Clinical trial NCT01343316: Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients
Official title: Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critical Illness
Keywords: Enteral Feeds
Supplemental Feeds
Transpyloric Tube
Nasogastric Tube
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients in the ICU setting

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.


Eligibility 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

Primary outcomes:
measure: To determine whether transpyloric feeds are superior to transgastric feeds with regard to ability to give calories and meet nutritional goals.
timeFrame: one year
Secondary outcomes:
measure: 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.
timeFrame: one year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Glenn Whitman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montejo JC, Minambres E, Bordeje L, Mesejo A, Acosta J, Heras A, Ferre 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.
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.
citation: Acosta-Escribano J, Fernandez-Vivas M, Grau Carmona T, Caturla-Such J, Garcia-Martinez M, Menendez-Mainer A, Solera-Suarez M, Sanchez-Paya 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.
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. doi: 10.1097/00003246-200108000-00001.
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. doi: 10.1097/00003246-200203000-00016.