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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
174
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
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.
Jinling Hospital, Medical School of Nanjing University, Nanjing
Nanjing, Jiangsu, China
Incidence of stroke-associated pneumonia within 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.
Time frame: 7 days of onset.
Hospital length of stay
Length of patients stay in the hospital
Time frame: From date of admission to date of discharge, assessed up to 28 days
90-day modified Rankin Scale (mRS) score
The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.
Time frame: 90 days after randomization
Time from admission to achieving enteral nutrition target
Enteral nutrition target is set as 25-30kcal/kg.
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
Serum albumin will be measured via venous blood sample.
Time frame: Baseline and Day 14
Change from baseline in serum albumin level at Day 28
Serum albumin will be measured via venous blood sample
Time frame: Baseline and Day 28
Change from baseline in white blood cell count at Day 14
White blood cell count will be measured via venous blood sample.
Time frame: Baseline and Day 14
Change from baseline in white blood cell count at Day 28
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White blood cell count will be measured via venous blood sample.
Time frame: Baseline and Day 28