跳至主要内容
临床试验/NCT00500851
NCT00500851已完成不适用

Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Success rate of jejunal placement

研究概览

简要总结

The purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population. The investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method.

详细描述

Clinical studies have shown that up to 62,8% of patients receiving EN have gastrointestinal complications like high gastric residuals (≥200ml), vomiting, abdominal distension and regurgitation. These complications lead to interruptions of the EN, which result in a low caloric intake of the patient.

In order to avoid at least some of these complications the ACCP consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur. The Canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml, use of prokinetic agents and jejunal feeding for patients, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents). When gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents, small bowel feeding is the best method to nevertheless feed the patient enterally because it is associated with a significant decrease of reflux, a reduced risk of aspiration and an adequate caloric intake.

For small bowel feeding the placement of a jejunal feeding tube is necessary. There are several possibilities to place the tube in the small bowel. An excellent method still is endoscopy, which has a success rate up to 98% and moreover allows an evaluation of the upper GI-tract concerning pathologies. However, it is a rather time consuming procedure, which is of limited availability and requires trained staff. As more simple alternatives unguided tubes and their placement in the small bowel were tested and showed success rates up to 75% only. One of these alternatives is a jejunal feeding tube, which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor (CORTRAK™). The aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative ICU patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting)
  • Clinical indication of jejunal feeding

排除标准

  • Patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding

结局指标

主要结局

Success rate of jejunal placement

时间窗: 24h

次要结局

  • Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement(ICU-stay)

研究者

申办方类型
Other

研究点 (2)

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