Меню
Идёт набор NCT07577336

Portable MRI for Pediatric Hypoxic Ischemic Brain Injury

Без фазы С лечением Acute Brain Injury Hypoxia, Brain Ischemia, Brain Brain Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Portable MRI, Scavenged Sample Collection.
Кому может быть актуально
Состояния в реестре: Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries. Базовые параметры: до 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury

Обзор

This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.

Подробное описание

Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.

Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:

1. Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside. 2. Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam. 3. Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside. 4. Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.

Вмешательства

  • Устройство Portable MRI
    Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT
  • Другое Scavenged Sample Collection
    Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.

Первичные конечные точки

  • Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries. [Срок оценки: During intensive care admittance, an average of 1 month]
Вторичные конечные точки (2)
  • Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries [Срок оценки: During intensive care admittance, an average of 1 month]
  • Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI. [Срок оценки: During intensive care admittance, an average of 1 month]

Критерии участия

Критерии включения

  • Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
  • Ages 0-17 years at study enrollment
  • Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Children's Mercy Hospital and Clinics — Kansas City

Идентификаторы

NCT: NCT07577336 · STUDY00003934

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗