ECMO ABI Detection With Hyperfine

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorChildren's Mercy Hospital Kansas City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Undergoing cardiac surgery

Disqualifiers

Pregnancy

Any patient who has a contraindication to having an MRI

First be reviewed on MRISafety.com to determine MR conditionality

If device is listed as Conditional or Unsafe for a 1.5T or a 3T, device will then be reviewed by MRI Safety Officer or MRI Physician Section chief to determine true conditionality for the portable MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperfine

    Device

    Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO. Patients will undergo imaging within 36 hours of ECMO initiation/cannulation. Patients that remain on ECMO will have repeat imaging at 72-120 hours of ECMO therapy and again weekly for the duration of their ECMO course. Patients may also undergo a portable MRI within 24 hours of clinical head imaging, if applicable.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Portable MRI ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.

Perform bedside MRI in pediatric ECMO patients treated in pediatric, cardiac, and neonatal intensive care units (ICUs) within 36 hours of cannulation. Determine rates of ABI (hypoxic, ischemic, cerebrovascular, and hemorrhagic injury along with assessment of cerebral edema and midline shift) in the pre- and peri-cannulation time periods. Correlate these imaging findings to rates of clinical neurological events (seizures, pupillary changes, focal neurological examination).

Time frame
Duration of ECMO treatment period, an average of <2 weeks
2

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.

Obtain bedside MRI in pediatric ECMO patients treated in pediatric, cardiac or neonatal ICUs at 72-120 hours post-cannulation and weekly until decannulation. Quantify and compare rates of ABI between bedside MRI and CT or US as read by blinded neuroradiologist.

Time frame
Duration of ECMO treatment period, an average of <2 weeks

Secondary outcomes

1

Assess the association of clinical neurologic events to presence and type of imaging findings.

Rates of seizures, pupillary changes, focal neurologic deficits, and neuromonitoring data will be correlated to neuroimaging diagnoses of acute brain injury.

Time frame
From ICU admission to final neuroimaging during active study participation

Other outcomes

Sponsors and contacts

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