Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00807287
First received: December 10, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. In contrast in small uncontrolled trials different unguided techniques resulted in success rates up to 75%, only. In this prospective randomized trial the success rate of a correct jejunal placement with the endoscopic technique is compared with the unguided frictional technique. The investigators hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.


Condition Intervention
Critically Ill
Procedure: Jejunal tube placement using the unguided frictional method
Procedure: Jejunal tube placement using the endoscopic method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Success rate of correct jejunal placement [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay [ Time Frame: ICU-stay ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2005
Study Completion Date: April 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intubated and mechanically ventilated
  • Intolerance of intragastric enteral nutrition: defined as high gastric residual volumes (≥ 250ml / 24 hours) and/or repeated vomiting.

Exclusion:

  • Contraindication for enteral nutrition or gastric endoscopy
  • Previous upper gastrointestinal surgery
  • Signs of active gastric bleeding
  • Severe nasopharyngeal injuries or stenosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807287

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Holzinger, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Ulrike Holzinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00807287     History of Changes
Other Study ID Numbers: 517/2004
Study First Received: December 10, 2008
Last Updated: December 10, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
jejunal tube placement

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014