Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究者
Xinfeng Liu
Head of Neurology
Jinling Hospital, China