Post-Pyloric Feeding 和 Gastric Feeding 在中风-临床试验注册中心-ICH GCP

研究概览

地位

尚未招聘

条件

中风

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

174

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Yahui Guo, MD
电话号码：+86 13951834652
邮箱：1185626794@qq.com

研究联系人备份

姓名：Rui Liu, MD
电话号码：+86 15005144515
邮箱：liurui8616@163.com

学习地点

中国
- Jiangsu
  - Nanjing、Jiangsu、中国、210002
    - Jinling Hospital, Medical School of Nanjing University, Nanjing
    - 接触：
      
      Yahui Guo, MD
      
      电话号码：+86 13951834652
      
      邮箱：1185626794@qq.com
    - 接触：
      
      Rui Liu, MD
      
      电话号码：+86 15005144515
      
      邮箱：liurui8616@163.com
    - 副研究员：
      
      Yahui Guo, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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.

Exclusion Criteria:

Diagnosed with pneumonia upon admission
High risk of gastrointestinal bleeding or perforation
Intestinal obstruction or gastrointestinal obstruction
Severe liver or kidney dysfunction
Advanced malignant tumor
Pregnancy or breastfeeding
Refusal to participate in the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

2

武器和干预

参与者组/臂	干预/治疗
实验性的：Post-Pyloric Feeding Group 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 opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray 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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wi	程序：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 opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray 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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wil
有源比较器：Gastric Feeding Group 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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.	程序：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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.

参与者组/臂

干预/治疗

实验性的：Post-Pyloric Feeding Group

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 opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray 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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wi

程序：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 opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray 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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wil

有源比较器：Gastric Feeding Group

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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.

程序：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 pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Incidence of stroke-associated pneumonia within 7 days of onset 大体时间：7 days of onset.	The diagnostic criteria for SAP will follow the 2019 Chinese Expert Consensus on the Diagnosis and Treatment of Stroke-Associated Pneumonia.	7 days of onset.

次要结果测量

结果测量	措施说明	大体时间
Hospital length of stay 大体时间：From date of admission to date of discharge, assessed up to 28 days	Length of patients stay in the hospital	From date of admission to date of discharge, assessed up to 28 days
90-day modified Rankin Scale (mRS) score 大体时间：90 days after randomization	The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.	90 days after randomization
Time from admission to achieving enteral nutrition target 大体时间：From date of admission until enteral nutrition target is achieved, assessed up to 28 days	Enteral nutrition target is set as 25-30kcal/kg.	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 大体时间：Baseline and Day 14	Serum albumin will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum albumin level at Day 28 大体时间：Baseline and Day 28	Serum albumin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in white blood cell count at Day 14 大体时间：Baseline and Day 14	White blood cell count will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in white blood cell count at Day 28 大体时间：Baseline and Day 28	White blood cell count will be measured via venous blood sample.	Baseline and Day 28

其他结果措施

结果测量	措施说明	大体时间
Mortality within 28 days 大体时间：28 days post-randomization.	Percentage of patients who die within 28 days post-randomization.	28 days post-randomization.
Incidence of Gastrointestinal Complications 大体时间：28 days	Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.	28 days
Catheter-related Complications 大体时间：28 days	Blockage, displacement, dislodgement	28 days
Change from baseline in serum total protein level at Day 14 大体时间：Baseline and Day 14	Serum total protein level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum prealbumin level at Day 14 大体时间：Baseline and Day 14	Serum prealbumin level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum transferrin level at Day 14 大体时间：Baseline and Day 14	Serum transferrin level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum total protein level at Day 28 大体时间：Baseline and Day 28	Serum total protein will be measured via venous blood sample	Baseline and Day 28
Change from baseline in serum prealbumin level at Day 28 大体时间：Baseline and Day 28	Serum prealbumin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in serum transferrin level at Day 28 大体时间：Baseline and Day 28	Serum transferrin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in C-reactive protein level at Day 14 大体时间：Baseline and Day 14	C-reactive protein will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in interleukin-6 level at Day 14 大体时间：Baseline and Day 14	Interleukin-6 level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in body temperature at Day 14 大体时间：Baseline and Day 14	Body temperature will be recorded at 8:00 AM daily during the hospitalization.	Baseline and Day 14
Change from baseline in interleukin-6 level at Day 28 大体时间：Baseline and Day 28	Interleukin-6 level will be measured via venous blood sample.	Baseline and Day 28
Change from baseline in C-reactive protein level at Day 28 大体时间：Baseline and Day 28	C-reactive protein level will be measured via venous blood sample.	Baseline and Day 28
Change from baseline in body temperature at Day 28 大体时间：Baseline and Day 28	Body temperature will be recorded at 8:00 AM daily during the hospitalization.	Baseline and Day 28

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jinling Hospital, China

调查人员

首席研究员：Wusheng Zhu, MD、Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月15日

初级完成 (估计的)

2027年6月16日

研究完成 (估计的)

2027年9月15日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月1日

最后验证

2026年5月1日

Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)

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

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

研究联系人备份

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

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