Detecção de ECMO ABI com hiperfino
Ressonância magnética de baixo campo à beira do leito para detecção de lesão cerebral aguda em oxigenação por membrana extracorpórea pediátrica
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Maura Sien, MSML, CCRC
- Número de telefone: 78311 8163028311
- E-mail: mesien@cmh.edu
Locais de estudo
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Recrutamento
- Children's Mercy
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Contato:
- Maura Sien, RT(R), CCRC
- E-mail: mesien@cmh.edu
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Contato:
- Jessica Wallisch, MD
- E-mail: jwallisch@cmh.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.
Prazo: 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.
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assess the association of clinical neurologic events to presence and type of imaging findings.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jessica Wallisch, MD, Children's Mercy Kansas City
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Ferimentos e Lesões
- Isquemia Cerebral
- Sinais e Sintomas Respiratórios
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Hipóxia, Cérebro
- Hipóxia
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Derrame
- Lesões cerebrais
- Hipóxia-Isquemia, Cérebro
Outros números de identificação do estudo
- STUDY00003208
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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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