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Идёт набор NCT06195345

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

— Наблюдательное HIE TBI (Traumatic Brain Injury) TBI Hemodynamic Instability

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: MR Imaging.
Кому может быть актуально
Состояния в реестре: HIE, TBI (Traumatic Brain Injury), TBI, Hemodynamic Instability. Базовые параметры: 1 Minute — 18 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 →

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Обзор

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

Подробное описание

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

Treatment:

Those who meet eligibility criteria, and who undergo the informed consent, will have their MRI extended by up to 7.5 minutes for up to 5 times. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, the additional images acquired will teach us about cerebral blood flow and cerebral venous oxygenation. Participants will also have non-invasive monitoring of their hematocrit immediately following the exam.

Safety Assessment:

The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel.

Efficacy Assessment:

Structural, and/or cerebral blood flow and/or metabolism MRIs will be collected from all subjects.

Вмешательства

  • Диагностический тест MR Imaging
    MR imaging pertaining to the patient and project (ICHOR 1)

Первичные конечные точки

  • Change in cerebral blood flow (ml blood/100g/min) [Срок оценки: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.]
  • Change in cerebral metabolic rate of oxygen (ml O2/100g/min) [Срок оценки: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.]

Критерии участия

Критерии включения

  • Individuals who are able to tolerate an MRI.
  • Are patients scheduled for a clinically indicated MRI.
  • Between birth and up to 18 years.

Критерии исключения

  • Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents)
  • Unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an MRI.
  • Preterm infants less than 25 weeks
  • Any patient who is clinically too unstable to extend their MRI by up-to 7.5 minutes.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06195345 · CHLA-18-00439 · 5K25HL153954-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗