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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245687
First Posted: October 28, 2005
Last Update Posted: March 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Thomas Jefferson University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00245687     History of Changes
Other Study ID Numbers: 05U.229
First Submitted: October 26, 2005
First Posted: October 28, 2005
Last Update Posted: March 14, 2014
Last Verified: March 2014

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