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Completed

NCT Number: NCT00500851

Evaluation of Jejunal Placement of Enteral Feeding Tubes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna, Department of Medicine III, ICU

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electromagnetic imaging for jejunal tube placement (CORTRAK)

Device

Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)

Other names: CORTRAK

Endoscopy

Device

Endoscopic placement of jejunal feeding tubes

Other names: Endoscopy (Olympus), FREKA Trelumina

Primary outcomes

  1. Success rate of jejunal placement

    Time frame: 24h

Secondary outcomes

  1. Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement

    Time frame: ICU-stay

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 13, 2007
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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