PDF(Pubmed)
Abstract：
UNASSIGNED: Enteral nutrition is beneficial for stroke patients with oral intake difficulties. However, it is time consuming and may interfere with routine medical care. Therefore, there is a clinical benefit if enteral nutrition can be safely administered in a short time. Although our retrospective study showed the safety of rapid administration, it remains unclear whether rapid administration of enteral nutrition is as safe as conventional administration.
UNASSIGNED: The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding.
UNASSIGNED: This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10-300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group).
UNASSIGNED: The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome.
UNASSIGNED: Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice.
UNASSIGNED: https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.
UNASSIGNED: The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding.
UNASSIGNED: This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10-300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group).
UNASSIGNED: The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome.
UNASSIGNED: Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice.
UNASSIGNED: https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.
摘要：
■肠内营养对口服摄入困难的中风患者有益。然而,这很耗时，可能会干扰常规医疗。因此,如果可以在短时间内安全地使用肠内营养，则有临床益处。尽管我们的回顾性研究显示了快速给药的安全性，目前尚不清楚肠内营养快速给药是否与常规给药一样安全.
■急性卒中患者快速肠内营养与常规给药的随机研究（快速EN试验）旨在阐明快速肠内营养与常规喂养相比的安全性。
■这是研究者发起的，多中心，prospective,随机化，开放标签，盲法终点临床试验.合格标准包括口服摄入困难的急性卒中患者，其定义为严重的意识改变（日本昏迷量表10-300）或改良的吞咽水测试<4。目标招募700名患者，其中350例患者在5分钟内以100mL的速度接受快速肠内营养（快速EN组），350例患者在30分钟内以100mL的速度接受常规肠内营养（常规EN组）。
■主要结果是快速EN组7天内呕吐或腹泻或肺炎的一种或多种并发症的发生率与常规EN组相比不差。次要结局是肠内营养7天内在肠内营养上花费的总时间，呕吐的发生率，腹泻和肺炎在3或7天内，和良好的临床结局率。
■由于以前没有报告关注管理速度，我们认为有必要证明快速管理的安全性。如果这项研究显示出积极的结果，它不仅使患者受益，也减轻了医疗负担。我们相信这项研究是新颖的，将在临床实践中有用。
■https://rctportal。尼夫.走吧。jp/s/detail/um?trial_id=UMIN000046610标识符UMIN000046610。
■急性卒中患者快速肠内营养与常规给药的随机研究（快速EN试验）旨在阐明快速肠内营养与常规喂养相比的安全性。
■这是研究者发起的，多中心，prospective,随机化，开放标签，盲法终点临床试验.合格标准包括口服摄入困难的急性卒中患者，其定义为严重的意识改变（日本昏迷量表10-300）或改良的吞咽水测试<4。目标招募700名患者，其中350例患者在5分钟内以100mL的速度接受快速肠内营养（快速EN组），350例患者在30分钟内以100mL的速度接受常规肠内营养（常规EN组）。
■主要结果是快速EN组7天内呕吐或腹泻或肺炎的一种或多种并发症的发生率与常规EN组相比不差。次要结局是肠内营养7天内在肠内营养上花费的总时间，呕吐的发生率，腹泻和肺炎在3或7天内，和良好的临床结局率。
■由于以前没有报告关注管理速度，我们认为有必要证明快速管理的安全性。如果这项研究显示出积极的结果，它不仅使患者受益，也减轻了医疗负担。我们相信这项研究是新颖的，将在临床实践中有用。
■https://rctportal。尼夫.走吧。jp/s/detail/um?trial_id=UMIN000046610标识符UMIN000046610。
