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Evaluation of Jejunal Placement of Enteral Feeding Tubes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500851
Enrollment
66
Registered
2007-07-13
Start date
2007-05-31
Completion date
2009-02-28
Last updated
2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Tube Feeding

Keywords

critical illness, enteral nutrition, gastrointestinal intubation

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.

Interventions

DEVICEElectromagnetic imaging for jejunal tube placement (CORTRAK)

Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)

DEVICEEndoscopy

Endoscopic placement of jejunal feeding tubes

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Success rate of jejunal placement24h

Secondary

MeasureTime frame
Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placementICU-stay

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026