Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01343316
• Other study ID #: NA_00041559
• Status: Terminated
• Phase: N/A
• First received: April 26, 2011
• Last updated: September 17, 2013
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)
To determine the benefits of utilizing one type of transpyloric tube over another.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. doi: 10.1007/s00134-010-1908-3. Epub 2010 May 22. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1097/CCM.0b013e31819ffcda. — View Citation

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. doi: 10.1007/s00134-010-1856-y. Epub 2010 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether transpyloric feeds are superior to transgastric feeds with regard to ability to give calories and meet nutritional goals.	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	No
Secondary	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.	Benefits include shorter time to appropriate placement and quicker time to goal tube feed rate.	one year	No