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Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01343316
Recruitment Status : Terminated (lack of funding)
First Posted : April 28, 2011
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the benefit of feeding critically-ill patients beyond the stomach (post-pyloric). Furthermore, because of the advent of two new post-pyloric feeding tubes (Tiger 2 and Syncro BlueTube) designed to improve post-pyloric placement, the investigators will be evaluating the benefits of those two tubes as well.

Condition or disease Intervention/treatment
Critical Illness Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients
Study Start Date : November 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013
Groups and Cohorts

Group/Cohort Intervention/treatment
Transgastric tube
Nasogastric (NG tube)
Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)
To determine the benefits of utilizing one type of transpyloric tube over another.
Other Names:
  • Nasogastric Tube (NG tube)
  • Tiger2
  • Syncro BlueTube
Transpyloric tube - Tiger2
Self-propelled by paristaltic waves of the stomach
Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)
To determine the benefits of utilizing one type of transpyloric tube over another.
Other Names:
  • Nasogastric Tube (NG tube)
  • Tiger2
  • Syncro BlueTube
Transpyloric tube - Syncro BlueTube
Magnetically placed
Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)
To determine the benefits of utilizing one type of transpyloric tube over another.
Other Names:
  • Nasogastric Tube (NG tube)
  • Tiger2
  • Syncro BlueTube


Outcome Measures

Primary Outcome Measures :
  1. To determine whether transpyloric feeds are superior to transgastric feeds with regard to ability to give calories and meet nutritional goals. [ Time Frame: one year ]
    To determine the time to goal calories. To determine the number and qualitative aspect of tracheal aspirations. To determine the time to initiate tube feeds once the decision has been made to place a tube, the number of x-rays required for placement, the time required for placement, the number of times tube needs to be replaced.


Secondary Outcome Measures :
  1. To determine the benefits of utilizing one type of transpyloric tube over another. One placed in the transpyloric position magnetically; the other propelled by peristalsis itself. [ Time Frame: one year ]
    Benefits include shorter time to appropriate placement and quicker time to goal tube feed rate.


Eligibility Criteria

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
Sampling Method:   Probability Sample
Study Population
Critically ill patients in the ICU setting
Criteria

Inclusion Criteria:

  • patients admitted to the ICU who are deemed by the attending critical care physician to warrant tube feeds and expected to receive tube feeds for more than three days
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): NCT01343316


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Glenn Whitman, MD Johns Hopkins University
More Information

Publications:
Responsible Party: Glenn Whitman, Associate Professor, Director of CVSICU and Adult Heart Transplant, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01343316     History of Changes
Other Study ID Numbers: NA_00041559
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Glenn Whitman, Johns Hopkins University:
Enteral Feeds
Supplemental Feeds
Transpyloric Tube
Nasogastric Tube

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes