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Идёт набор NCT06911736

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Без фазы С лечением Chronic Subdural Hematoma Trendelenburg Recurrence Mortality

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: Trendelenburg position.
Кому может быть актуально
Состояния в реестре: Chronic Subdural Hematoma, Trendelenburg, Recurrence, Mortality. 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
Колумбия
Следующий шаг
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Официальное название

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial

Обзор

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Подробное описание

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Вмешательства

  • Другое Trendelenburg position
    In addition to the management described above, the postoperative position was modified in the intervention group (trendelenburg). After admission to the hospital unit (general ward, special care, or intensive care unit), the patient's position was adjusted with a 30° leg elevation and a 10° downward head tilt. Proper positioning was verified with a goniometer. This position was maintained until the drains were removed, and the patient was then positioned according to usual care. If the patient d

Первичные конечные точки

  • Recurrence [Срок оценки: 3 months]
Вторичные конечные точки (1)
  • proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale. [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study

Критерии исключения

  • Pregnant or breastfeeding
  • Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
  • History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
  • Simultaneous participation in any other clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Колумбия · 3 центра
  • Clinica CES — Medellín
  • Hospital San Vicente Fundación — Medellín
  • Instituto Neurologico de Colombia — Medellín

Публикации

  • Hamou H, Alzaiyani M, Pjontek R, Kremer B, Albanna W, Ridwan H, Clusmann H, Hoellig A, Veldeman M. Risk factors of recurrence in chronic subdural hematoma and a proposed extended classification of internal architecture as a predictor of recurrence. Neurosurg Rev. 2022 Aug;45(4):2777-2786. doi: 10.1007/s10143-022-01790-8. Epub 2022 Apr 23. PMID 35461433

Идентификаторы

NCT: NCT06911736 · 102024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗