Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

September 17, 2013 updated by: Glenn Whitman, Johns Hopkins University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients in the ICU setting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Glenn Whitman, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00041559

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Illness

Clinical Trials on Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe