Набор скоро начнётся NCT07630090

Gastric Feeding for the Prevention of Stroke-Associated Pneumonia

Фаза IV С лечением Stroke

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: Post-Pyloric Feeding, Gastric Feeding.
Кому может быть актуально: Состояния в реестре: Stroke. Базовые параметры: Без ограничений · 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

Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke

Обзор

This randomized controlled trial aims to compare the effectiveness of early post-pyloric feeding versus gastric feeding in preventing SAP in patients with severe ischemic stroke. The main question to answer is whether post-pyloric feeding group is better than the gastric feeding group for preventing SAP.

Подробное описание

This study adopts a multicenter-center, randomized controlled, parallel-group, open-label trial design. Patients with severe ischemic stroke who meet the inclusion criteria will be randomly assigned to the post-pyloric feeding group (experimental group) or the gastric feeding group (control group). Both groups will receive standard stroke treatment and care. The primary outcome measure is the incidence of SAP, with a follow-up period of 90 days. The sample size is 174 cases, with 87 cases per group.

Вмешательства

Процедура Post-Pyloric Feeding
A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission. The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position. The insertion length will be approximately 75 cm. 200-500 ml of air and warm water will be injected into the stomach to open the pylorus. Gently, as the pylorus ope
Процедура Gastric Feeding
A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission. The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed. Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pum

Первичные конечные точки

Incidence of stroke-associated pneumonia within 7 days of onset [Срок оценки: 7 days of onset.]

Вторичные конечные точки (7)

Hospital length of stay [Срок оценки: From date of admission to date of discharge, assessed up to 28 days]
90-day modified Rankin Scale (mRS) score [Срок оценки: 90 days after randomization]
Time from admission to achieving enteral nutrition target [Срок оценки: From date of admission until enteral nutrition target is achieved, assessed up to 28 days]
Change from baseline in serum albumin level at Day 14 [Срок оценки: Baseline and Day 14]
Change from baseline in serum albumin level at Day 28 [Срок оценки: Baseline and Day 28]
Change from baseline in white blood cell count at Day 14 [Срок оценки: Baseline and Day 14]
Change from baseline in white blood cell count at Day 28 [Срок оценки: Baseline and Day 28]

Критерии участия

Критерии включения

Age ≥ 18 years
Diagnosis of severe ischemic stroke, with NIHSS score > 16 \[15-16\]
Confirmed dysphagia via swallowing assessment (Kubota Water Swallowing Test ≥ grade 3, or confirmed aspiration risk by FEES/VFSS)
Time from onset to enrollment ≤ 72 hours
Expected survival ≥ 7 days
Non-mechanically ventilated patients
Signed informed consent from patient or legal representative.