Evaluation of Jejunal Placement of Enteral Feeding Tubes

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00500851
First received: July 12, 2007
Last updated: November 29, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention
Critical Illness
Tube Feeding
Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)
Device: Endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Success rate of jejunal placement [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).
Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)
Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
Other Name: CORTRAK
Active Comparator: 2
Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
Device: Endoscopy
Endoscopic placement of jejunal feeding tubes
Other Names:
  • Endoscopy (Olympus)
  • FREKA Trelumina

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00500851

Locations
Austria
Medical University Vienna, Department of Medicine III, ICU
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Holzinger, MD Medical University Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ulrike Holzinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00500851     History of Changes
Other Study ID Numbers: 138/2007
Study First Received: July 12, 2007
Last Updated: November 29, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
critical illness
enteral nutrition
gastrointestinal intubation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014