Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT00807287|
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : December 11, 2008
|Condition or disease||Intervention/treatment|
|Critically Ill||Procedure: Jejunal tube placement using the unguided frictional method Procedure: Jejunal tube placement using the endoscopic method|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 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 Unguided, Frictional Method|
|Study Start Date :||February 2005|
|Primary Completion Date :||February 2006|
|Study Completion Date :||April 2006|
Placement of jejunal feeding tube using the unguided frictional method
Procedure: Jejunal tube placement using the unguided frictional method
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.
Other Name: Tiger Tube TM (Cook® Medical Inc., Bloomington, USA)
Active Comparator: 2
Jejunal tube placement using the endoscopic method
Procedure: Jejunal tube placement using the endoscopic method
Jejunal feeding tubes are placed using endoscopy
Other Name: Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)
- Success rate of correct jejunal placement [ Time Frame: 24h ]
- Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement [ Time Frame: 24h ]
- Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay [ Time Frame: ICU-stay ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807287
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Ulrike Holzinger, MD||Medical University of Vienna|