Effectiveness of enteral feeding protocol on clinical outcomes in critically ill patients: a study protocol for before-and-after design
Effectiveness of enteral feeding protocol on clinical outcomes in critically ill patients: a study protocol for before-and-after design
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DOI：
10.21037/atm.2016.07.15
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发表时间：
2016-08-01
影响因子：
--
通讯作者：
Sun, Renhua
中科院分区：
文献类型：
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作者：
Zhang, Zhongheng;Li, Qian;Sun, Renhua
简介：肠内喂养是危重患者营养治疗的重要组成部分，喂养不足与不良后果相关。本文制定了肠内喂养方案，并计划进行前后比较试验，以探讨肠内喂养方案的实施是否能够改善临床结果。 方法与分析：该研究将在十个三级护理学术中心的重症监护病房（ICU）中进行。预计在 ICU 停留超过 3 天且需要肠内营养 (EN) 的危重患者可能符合资格。这是一项前后研究，包括三个阶段： 第一阶段是没有肠内喂养方案的时期；第二阶段包括为期四周的培训计划，最后阶段是在参与中心执行协议。我们计划总共招募 350 名患者，以提供 80% 的功效和 0.05 的错误率来检测死亡率降低 15%。主要结果是 28 天死亡率。 伦理与传播：进行研究的伦理批准已获得所有参与中心的批准。此外，研究结果将发表在同行评审的期刊上。
Introduction: Enteral feed is an important component of nutritional therapy in critically ill patients and underfeeding has been associated with adverse outcomes. The article developed an enteral feeding protocol and planed a before-and-after comparative trial to explore whether implementation of enteral feeding protocol was able to improve clinical outcomes.Methods and analysis: The study will be conducted in intensive care units (ICUs) of ten tertiary care academic centers. Critically ill patients expected to stay in ICU for over 3 days and require enteral nutrition (EN) were potentially eligible. This is a before-and-after study comprising three phases: The first phase is the period without enteral feeding protocol; the second phase involves four-week training program, and the last phase is to perform the protocol in participating centers. We plan to enroll a total of 350 patients to provide an 80% power and 0.05 error rate to detect a 15% reduction of mortality. The primary outcome is 28-day mortality.Ethics and dissemination: Ethical approval to conduct the research has been obtained from all participating centers. Additionally, the results will be published in peer-reviewed journal.