Evaluation of Jejunal Placement of Enteral Feeding Tubes
Primary Purpose
Critical Illness, Tube Feeding
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Electromagnetic imaging for jejunal tube placement (CORTRAK)
Endoscopy
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring critical illness, enteral nutrition, gastrointestinal intubation
Eligibility 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
Sites / Locations
- Medical University Vienna, Department of Medicine III, ICU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).
Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
Outcomes
Primary Outcome Measures
Success rate of jejunal placement
Secondary Outcome Measures
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement
Full Information
NCT ID
NCT00500851
First Posted
July 12, 2007
Last Updated
November 29, 2010
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00500851
Brief Title
Evaluation of Jejunal Placement of Enteral Feeding Tubes
Official Title
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Tube Feeding
Keywords
critical illness, enteral nutrition, gastrointestinal intubation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).
Arm Title
2
Arm Type
Active Comparator
Arm Description
Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
Intervention Type
Device
Intervention Name(s)
Electromagnetic imaging for jejunal tube placement (CORTRAK)
Other Intervention Name(s)
CORTRAK
Intervention Description
Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
Intervention Type
Device
Intervention Name(s)
Endoscopy
Other Intervention Name(s)
Endoscopy (Olympus), FREKA Trelumina
Intervention Description
Endoscopic placement of jejunal feeding tubes
Primary Outcome Measure Information:
Title
Success rate of jejunal placement
Time Frame
24h
Secondary Outcome Measure Information:
Title
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement
Time Frame
ICU-stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Holzinger, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna, Department of Medicine III, ICU
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
21037470
Citation
Holzinger U, Brunner R, Miehsler W, Herkner H, Kitzberger R, Fuhrmann V, Metnitz PG, Kamolz LP, Madl C. Jejunal tube placement in critically ill patients: A prospective, randomized trial comparing the endoscopic technique with the electromagnetically visualized method. Crit Care Med. 2011 Jan;39(1):73-7. doi: 10.1097/CCM.0b013e3181fb7b5f.
Results Reference
derived
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Evaluation of Jejunal Placement of Enteral Feeding Tubes
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