Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
Glenn Whitman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01343316
First received: April 26, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Critical Illness
Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Benefits include shorter time to appropriate placement and quicker time to goal tube feed rate.


Enrollment: 21
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 26, 2011
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014