extracorporeal membrane oxygenation (ECMO) is a life-saving therapy increasingly used in patients with refractory cardiopulmonary failure. The Extracorporeal Life Support Organization (ELSO) registry recently reported a 58% survival rate among patients who receive ECMO support, showing a significant mortality benefit in patients who would have not survived without ECMO. However, acute brain injury (ABI) is common in patients with ECMO support and leads to devastating consequences with significant morbidity and mortality. The mortality increases more than two-fold when ABI is present for both venoarterial (VA) and venovenous (VV) ECMO patients. The poor prognosis of ABI and neurological complications would suggest potential benefit from stringent and possibly even protocolized neurological monitoring to prevent or minimize further harm. This is particularly important as recent evidence promotes extracorporeal cardiopulmonary resuscitation (ECPR) as a rescue therapy for patients suffering from cardiac arrest of potentially reversible etiology. As clinical experience accumulates and ECPR becomes more widely used, neurological monitoring for complications and prognostication will be imperative for optimizing patient outcomes.

Although standardized neurological monitoring improves the detection of ABI, timely diagnosis and management for ABI in patients with ECMO support is still challenging due to the difficulty, impracticality, and danger of transporting ECMO patients to a CT scanner. Often, ECMO patients are unable to be transported to radiology suites because of the patients' persistent cardiopulmonary instability with multiple vasopressor requirements. In addition, even if head CT is performed in these patients, it is limited by poor sensitivity for detecting acute ischemic brain injury. Early neuroimaging is a key neuromonitoring aspect in the clinical evaluation of ABI. However, conventional magnetic resonance imaging (MRI) systems operate at high magnetic field strengths (1.5-3T) that require strict, access-controlled environments. Thus, limited access to timely brain scan with images of sufficient quality remains a significant barrier to effectively monitoring the occurrence and progression of ABI in ECMO.

Recent advances in low-field and portable MRI technology have enabled the acquisition of clinically meaningful imaging in the presence of ferromagnetic materials. A very low magnetic field strength, 64 magnetization transfer (mT), approximately 1/23 the field strength of a conventional MRI) provides a 5 Gauss line (safety zone) that is only about 2.5 feet from the center of the scanner. In a previous report, researchers were able to demonstrate the feasibility of a low-field, portable MRI in complex clinical care settings, such as intensive care units, without any adverse events or complications. In addition to reduced projectile motion, the use of low-field MRI may mitigate other safety concerns associated with high-field MRI, such as peripheral nerve stimulation (from gradients), a radiofrequency absorption and heating and acoustic noise.

The objective of this study is to assess acute brain injury with low-field, portable MRI of brain in patients with ECMO support.

This study will use the Hyperfine portable MRI machine which has FDA 510(k) clearance and is intended for use in intensive care units. The investigators' hypothesis is that low-field, portable MRI can detect ABI in patients with ECMO support, which may decrease the morbidity of patients on ECMO.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 and over
  • Patient supported with extracorporeal membrane oxygenation support (ECMO)
  • Legally authorized representative has provided written informed consent

Exclusion criteria

  • Patient has a contraindication for MRI such as:
  • Implants such as pacemaker, defibrillator, implanted insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, or programmable shunt
  • MRI incompatible surgical hardware such as staples, screws. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, cochlear implant
  • artificial hearts or heart valves with steel parts
  • metal fragments
  • shrapnel
  • tattoos near the eye
  • permanent make-up
  • steel implants
  • or other irremovable ferromagnetic objects
  • Patient weight is over 440 lbs (or 200kg)
  • Patient has Intra Aortic Balloon Pump (IABP), Implanted Ventricular Assist Device (VAD), or Percutaneous Ventricular Assist Device
  • Patient is pregnant

Treatment and study plan

Portable MRI acquisition

Diagnostic Test

Patients on ECMO will undergo a portable MRI of the brain

Primary outcomes

  1. Acute brain injury as assessed by head CT scan

    Time frame: 48 hours from ECMO initiation

    compare results of routinely performed head CT scans with results from a low field MRI to determine whether acute brain injury can be assessed using a low field MRI in patients with ECMO support.

Secondary outcomes

  1. prevalence of early acute brain injury as assessed by MRI scan

    Time frame: 24 hours from ECMO initiation

    use interpretations of low field MRI scans to determine the prevalence of early acute brain injury of patients with ECMO support at 24 hours

  2. Image Quality

    Time frame: 48 hours from ECMO initiation

    compare image quality of low field MRI scans with the image quality of routinely performed head CT scans to assess the image quality of MR images for infarcts and hemorrhages

  3. Impact of early detection as assessed by MRI

    Time frame: 48 hours from ECMO initiation

    assess anticoagulation strategies following low field MRI to determine the impact of early detection of acute brain injury on anticoagulation strategy

  4. Association of Transcranial doppler ultrasound with ischemic infarct

    Time frame: 48 hours from ECMO initiation

    measure transcranial doppler ultrasounds and correlate the findings with the results of low field MRI to assess for an association between Transcranial doppler ultrasound (TCD) microembolic signal (MES) and the presence of ischemic infarct on MRI.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Hyperfine

Registry information

Official study title

Assessing Brain Injury Using Portable Magnetic Resonance Imaging in Patients With Extracorporeal Membrane Oxygenation

Acronym: SAFE MRI

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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