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临床试验/CTRI/2025/09/094307
CTRI/2025/09/094307尚未招募不适用

Effect of intermittent versus bolus enteral feeding on feeding tolerance among critically ill patients at a tertiary care centre, Puducherry- A Randomized Controlled Trial

Intramural Research Fund Committee, JIPMER1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2025年9月17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
168
试验地点
1
主要终点
To assess the effectiveness of intermittent versus bolus feeding on enteral feeding tolerance of critically ill patient

研究概览

简要总结

This study is a randomized controlled trial on the effect of intermittent versus bolus enteral feeding on feeding tolerance among critically ill patients at JIPMER Puducherry. Patients who meet the inclusion criteria will be divided into two groups through block randomization.

Preparatory phase includes elevating the head of the bed at least 45 degrees to prevent aspiration and preparing articles required for intermittent and bolus feeding. Placement of tube will be confirmed by aspiration and air insufflation with stethoscope.

In intermittent feeding the targeted amount will be given through a feeding bag hung above the bed using a roller controller for one hour. In bolus feeding a syringe will be connected to the nasogastric tube and the feed will be given within 5 to 10 minutes followed by flushing with water.

Feeds will be given six times daily for five days. Gastric residual volume will be checked before every feed using a syringe. If residual volume is more than 50 percent of previous feed or above 250 ml the next feed will be withheld. If volume is below 250 ml it will be discarded and the next feed will be given.

Outcome measure will include gastric residual volume, abdominal distention, vomiting, diarrhea, constipation and achievement of targeted nutrition. Patients will be observed in semi fowlers or elevated position after feeding to reduce regurgitation and aspiration.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Mechanically ventilated patients
  • Patients admitted to the Critical Care ICU of JIPMER, Puducherry
  • Inability to swallow food orally and having indication for nasogastric tube feeding
  • Hemodynamically stable patients.

排除标准

  • Development of ability to eat orally during the study
  • Need for any urgent diagnostic or therapeutic procedure that requires nil per oral
  • Presence of fistula, obstruction and surgery of the gastrointestinal system.

结局指标

主要结局

To assess the effectiveness of intermittent versus bolus feeding on enteral feeding tolerance of critically ill patient

时间窗: 1 year

次要结局

  • - To assess the effectiveness of intermittent vs bolus enteral feeding methods i achieving targeted nutrition(- To associate the effectiveness of intermittent vs bolus feeding on enteral feeding tolerance with the clinical characteristics of the patients.)

研究者

发起方
Intramural Research Fund Committee, JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lakshmi Ramamoorthy

College of Nursing, JIMPER

研究点 (1)

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