Assessing Brain Injury Using Portable Magnetic Resonance Imaging (MRI) (SAFE MRI)

March 12, 2024 updated by: Johns Hopkins University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults patients on extracorporeal membrane oxygenation support (ECMO)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Portable MRI group
Patients on ECMO who undergo portable MRI to assess brain injury within 24-48 hours of ECMO initiation
Diagnostic test: Portable MRI acquisition
Patients on ECMO will undergo a portable MRI of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours from ECMO initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours from ECMO initiation
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
48 hours from ECMO initiation
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
48 hours from ECMO initiation
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.
48 hours from ECMO initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Hyperfine

Investigators

  • Principal Investigator: Sung Min Cho, DO, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00285716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical Study report will be available upon completion of the study analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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