Evaluation of Jejunal Placement of Enteral Feeding Tubes
|ClinicalTrials.gov Identifier: NCT00500851|
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : November 30, 2010
|Condition or disease||Intervention/treatment|
|Critical Illness Tube Feeding||Device: Electromagnetic imaging for jejunal tube placement (CORTRAK) Device: Endoscopy|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients: Endoscopic Versus Electromagnetic Method (CORTRAK™)|
|Study Start Date :||May 2007|
|Primary Completion Date :||January 2009|
|Study Completion Date :||February 2009|
Active Comparator: 1
In case of meeting clinical criteria for jejunal feeding, tubes are placed using CORTRAK (electromagnetic imaging).
Device: Electromagnetic imaging for jejunal tube placement (CORTRAK)
Jejunal feeding tubes are placed using electromagnetic imaging (CORTRAK)
Other Name: CORTRAK
Active Comparator: 2
Endoscopic placement of jejunal feeding tubes fulfilling clinical indication for jejunal feeding.
Endoscopic placement of jejunal feeding tubes
- Success rate of jejunal placement [ Time Frame: 24h ]
- Time from initiation of tube placement till correct jejunal placement, time of tube in correct jejunal position, complications of placement [ Time Frame: ICU-stay ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500851
|Medical University Vienna, Department of Medicine III, ICU|
|Vienna, Austria, 1090|
|Principal Investigator:||Ulrike Holzinger, MD||Medical University Vienna|