ECMO ABI-detektion med hyperfin
MRI ved sengekanten i lavt felt til påvisning af akut hjerneskade ved pædiatrisk ekstrakorporeal membraniltning
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Extracorporeal membrane oxygenation (ECMO) is frequently used to treat refractory cardiovascular and/or respiratory failure. As the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (ABI) in this population due to disease, patient, and treatment factors. This results in significant morbidity and mortality. Specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ECMO support, but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities (i.e. ultrasound [US], computed tomography [CT]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. The sensitivity of these modalities increases only when it is too late to effectively intervene. Standard magnetic resonance imaging (MRI) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices. Swoop (Hyperfine, Guilford, CT) is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI. This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible. A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility. Yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ECMO.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Maura Sien, MSML, CCRC
- Telefonnummer: 78311 8163028311
- E-mail: mesien@cmh.edu
Studiesteder
-
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Rekruttering
- Children's Mercy
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Kontakt:
- Maura Sien, RT(R), CCRC
- E-mail: mesien@cmh.edu
-
Kontakt:
- Jessica Wallisch, MD
- E-mail: jwallisch@cmh.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
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Ages 0-17 years
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Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO
• High risk participants include, but are not limited to:
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Undergoing cardiac surgery
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Congenital heart disease
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Congenital diaphragmatic hernia
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Refractory hypoxemic and/or hypercarbic respiratory failure
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Vasoactive-refractory shock
Exclusion Criteria:
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Pregnancy
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Any patient who has a contraindication to having an MRI
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Patients with a passive or active implant will:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Portable MRI Arm
All subjects enrolled will be assigned to Arm 1 |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
Tidsramme: Duration of ECMO treatment period, an average of <2 weeks
|
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). |
Duration of ECMO treatment period, an average of <2 weeks
|
|
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.
Tidsramme: Duration of ECMO treatment period, an average of <2 weeks
|
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. |
Duration of ECMO treatment period, an average of <2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess the association of clinical neurologic events to presence and type of imaging findings.
Tidsramme: From ICU admission to final neuroimaging during active study participation
|
Rates of seizures, pupillary changes, focal neurologic deficits, and neuromonitoring data will be correlated to neuroimaging diagnoses of acute brain injury. |
From ICU admission to final neuroimaging during active study participation
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jessica Wallisch, MD, Children's Mercy Kansas City
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Sår og skader
- Hjerneiskæmi
- Tegn og symptomer, luftveje
- Kraniocerebralt traume
- Traumer, nervesystemet
- Hypoxi, hjerne
- Hypoxi
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Slag
- Hjerneskader
- Hypoxi-iskæmi, hjerne
Andre undersøgelses-id-numre
- STUDY00003208
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
There is reasonable concern that sharing of IPD could allow patient re-identification given the single center study design involving a small and unique patient cohort. Given consideration for patient privacy, IPD will not be shared on open data platforms. De-identified IPD is available at reasonable request to the study PI with IRB approval and appropriate contracting.
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