このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年6月1日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

174

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Yahui Guo, MD
  • 電話番号：+86 13951834652
  • メール：1185626794@qq.com

研究連絡先のバックアップ

研究場所

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国、210002
        • Jinling Hospital, Medical School of Nanjing University, Nanjing
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Yahui Guo, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
手順：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
アクティブコンパレータ：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.
手順：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of stroke-associated pneumonia within 7 days of onset
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Hospital length of stay
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Day 28
White blood cell count will be measured via venous blood sample.
Baseline and Day 28

その他の成果指標

結果測定
メジャーの説明
時間枠
Mortality within 28 days
時間枠：28 days post-randomization.
Percentage of patients who die within 28 days post-randomization.
28 days post-randomization.
Incidence of Gastrointestinal Complications
時間枠：28 days
Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.
28 days
Catheter-related Complications
時間枠：28 days
Blockage, displacement, dislodgement
28 days
Change from baseline in serum total protein level at Day 14
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and Day 28
Body temperature will be recorded at 8:00 AM daily during the hospitalization.
Baseline and Day 28

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Jinling Hospital, China

捜査官

  • 主任研究者：Wusheng Zhu, MD、Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月15日

一次修了 (推定)

2027年6月16日

研究の完了 (推定)

2027年9月15日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FEED-SAP

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Patient information will be de-identified

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する