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Идёт набор NCT07176624

The PRE-VAIL Study

Без фазы С лечением ARDS (Moderate or Severe) Prone Position Enteral Nutrition Feeding Intensive Care Unit (ICU) Admission

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: Enteral nutrition is reduced before the prone position.
Кому может быть актуально
Состояния в реестре: ARDS (Moderate or Severe), Prone Position, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission. 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
Китай
Следующий шаг
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Официальное название

The Effect of Reducing Enteral Nutrition Before Prone Positioning on Clinical Outcomes in Mechanically Ventilated ARDS Patients: A Multicenter Randomized Controlled Trial (The PRE-VAIL Study)

Обзор

During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated acute respiratory distress syndrome (ARDS). The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced

Подробное описание

During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated ARDS.

The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced

Вмешательства

  • Процедура Enteral nutrition is reduced before the prone position
    Before the prone position, the gastric contents are aspirated with a syringe, and the dose of enteral nutrition reduction is determined based on the different amounts of gastric residue. If the residual volume in the stomach is less than 200ml, the enteral nutrition intake will be reduced by one third. Gastric residual volume 200-500ml: Reduce enteral nutrition by half. If the residual gastric volume is greater than 500ml: Stop enteral nutrition and consider post-pyloric feeding

Первичные конечные точки

  • The incidence of gastric retention during prone position [Срок оценки: Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU))]
Вторичные конечные точки (12)
  • The frequency of gastric retention during the prone position [Срок оценки: Acute stage of critical illness (within 7 days of ICU)]
  • The incidence of diarrhea during ICU stay [Срок оценки: Acute stage of critical illness (within 7 days of ICU)]
  • EN interruption rate [Срок оценки: Acute stage of critical illness (within 7 days of ICU)]
  • The incidence of Ventilator-associated pneumonia (VAP) among the participants [Срок оценки: During the length of stay in the ICU (from day 1 to a maximum of 28 days)]
  • Nutrition compliance rate [Срок оценки: The seventh day in the ICU]
  • Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning [Срок оценки: After each prone position during the ICU stay]
  • Length of stay in the ICU [Срок оценки: During the length of stay in the ICU (from day 1 to a maximum of 180 days)]
  • ICU mortality [Срок оценки: During the length of stay in the ICU (from day 1 to a maximum of 180 days)]
  • 28-day mortality [Срок оценки: Day 28 after being admitted to the ICU]
  • 90-day mortality [Срок оценки: The 90th day after being admitted to the ICU]
  • 180-day mortality [Срок оценки: Day 180 after being admitted to the ICU]
  • The incidence of gastric retention during ICU stay [Срок оценки: Within 1 to 7 days of hospitalization in the ICU]

Критерии участия

Критерии включения

  • Age ≥18 years old
  • Within 24 hours of admission to the ICU, one or more organ systems have failed (the Sequential Organ Failure Assessment (SOFA) score of any single organ system is ≥2)
  • Meet the diagnostic criteria for moderate/severe ARDS (even after optimizing the ventilation Settings, the oxygenation index is still < 150mmHg and PEEP is still ≥5 cm H2O)
  • It is expected to stay in the ICU for more than 48 hours

Критерии исключения

  • There are contraindications for the prone position
  • There are contraindications for EN, preventing the initiation of early EN (≤48 hours)
  • Expected to die within 48 hours
  • Pregnancy

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

Китай · 1 центр
  • The First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT07176624 · The PRE-VAIL Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗