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Идёт набор NCT06241482

Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care

Без фазы С лечением Neurocritical Care Traumatic Brain Injury Cerebrovascular Disease Moderate or Severe Coma

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: Enhanced recovery after surgery, Conventional therapy.
Кому может быть актуально
Состояния в реестре: Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease, Moderate or Severe Coma. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients

Обзор

Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in neurosurgery, especially in clinical trials of neurocritical care patients. Therefore, the investigators attempt to conduct the study of ERAS in neurosurgical intensive patients using a series of optimized perioperative managements that have been verified to be effective by evidence-based medicine, and to evaluate the safety and effectiveness of ERAS in neurocritical care. The aim of this study is to explore the most suitable ERAS protocols to accelerate the postoperative rehabilitation process of neurocritical care patients, and to provide more evidence-based medicine for the effectiveness and safety of ERAS in neurosurgery.

Вмешательства

  • Процедура Enhanced recovery after surgery
    The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects: 1. Early assessment and treatment 2. Optimized anesthetic protocol 3. Reducing surgical stress 4. Multi-modal comprehensive monitoring 5. Comprehensive diagnosis and treatment in neurosurgical intensive care 6. Intensive early rehabilitation treatment
  • Процедура Conventional therapy
    Conventional therapy in neurocritical care.

Первичные конечные точки

  • Clinical prognosis [Срок оценки: One month, three and six months after injury or attack]
  • Neurological function assessment [Срок оценки: One month, three and six months after injury or attack]
Вторичные конечные точки (1)
  • Neuroimaging evaluation [Срок оценки: One week, two weeks after surgery; one month, three and six months after injury or attack]

Критерии участия

Критерии включения

  • Age 18-75 years old
  • Patients with moderate or severe acute traumatic brain injury or cerebrovascular disease requiring neurosurgical intensive care treatment
  • Hospitalization time ≥ 1 week
  • The guardian is able to understand and actively cooperate in completing the project
  • The guardian signs an informed consent form

Критерии исключения

  • Patients undergoing non-surgical treatment
  • Patients diagnosed as brain death within the first 24 hours after admission to NICU
  • Patients undergoing cardiopulmonary resuscitation, maintenance dialysis, end-stage tumors, and disseminated cancer
  • Patients who withdraw treatment during hospitalization or are discharged automatically
  • Patients who underwent unplanned secondary surgery during the research process
  • Individuals who cannot be followed up during the research process

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai 6th People's Hospital — Шанхай

Идентификаторы

NCT: NCT06241482 · 2024-179

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗