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Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

174

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002
        • Jinling Hospital, Medical School of Nanjing University, Nanjing
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Yahui Guo, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Procedure: 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
Aktiv komparator: 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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of stroke-associated pneumonia within 7 days of onset
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospital length of stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Day 28
White blood cell count will be measured via venous blood sample.
Baseline and Day 28

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality within 28 days
Tidsramme: 28 days post-randomization.
Percentage of patients who die within 28 days post-randomization.
28 days post-randomization.
Incidence of Gastrointestinal Complications
Tidsramme: 28 days
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
28 days
Catheter-related Complications
Tidsramme: 28 days
Blockage, displacement, dislodgement
28 days
Change from baseline in serum total protein level at Day 14
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Day 14
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 14
Change from baseline in interleukin-6 level at Day 28
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Day 28
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jinling Hospital, China

Efterforskere

  • Ledende efterforsker: Wusheng Zhu, MD, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

16. juni 2027

Studieafslutning (Anslået)

15. september 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FEED-SAP

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Patient information will be de-identified

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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