Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

Terminated

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

• Registration Number: NCT01343316
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgastric tube	Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)	Nasogastric (NG tube)
Transpyloric tube - Tiger2	Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)	Self-propelled by paristaltic waves of the stomach
Transpyloric tube - Syncro BlueTube	Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)	Magnetically placed

Primary Outcome Measures

Name	Time	Method
To determine whether transpyloric feeds are superior to transgastric feeds with regard to ability to give calories and meet nutritional goals.	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

Name	Time	Method
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.	one year	Benefits include shorter time to appropriate placement and quicker time to goal tube feed rate.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States