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

NCT00807287 | Completed

• 1 other identifier: 517/2004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

jejunal tube placement

Outcome Measures

Primary Outcomes (1)

• Success rate of correct jejunal placement

  24h

Secondary Outcomes (2)

• Duration of jejunal tube placement (initiation of jejunal tube placement till correct jejunal placement

  24h

• Adverse effects of tube placement and adverse side effects of jejunal tubes during the ICU stay

  ICU-stay

Study Arms (2)

1

EXPERIMENTAL

Placement of jejunal feeding tube using the unguided frictional method

Procedure: Jejunal tube placement using the unguided frictional method

2

ACTIVE COMPARATOR

Jejunal tube placement using the endoscopic method

Procedure: Jejunal tube placement using the endoscopic method

Interventions

Jejunal tube placement using the unguided frictional method 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.

Also known as: Tiger Tube TM (Cook® Medical Inc., Bloomington, USA)

1

Jejunal tube placement using the endoscopic method PROCEDURE

Jejunal feeding tubes are placed using endoscopy

Also known as: Freka® Trelumina (Fresenius Kabi AG, Bad Homburg, Germany)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindication for enteral nutrition or gastric endoscopy
• Previous upper gastrointestinal surgery
• Signs of active gastric bleeding
• Severe nasopharyngeal injuries or stenosis

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrike Holzinger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: February 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: April 1, 2006
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

AU (1)