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Идёт набор NCT06466811

Prediction of Undesired Obstruction in External Ventricular Drains.

— Наблюдательное Intensive Care Unit Intraventricular Hemorrhage External Ventricular Drain

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: Patients of intensive care unit, Patients of surgical intensive care unit.
Кому может быть актуально
Состояния в реестре: Intensive Care Unit, Intraventricular Hemorrhage, External Ventricular Drain. Базовые параметры: от 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
Франция
Следующий шаг
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Официальное название

Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.

Обзор

Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated. Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.

Вмешательства

  • Другое Patients of intensive care unit
    Patients of intensive care unit having an EVD
  • Другое Patients of surgical intensive care unit
    Patients of surgical intensive care unit having an EVD.

Первичные конечные точки

  • Assessment of the predictive value of IVH severity for EVD obstruction [Срок оценки: From EVD insertion to removal up to 100 days.]
Вторичные конечные точки (9)
  • To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction. [Срок оценки: From EVD insertion to removal up to 100 days.]
  • Comparison of the performance of the Graeb-EVD score with that of the original Graeb score and the modified Graeb scores for the prediction of the occurrence of at least one episode of EVD obstruction. [Срок оценки: From EVD insertion to removal up to 100 days.]
  • Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days [Срок оценки: From EVD insertion to day 7.]
  • Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction. [Срок оценки: From EVD insertion to hospital discharge up to 12 months.]
  • Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt. [Срок оценки: From EVD insertion to hospital discharge up to 12 months.]
  • To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an unfavorable functional outcome on the day of hospital discharge and at 3±1 months. [Срок оценки: From EVD insertion to hospital discharge up to 12 months]
  • To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months. [Срок оценки: From EVD insertion to month 3 (± 1 month) after IVH.]
  • To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection. [Срок оценки: From EVD insertion to ICU discharge up to 6 months.]
  • To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt). [Срок оценки: From EVD insertion to ICU discharge up to 6 months.]

Критерии участия

Критерии включения

Patient older than 18 years old,

  • admitted to the ICU,
  • with first EVD inserted for less than 12 hours,
  • and brain imaging (CT or MRI) available in the timespan "24 hours before to 24 hours after" the EVD insertion.

Критерии исключения

  • EVD intentionally occluded immediately after its insertion,
  • purulent cerebrospinal fluid
  • Pregnant or breast-feeding patient
  • Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours
  • Patient with no health insurance
  • Patient under guardianship

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Nantes University Hospital — Nantes

Идентификаторы

NCT: NCT06466811 · RC24_0074

Первоисточники (государственные реестры)

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