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Evaluation of Jejunal Placement of Enteral Feeding Tubes
This study has been completed.
Study NCT00500851   Information provided by Medical University of Vienna
First Received: July 12, 2007   Last Updated: February 17, 2009   History of Changes

July 12, 2007
February 17, 2009
May 2007
January 2009   (final data collection date for primary outcome measure)
Success rate of jejunal placement [ Time Frame: 24h ] [ Designated as safety issue: No ]
success rate of jejunal placement [ Time Frame: 24h ]
Complete list of historical versions of study NCT00500851 on ClinicalTrials.gov Archive Site
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement [ Time Frame: ICU-stay ] [ Designated as safety issue: Yes ]
time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement [ Time Frame: ICU-stay ]
 
Evaluation of Jejunal Placement of Enteral Feeding Tubes
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)

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.

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.

 
Interventional
Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Critical Illness
  • Tube Feeding
  • Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)
  • Device: Endoscopy
  • Active Comparator: In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).
  • Active Comparator: Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
66
February 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00500851
Dr. Ulrike Holzinger, Medical University of Vienna
138/2007
Medical University of Vienna
 
Principal Investigator: Ulrike Holzinger, MD Medical University Vienna
Medical University of Vienna
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP