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Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients

Primary Purpose

Critically Ill

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Jejunal tube placement using the unguided frictional method
Jejunal tube placement using the endoscopic method
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill focused on measuring jejunal tube placement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intubated and mechanically ventilated
  • Intolerance of intragastric enteral nutrition: defined as high gastric residual volumes (≥ 250ml / 24 hours) and/or repeated vomiting.

Exclusion:

  • Contraindication for enteral nutrition or gastric endoscopy
  • Previous upper gastrointestinal surgery
  • Signs of active gastric bleeding
  • Severe nasopharyngeal injuries or stenosis

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Placement of jejunal feeding tube using the unguided frictional method

Jejunal tube placement using the endoscopic method

Outcomes

Primary Outcome Measures

Success rate of correct jejunal placement

Secondary Outcome Measures

Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement
Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay

Full Information

First Posted
December 10, 2008
Last Updated
December 10, 2008
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00807287
Brief Title
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients
Official Title
Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Unguided, Frictional Method
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. In contrast in small uncontrolled trials different unguided techniques resulted in success rates up to 75%, only. In this prospective randomized trial the success rate of a correct jejunal placement with the endoscopic technique is compared with the unguided frictional technique. The investigators hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.
Detailed Description
Artificial nutrition is an important link between the response to injury and recovery in critically ill patients admitted to an intensive care unit (ICU) Therefore artificial nutrition has become a part of ICU standard-therapy. Enteral nutrition (EN) has shown to be superior to total parenteral nutrition. Consequently, EN should be first choice in patients without contraindications for enteral feeding. However, although EN is beneficial for the patient it may also be associated with complications because of gastroduodenal motility disorders, which are common in critically ill patients, especially when they receive analgosedation. 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 American Society of Chest Physicians 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 patient, who are at high risk for intolerance of EN (on inotropes, sedatives, paralytic agents. Small bowel feeding is the best method to 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 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, which place themselves in the small bowel were tested and showed success rates up to 75% only. Different patient population and different severity of illness in ICU patients mislead to this developed difference in success rate. So far a prospective randomised trial comparing the endoscopic method versus the unguided frictional placement has not been studied. Therefore the aim of the study is the evaluation of the success rate of jejunal placement of these two different methods in a comparative ICU patient population. The secondary outcome parameters are: time to successful placement, time in place, costs and complications. We hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
jejunal tube placement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Placement of jejunal feeding tube using the unguided frictional method
Arm Title
2
Arm Type
Active Comparator
Arm Description
Jejunal tube placement using the endoscopic method
Intervention Type
Procedure
Intervention Name(s)
Jejunal tube placement using the unguided frictional method
Other Intervention Name(s)
Tiger Tube TM (Cook® Medical Inc., Bloomington, USA)
Intervention Description
The self-advancing nasal jejunal feeding tube has small alternating cilia-like plastic flaps to help to advance it into the small bowel via peristalsis. The tube is placed in the stomach (50-60 cm mark). Then the tube is left in place for 1 hour to allow the patient's peristalsis to advance the tube by catching its small plastic tabs. Thereafter, the tube is manually advanced 10 cm every hour until the 100 cm mark of length is reached. To improve peristalsis, 10mg metoclopramide i.v. and 200mg erythromycin i.v. 15 minutes before the procedure are administered.
Intervention Type
Procedure
Intervention Name(s)
Jejunal tube placement using the endoscopic method
Other Intervention Name(s)
Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)
Intervention Description
Jejunal feeding tubes are placed using endoscopy
Primary Outcome Measure Information:
Title
Success rate of correct jejunal placement
Time Frame
24h
Secondary Outcome Measure Information:
Title
Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement
Time Frame
24h
Title
Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay
Time Frame
ICU-stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated and mechanically ventilated Intolerance of intragastric enteral nutrition: defined as high gastric residual volumes (≥ 250ml / 24 hours) and/or repeated vomiting. Exclusion: Contraindication for enteral nutrition or gastric endoscopy Previous upper gastrointestinal surgery Signs of active gastric bleeding Severe nasopharyngeal injuries or stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Holzinger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients

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