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临床试验/NCT06113393
NCT06113393尚未招募不适用

Comparison of the Effects of Different Gastric Residual Volume Thresholds for Holding Enteral Feeding on Nutritional Intake in Critically Ill Patients in Internal Medicine

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
230
试验地点
1
主要终点
Frequency of diet volume ratio

研究概览

简要总结

This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.

详细描述

Background: Malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. According to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (GRV). However, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. Clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. The aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine.

Objective

Increase the nutritional intake of critically ill patients in the Department of Internal Medicine by increasing the threshold for holding tube feeding.

Methods: This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart. The outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, Ventilator-associated pneumonia, length of intensive care unit(ICU) stay, changes in nutritional indicators, APACHE Ⅱ and Duration of parenteral nutrition use.

Expected result: The results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of GRV in medical ICU and inform future evidence-based practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients admitted to the internal medicine intensive care unit.
  • Patients receive enteral nutrition through a nasogastric tube.
  • Patients receiving continuous enteral feeding.

排除标准

  • Patients post-abdominal surgery.
  • Patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction).
  • Patients receiving palliative care with reduced enteral nutrition.

结局指标

主要结局

Frequency of diet volume ratio

时间窗: 1 day (Transfer from the Intensive Care Unit)

Incidence of gastrointestinal complications

时间窗: 1 day (Transfer from the Intensive Care Unit)

Abdominal distension, nausea, vomiting, diarrhea, constipation

次要结局

  • Days of ventilator use(A week(Transfer from the Intensive Care Unit))
  • Nutrition Risk Screening 2002(NRS2002)(1 day (Transfer from the Intensive Care Unit))
  • Acute Physiology and Chronic Health Evaluation score(1 day (Transfer from the Intensive Care Unit))
  • Length of stay in the intensive care unit(A week(Transfer from the Intensive Care Unit))
  • Days of parenteral nutrition use(A week(Transfer from the Intensive Care Unit))
  • Ventilator-associated pneumonia(1 day (Transfer from the Intensive Care Unit))
  • Albumin in g/dL(1 day (Transfer from the Intensive Care Unit))
  • C-reactive protein in mg/dl(1 day (Transfer from the Intensive Care Unit))
  • Body mass index(1 day (Transfer from the Intensive Care Unit))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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