Evaluation of Jejunal Placement of Enteral Feeding Tubes

Critical Illness Clinical Trial

Official title:

Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500851
• Other study ID #: 138/2007
• Status: Completed
• Phase: N/A
• First received: July 12, 2007
• Last updated: November 29, 2010
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Tube Feeding

Intervention

Device:
• Electromagnetic imaging for jejunal tube placement (CORTRAK)
Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
• Endoscopy
Endoscopic placement of jejunal feeding tubes

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Medicine III, ICU	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of jejunal placement		24h	No
Secondary	Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement		ICU-stay	Yes