Rilevamento ABI ECMO con Hyperfine
MRI al posto letto a basso campo per il rilevamento di lesioni cerebrali acute nell'ossigenazione pediatrica extracorporea della membrana
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Maura Sien, MSML, CCRC
- Numero di telefono: 78311 8163028311
- Email: mesien@cmh.edu
Luoghi di studio
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Missouri
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Kansas City, Missouri, Stati Uniti, 64108
- Reclutamento
- Children's Mercy
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Contatto:
- Maura Sien, RT(R), CCRC
- Email: mesien@cmh.edu
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Contatto:
- Jessica Wallisch, MD
- Email: jwallisch@cmh.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
Lasso di tempo: Duration of ECMO treatment period, an average of <2 weeks
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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.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Assess the association of clinical neurologic events to presence and type of imaging findings.
Lasso di tempo: From ICU admission to final neuroimaging during active study participation
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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
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Jessica Wallisch, MD, Children's Mercy Kansas City
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Ferite e lesioni
- Ischemia cerebrale
- Segni e sintomi, respiratori
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Ipossia, cervello
- Ipossia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ictus
- Lesioni cerebrali
- Ipossia-ischemia, cervello
Altri numeri di identificazione dello studio
- STUDY00003208
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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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