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Starting soon Phase 4

Gastric Feeding for the Prevention of Stroke-Associated Pneumonia

NCT07630090 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-06-15
Last updated
2026-06-05

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Post-Pyloric FeedingGastric Feeding

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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

Primary outcome measure(s)

  • Incidence of stroke-associated pneumonia within 7 days of onset — 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.

Trial sites (1)

FacilityCityRegionStatus
Jinling Hospital, Medical School of Nanjing University, Nanjing Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07630090 on ClinicalTrials.gov ↗ ← All trials in China