Gastric Feeding for the Prevention of Stroke-Associated Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Post-Pyloric Feeding, Gastric Feeding.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke
Overview
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.
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- Incidence of stroke-associated pneumonia within 7 days of onset [Time frame: 7 days of onset.]
Secondary outcome measures (7)
- Hospital length of stay [Time frame: From date of admission to date of discharge, assessed up to 28 days]
- 90-day modified Rankin Scale (mRS) score [Time frame: 90 days after randomization]
- Time from admission to achieving enteral nutrition target [Time frame: 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 [Time frame: Baseline and Day 14]
- Change from baseline in serum albumin level at Day 28 [Time frame: Baseline and Day 28]
- Change from baseline in white blood cell count at Day 14 [Time frame: Baseline and Day 14]
- Change from baseline in white blood cell count at Day 28 [Time frame: Baseline and Day 28]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Jinling Hospital, Medical School of Nanjing University, Nanjing — Nanjing
Identifiers
NCT: NCT07630090 · FEED-SAP