Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)
1 juin 2026 mis à jour par: Xinfeng Liu, Jinling Hospital, China
Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
174
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yahui Guo, MD
- Numéro de téléphone: +86 13951834652
- E-mail: 1185626794@qq.com
Sauvegarde des contacts de l'étude
- Nom: Rui Liu, MD
- Numéro de téléphone: +86 15005144515
- E-mail: liurui8616@163.com
Lieux d'étude
-
-
Jiangsu
-
Nanjing, Jiangsu, Chine, 210002
- Jinling Hospital, Medical School of Nanjing University, Nanjing
-
Contact:
- Yahui Guo, MD
- Numéro de téléphone: +86 13951834652
- E-mail: 1185626794@qq.com
-
Contact:
- Rui Liu, MD
- Numéro de téléphone: +86 15005144515
- E-mail: liurui8616@163.com
-
Sous-enquêteur:
- Yahui Guo, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Post-Pyloric Feeding Group
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 wi
|
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
|
|
Comparateur actif: Gastric Feeding Group
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of stroke-associated pneumonia within 7 days of onset
Délai: 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.
|
7 days of onset.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hospital length of stay
Délai: From date of admission to date of discharge, assessed up to 28 days
|
Length of patients stay in the hospital
|
From date of admission to date of discharge, assessed up to 28 days
|
|
90-day modified Rankin Scale (mRS) score
Délai: 90 days after randomization
|
The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.
|
90 days after randomization
|
|
Time from admission to achieving enteral nutrition target
Délai: From date of admission until enteral nutrition target is achieved, assessed up to 28 days
|
Enteral nutrition target is set as 25-30kcal/kg.
|
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
Délai: Baseline and Day 14
|
Serum albumin will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum albumin level at Day 28
Délai: Baseline and Day 28
|
Serum albumin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in white blood cell count at Day 14
Délai: Baseline and Day 14
|
White blood cell count will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in white blood cell count at Day 28
Délai: Baseline and Day 28
|
White blood cell count will be measured via venous blood sample.
|
Baseline and Day 28
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mortality within 28 days
Délai: 28 days post-randomization.
|
Percentage of patients who die within 28 days post-randomization.
|
28 days post-randomization.
|
|
Incidence of Gastrointestinal Complications
Délai: 28 days
|
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
|
28 days
|
|
Catheter-related Complications
Délai: 28 days
|
Blockage, displacement, dislodgement
|
28 days
|
|
Change from baseline in serum total protein level at Day 14
Délai: Baseline and Day 14
|
Serum total protein level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum prealbumin level at Day 14
Délai: Baseline and Day 14
|
Serum prealbumin level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum transferrin level at Day 14
Délai: Baseline and Day 14
|
Serum transferrin level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in serum total protein level at Day 28
Délai: Baseline and Day 28
|
Serum total protein will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in serum prealbumin level at Day 28
Délai: Baseline and Day 28
|
Serum prealbumin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in serum transferrin level at Day 28
Délai: Baseline and Day 28
|
Serum transferrin will be measured via venous blood sample
|
Baseline and Day 28
|
|
Change from baseline in C-reactive protein level at Day 14
Délai: Baseline and Day 14
|
C-reactive protein will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in interleukin-6 level at Day 14
Délai: Baseline and Day 14
|
Interleukin-6 level will be measured via venous blood sample.
|
Baseline and Day 14
|
|
Change from baseline in body temperature at Day 14
Délai: Baseline and Day 14
|
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
|
Baseline and Day 14
|
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Change from baseline in interleukin-6 level at Day 28
Délai: Baseline and Day 28
|
Interleukin-6 level will be measured via venous blood sample.
|
Baseline and Day 28
|
|
Change from baseline in C-reactive protein level at Day 28
Délai: Baseline and Day 28
|
C-reactive protein level will be measured via venous blood sample.
|
Baseline and Day 28
|
|
Change from baseline in body temperature at Day 28
Délai: Baseline and Day 28
|
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
|
Baseline and Day 28
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Wusheng Zhu, MD, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 juin 2026
Achèvement primaire (Estimé)
16 juin 2027
Achèvement de l'étude (Estimé)
15 septembre 2027
Dates d'inscription aux études
Première soumission
27 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
5 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FEED-SAP
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Patient information will be de-identified
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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