Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Johns Hopkins University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01343316

First received: April 26, 2011

Last updated: April 27, 2011

Last verified: January 2011

History of Changes

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 paristalsis 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.

Estimated Enrollment:	150
Study Start Date:	November 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343316

Locations

United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Glenn Whitman, MD 410-955-3285 gwhitman@jhmi.edu
Contact: Kimberly Behrens, RN, BSN 410-502-1914 kbehren1@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Glenn Whitman, MD

Johns Hopkins University

More Information

Publications:

Montejo JC, Miñambres E, Bordejé L, Mesejo A, Acosta J, Heras A, Ferré M, Fernandez-Ortega F, Vaquerizo CI, Manzanedo R. Gastric residual volume during enteral nutrition in ICU patients: the REGANE study. Intensive Care Med. 2010 Aug;36(8):1386-93. Epub 2010 Mar 16.

Hsu CW, Sun SF, Lin SL, Kang SP, Chu KA, Lin CH, Huang HH. Duodenal versus gastric feeding in medical intensive care unit patients: a prospective, randomized, clinical study. Crit Care Med. 2009 Jun;37(6):1866-72.

Acosta-Escribano J, Fernández-Vivas M, Grau Carmona T, Caturla-Such J, Garcia-Martinez M, Menendez-Mainer A, Solera-Suarez M, Sanchez-Payá J. Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial. Intensive Care Med. 2010 Sep;36(9):1532-9. Epub 2010 May 22.

Heyland DK, Drover JW, MacDonald S, Novak F, Lam M. Effect of postpyloric feeding on gastroesophageal regurgitation and pulmonary microaspiration: results of a randomized controlled trial. Crit Care Med. 2001 Aug;29(8):1495-501.

Davies AR, Froomes PR, French CJ, Bellomo R, Gutteridge GA, Nyulasi I, Walker R, Sewell RB. Randomized comparison of nasojejunal and nasogastric feeding in critically ill patients. Crit Care Med. 2002 Mar;30(3):586-90.

Responsible Party:	Dr. Glenn Whitmann, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01343316 History of Changes
Other Study ID Numbers:	NA_00041559
Study First Received:	April 26, 2011
Last Updated:	April 27, 2011
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 June 17, 2013

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