NCT00163813Unknown不适用
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
Bayside Health2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2005年9月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The amount of EN delivered during the Intensive Care Unit (ICU) stay
研究概览
简要总结
This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal [NJ] tube) and standard feeding in critical illness.
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
- 否
入选标准
- •ICU patients are eligible for enrolment if they meet all of the following:
- •Age > 18 years old
- •In ICU for < 48 hours prior to enrolment
- •Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for > 48 hours of mechanical ventilation
- •Receiving a continuous infusion of any one of:
- •morphine > 2 mg/hour,
- •fentanyl > 20 mcg/hour, or
- •pethidine > 20 mg/hour
- •Either a single GRV > 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage > 500 mls over 12 hours (whether receiving EN or not)
排除标准
- •Patients will be ineligible for enrolment if they meet any of the following:
- •Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy [Whipple's procedure])
- •Known gastric malignancy
- •Known oesophageal varices
- •Current admission for peptic ulceration
- •Current mechanical bowel obstruction
- •Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ
- •Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery)
- •Receiving nutritional support prior to ICU admission
- •Severe coagulopathy (defined by platelet count < 20 and/or international normalized ratio [INR] > 4.0)
结局指标
主要结局
The amount of EN delivered during the Intensive Care Unit (ICU) stay
次要结局
- Amount of EN delivered during the first 10 days of the study
- Daily cumulative proportion of EN delivered
- Ventilator-associated pneumonia rate
- Duration of mechanical ventilation
- Duration of hospitalisation
- Mortality at hospital discharge
- Success rate of placement into both the small bowel, generally, and the jejunum, specifically
- Complication rates (as compared to the nasogastric tube)
研究者
研究点 (2)
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