Gastric Feeding for the Prevention of Stroke-Associated Pneumonia

ConditionStroke

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorJinling Hospital, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with pneumonia upon admission

High risk of gastrointestinal bleeding or perforation

Intestinal obstruction or gastrointestinal obstruction

Severe liver or kidney dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

Post-Pyloric Feeding
Procedure/Surgery
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
Procedure/Surgery
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.

Treatment groups

174 Participants

are divided into 2 treatment groups

Group A: Post-Pyloric Feeding GroupExperimental treatment 1 intervention

Group B: Gastric Feeding GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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

Other outcomes

Mortality within 28 days

Percentage of patients who die within 28 days post-randomization.

Time frame

28 days post-randomization.

Incidence of Gastrointestinal Complications

Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.

Time frame

28 days

Catheter-related Complications

Blockage, displacement, dislodgement

Time frame

28 days

Change from baseline in serum total protein level at Day 14

Serum total protein level will be measured via venous blood sample.

Time frame

Baseline and Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinling Hospital, China

Lead sponsor

Source ClinicalTrials.gov

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