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

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00245687
First received: October 26, 2005
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
no Primary Disease; ICU Patient Who Require Enteral Nutrition
Device: Tiger Tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • success in placing feeding tube

Secondary Outcome Measures:
  • - rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin

Estimated Enrollment: 60
Study Start Date: June 2005
Study Completion Date: June 2007
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.

  Eligibility

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

Inclusion Criteria:

  • all ICU patients requiring enteral nutrition

Exclusion Criteria:

  • coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245687

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital - MRICU
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Paul Marik, MD Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245687     History of Changes
Other Study ID Numbers: 05U.229
Study First Received: October 26, 2005
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
feeding tube, nutrition, gastric, jejunal

ClinicalTrials.gov processed this record on August 18, 2014