Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

NCT01343316 | Terminated

• 1 other identifier: NA_00041559
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Enteral Feeds; Supplemental Feeds; Transpyloric Tube; Nasogastric Tube

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

Transgastric tube

Nasogastric (NG tube)

Device: Transpyloric feeding tubes (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)

Transpyloric tube - Syncro BlueTube

Magnetically placed

Device: Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)

Interventions

Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube) DEVICE

To determine the benefits of utilizing one type of transpyloric tube over another.

Also known as: Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube

Transgastric tube; Transpyloric tube - Syncro BlueTube; Transpyloric tube - Tiger2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients in the ICU setting

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (5)

• 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.

  PMID: 20232036 BACKGROUND

• 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.

  PMID: 19384225 BACKGROUND

• 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.

  PMID: 20495781 BACKGROUND

• 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.

  PMID: 11505114 BACKGROUND

• 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.

  PMID: 11990920 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Glenn Whitman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of CVSICU and Adult Heart Transplant

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 28, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

US (1)