Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 174
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Xinfeng Liu
Head of Neurology
Jinling Hospital, China