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Evaluation of Jejunal Placement of Enteral Feeding Tubes

This study is currently recruiting participants.
Verified by Medical University of Vienna, October 2008

Sponsored by: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00500851
  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

MedlinePlus related topics:   Endoscopy   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)

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 ]

Estimated Enrollment:   66
Study Start Date:   May 2007
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
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)
2: Active Comparator
Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
Device: Endoscopy
Endoscopic placement of jejunal feeding tubes

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

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

Contacts
Contact: Ulrike Holzinger, MD     0043 1 40400 ext 4766     ulrike.holzinger@meduniwien.ac.at    
Contact: Christian Madl, MD     0043 1 40400 ext 4767     christian.madl@meduniwien.ac.at    

Locations
Austria
Medical University Vienna, Department of Medicine III, ICU     Recruiting
      Vienna, Austria, 1090
      Contact: Ulrike Holzinger, MD     0043 1 40400 ext 4766     ulrike.holzinger@meduniwien.ac.at    
      Contact: Christian Madl, MD     0043 1 40400 ext 4767     christian.madl@meduniwien.ac.at    
      Principal Investigator: Ulrike Holzinger, MD            

Sponsors and Collaborators
Medical University of Vienna

Investigators
Principal Investigator:     Ulrike Holzinger, MD     Medical University Vienna    
  More Information


Responsible Party:   Medical University of Vienna ( Dr. Ulrike Holzinger )
Study ID Numbers:   138/2007
First Received:   July 12, 2007
Last Updated:   November 3, 2008
ClinicalTrials.gov Identifier:   NCT00500851
Health Authority:   Austria: Ethikkommission

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

Study placed in the following topic categories:
Critical Illness

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 03, 2008




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