Stroke
Conditions
Keywords
Gastric Feeding, NIHSS, severe stroke, Post-Pyloric Feeding, stroke-associated pneumonia
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.
Interventions
PROCEDUREPost-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
PROCEDUREGastric 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.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | From date of admission to date of discharge, assessed up to 28 days | Length of patients stay in the hospital |
| 90-day modified Rankin Scale (mRS) score | 90 days after randomization | The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment. |
| Time from admission to achieving enteral nutrition target | From date of admission until enteral nutrition target is achieved, assessed up to 28 days | Enteral nutrition target is set as 25-30kcal/kg. |
| Change from baseline in serum albumin level at Day 14 | Baseline and Day 14 | Serum albumin will be measured via venous blood sample. |
| Change from baseline in serum albumin level at Day 28 | Baseline and Day 28 | Serum albumin will be measured via venous blood sample |
| Change from baseline in white blood cell count at Day 14 | Baseline and Day 14 | White blood cell count will be measured via venous blood sample. |
| Change from baseline in white blood cell count at Day 28 | Baseline and Day 28 | White blood cell count will be measured via venous blood sample. |
Countries
China
Contacts
CONTACTYahui Guo, MD
CONTACTRui Liu, MD
PRINCIPAL_INVESTIGATORWusheng Zhu, MD
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed