Evaluation of Jejunal Placement of Enteral Feeding Tubes

NCT ID: NCT00500851

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Critical Illness Tube Feeding

Keywords

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critical illness enteral nutrition gastrointestinal intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).

Group Type ACTIVE_COMPARATOR

Electromagnetic imaging for jejunal tube placement (CORTRAK)

Intervention Type DEVICE

Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)

2

Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.

Group Type ACTIVE_COMPARATOR

Endoscopy

Intervention Type DEVICE

Endoscopic placement of jejunal feeding tubes

Interventions

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Electromagnetic imaging for jejunal tube placement (CORTRAK)

Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)

Intervention Type DEVICE

Endoscopy

Endoscopic placement of jejunal feeding tubes

Intervention Type DEVICE

Other Intervention Names

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CORTRAK Endoscopy (Olympus) FREKA Trelumina

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Ulrike Holzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

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Medical University Vienna, Department of Medicine III, ICU

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 21037470 (View on PubMed)

Other Identifiers

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138/2007

Identifier Type: -

Identifier Source: org_study_id