跳至主要内容
临床试验/NCT01137487
NCT01137487已完成不适用

Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study

Centre Hospitalier Departemental Vendee9 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
452
试验地点
9
主要终点
To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring

研究概览

简要总结

Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Treatment with invasive mechanical ventilation
  • Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
  • Age over 18 years
  • Informed consent

排除标准

  • Mechanical ventilation started more than 36 hours before institution of enteral feeding
  • Patients turned in the prone position at inclusion
  • Abdominal surgery within 1 month before inclusion
  • History of esophageal or gastric surgery
  • EN via a gastrostomy or a jejunostomy
  • Bleeding from esophagus, stomach or bowel
  • Moribund patient
  • Age less than 18 years
  • Pregnancy.
  • No informed consent.

研究组 & 干预措施

residual gastric volume

Other

干预措施: monitoring of residual gastric volume (Procedure)

residual gastric volume not monitored

Other

干预措施: not monitoring of residual gastric volume (Procedure)

结局指标

主要结局

To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring

时间窗: until weaning of mechanical ventilation (average : 14 days)

Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring

时间窗: until weaning of mechanical ventilation (average : 14 days)

次要结局

  • mortality rate(60 days)
  • vomiting rates(until weaning of mechanical ventilation (average : 14 days))
  • Mortality Rate(28 days)
  • Vomiting Rates(until weaning of mechanical ventilation (average : 14 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

Loading locations...

相似试验