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临床试验/CTRI/2025/10/095923
CTRI/2025/10/095923尚未招募不适用

A randomized controlled trial to compare the efficacy and safety of continuous, intermittent and bolus enteral feeding in critically ill patients

Department of Critical Care Medicine1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2025年10月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
93
试验地点
1
主要终点
To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients.

研究概览

简要总结

Enteral nutrition (EN) delivers nutrition directly into the gastrointestinal tract and is preferred over parenteral nutrition (PN) due to its physiological benefits, preservation of gut integrity, lower complication risks, and immune advantages. It is widely used in acute, sub-acute, rehabilitation, and long-term care settings, and can be administered as continuous, cyclic, intermittent, or bolus feeding. Intermittent feeding, usually given over 20–60 minutes four to six times daily, is more physiological and allows patient mobility, but carries risks such as aspiration, diarrhea, and gastric distension. Bolus feeding, delivered rapidly via syringe or gravity drip three to six times daily, mimics normal meal patterns and enhances patient independence, though it may increase aspiration risk and cause osmotic diarrhea or delayed gastric emptying with certain formulas.

For critically ill patients, including those intubated, with poor glycemic control, receiving jejunal feeds, or unable to tolerate intermittent schedules, continuous EN via a pump or gravity bag at a set hourly rate is often preferred. Continuous feeding improves tolerance, reduces gastric residuals, and decreases aspiration risk but requires specialized equipment, restricts mobility, and increases costs. Comparative studies suggest continuous feeding offers better tolerance and lower gastric residuals than intermittent or bolus methods, though intermittent and bolus feeding are more physiological. However, no single study has compared all three methods directly, highlighting the need for further research.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients who are on tube feeding with normal gastric function admitted in ICU Who had given informed consent.

排除标准

  • Short bowel Severe Acute pancreatitis Post intestinal surgery Intestinal failure High/triple ionotropic support.
  • The patients who died or got discharged before 48 hours of initiation of feeding.

结局指标

主要结局

To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients.

时间窗: To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients at day1,day2,day3

次要结局

  • To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients.(To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients at day1, day2, day3)

研究者

发起方
Department of Critical Care Medicine
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aravind B Guledagudd

Bangalore Medical College and Research Institute

研究点 (1)

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