Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
研究概览
简要总结
The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
- •Ages 0-17 years
- •Undergoing venovenous or venoarterial ECMO
排除标准
- •Pregnancy
- •Active implants such as:
- •Pacemaker
- •Implanted defibrillator
- •Implanted insulin pump
- •Deep brain stimulator
- •Vagus nerve stimulator
- •Cochlear implant
- •Programmable shunt
- •MRI incompatible surgical hardware (e.g., staples, screws, etc.)
- •Metal-containing tattoos or permanent make-up on head or neck
- •Suspected metal in eye, e.g.,
- •Former or current welders, metal workers, or individuals with a metal injury
- •Metal shrapnel
- •Passive implants are considered MRI conditional
研究组 & 干预措施
Portable MRI Arm
All subjects enrolled with be assigned to Arm 1
干预措施: Hyperfine (Device)
结局指标
主要结局
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
时间窗: Pre intervention, during intervention, and immediately after intervention.
The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
时间窗: During Intervention, and immediately after intervention.
Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).
Assessing the time needed to conduct a portable MRI with ECMO patients.
时间窗: Pre intervention during patient prep, and during intervention, and immediately intervention.
The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.
Determine the number of critical care therapies conducted during imaging studies.
时间窗: Pre intervention during patient prep, during intervention, and immediately after intervention.
Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).
次要结局
未报告次要终点
研究者
Jessica S. Wallisch
Pediatric Intensivist
Children's Mercy Hospital Kansas City