A Research Study to Test (2) Two Different Types of Feeding Tubes Used in the Intensive Care Unit

March 13, 2014 updated by: Thomas Jefferson University

A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube

The purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Enteral nutrition has many advantages for critically ill patients including lower incidence of infections and a reduced hospital stay, however it is controversial whether enteral feeding via small bowel feeding tubes offers an advantage over gastric feeding tubes in terms of reducing aspiration risk, improving feeding tolerance or ensuring quicker attainment of nutritional goals. The advantages of a small bowel feeding tube over a gastric feeding tube is thought to be related to its post pyloric position, however the insertion of small bowel feeding tubes is technically challenging (most studies report a success rate of 15-30%), can take time and has complications not unlike those of the gastric feeding tube. Our hypothesis is that the small bowel feeding tube offers an advantage to the gastric feeding tube due to its ability to achieve post pyloric placement. Specifically we chose to compare the standard gastric feeding tube (Dubhoff) to a small bowel feeding tube which offers the advantage of having alternating flaps which allows the gut to drag this tube into the small bowel.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital - MRICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all ICU patients requiring enteral nutrition

Exclusion Criteria:

  • coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
success in placing feeding tube

Secondary Outcome Measures

Outcome Measure
- rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Paul Marik, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05U.229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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