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

NCT ID: NCT00807287

Last Updated: 2008-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-04-30

Brief Summary

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.

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.

Conditions

Critically Ill

Keywords

jejunal tube placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Placement of jejunal feeding tube using the unguided frictional method

Group Type: EXPERIMENTAL

Jejunal tube placement using the unguided frictional method

Intervention Type: PROCEDURE

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.

2

Jejunal tube placement using the endoscopic method

Group Type: ACTIVE_COMPARATOR

Jejunal tube placement using the endoscopic method

Intervention Type: PROCEDURE

Jejunal feeding tubes are placed using endoscopy

Interventions

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.

Intervention Type: PROCEDURE

Jejunal tube placement using the endoscopic method

Jejunal feeding tubes are placed using endoscopy

Intervention Type: PROCEDURE

Other Intervention Names

Tiger Tube TM (Cook® Medical Inc., Bloomington, USA); Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Principal Investigators

Ulrike Holzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

517/2004

Identifier Type: -

Identifier Source: org_study_id