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临床试验/NCT06469801
NCT06469801招募中不适用

Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
0 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • High risk participants include, but are not limited to:
  • Undergoing cardiac surgery
  • Congenital heart disease
  • Congenital diaphragmatic hernia
  • Refractory hypoxemic and/or hypercarbic respiratory failure
  • Vasoactive-refractory shock

排除标准

  • Pregnancy
  • Any patient who has a contraindication to having an MRI
  • 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

研究组 & 干预措施

Portable MRI Arm

Experimental

All subjects enrolled will be assigned to Arm 1

干预措施: Hyperfine (Device)

结局指标

主要结局

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

时间窗: 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).

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

时间窗: 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).

次要结局

  • 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.(Duration of ECMO treatment period, an average of <2 weeks)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica S. Wallisch

Pediatric Intensivist

Children's Mercy Hospital Kansas City

研究点 (2)

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