Меню
Набор скоро начнётся NCT07386834

Large-Scale Study of Oro-esophageal Feeding Versus Nasogastric Feeding for Swallowing Function and Airway Protection

Без фазы С лечением Dysphagia

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: Oro-esophageal Feeding, Nasogastric Feeding, Rehabilitation care.
Кому может быть актуально
Состояния в реестре: Dysphagia. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Effect of Oro-esophageal Versus Nasogastric Feeding for Stroke Patients With Dysphagia: A Multicenter Randomized Controlled Large-Scale Study

Обзор

This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.

Подробное описание

This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.

The intervention period will last for two weeks, with an additional four-week follow-up observation period. This is a multicenter study to be conducted across multiple hospitals.

Вмешательства

  • Пищевая добавка Oro-esophageal Feeding
    Medical staff inserts the tube slowly and smoothly into the upper esophagus, verifying the correct insertion depth by referencing the calibration marks on the tube wall. The distance from the incisors to the tube's tip should range from 22 to 25 cm. Following insertion, the distal end of the tube is submerged in a container of water, and the absence of continuous bubbling confirms successful intubation. Feeding is subsequently administered three times daily at a rate of 50 mL per minute, with a
  • Пищевая добавка Nasogastric Feeding
    The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient condition and relevant guidelines to reach the energy demand as 20-35 kcal/kg/day and daily protein demand of patients through the determination of 24-h urinary urea for both two groups.The intervention period lasts for a total of two weeks.
  • Поведенческое Rehabilitation care
    All patients will receive rehabilitation care according to the standard of care for the trial site hospital. All these interventions are performed in accordance with the Chinese Guidelines for Stroke Rehabilitation and the Chinese Guidelines for Dysphagia Rehabilitation. The intervention period lasts for a total of two weeks.

Первичные конечные точки

  • Dysphagia Outcome and Severity Scale [Срок оценки: Day 0 and day15]
Вторичные конечные точки (6)
  • Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale [Срок оценки: up to 2 weeks]
  • Time to oral intake [Срок оценки: up to 2 weeks]
  • Penetration-Aspiration Scale [Срок оценки: Day 0 and day15]
  • Murray Secretion Scale [Срок оценки: Day 0 and day15]
  • Yale Pharyngeal Residual Severity Rating Scale [Срок оценки: Day 0 and day15]
  • Aspiration [Срок оценки: up to 6 weeks]

Критерии участия

Критерии включения

  • Age>18 years.
  • First stroke
  • Disease duration less than one month.
  • Ischemic stroke.
  • Patients who need enteral feeding.
  • Dysphagia confirmed by imaging Study.
  • Clear consciousness.
  • Stable vital signs.
  • With informed consent and participants who understand and agree to comply with planned study procedures.

Критерии исключения

  • Dysphagia that might be caused by other diseases or structural abnormalities.
  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Contraindications for tube feeding.
  • Pregnancy or breast feeding.
  • Anticipated discharge from the hospital or transfer to another hospital within two week.

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Wang M, Xia C, Lu Y, Zeng H, Liu H, Zhao W, Wang L, Zeng X, Yang Y. Effects of oro-esophageal versus nasogastric feeding on dysphagia for ischemic stroke survivors: study protocol for a randomized controlled trial. Front Nutr. 2026 Apr 29;13:1830508. doi: 10.3389/fnut.2026.1830508. eCollection 2026. PMID 42137858

Идентификаторы

NCT: NCT07386834 · IOElastreport

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗