Ultrasound Meal Accommodation Test for Enteral Feeding in the Critically Ill

NCT03851354 | Completed

• 1 other identifier: DI1711203047
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Within the context of intensive care units (ICU), enteral nutrition (NE) is an essential tool in the management of critical patients. Gastrointestinal dysfunction causes significant difficulties in implementing enteral nutrition, and constitutes one of the main medical or non-avoidable causes to avoid enteral feeding in critically ill patients. Gastric ultrasound is a validated tool to non-invasively evaluate gastric volume and content. The purpose of this study is to evaluate the use of this test in critically ill patients for initiation and tolerance of the enteral feeding.

Conditions

Enteral Feeding Intolerance

Keywords

enteral feeding; gastric ultrasound

Outcome Measures

Primary Outcomes (1)

• GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE

  measure the diameter of the gastric cross sectional area change in time to evaluate enteral feeding tolerance

  1 hour

Study Arms (1)

Ultrasound meal accomodation test

OTHER

ultrasound guided gastric dynamics test for tolerance of enteral feeding, 500 ml of water with protein (glutamine or casseinate) wil be administrated

Other: Ultrasound meal acommodation test

Interventions

Ultrasound meal acommodation test OTHER

to observe their tolerance a 500 ml of solution with glutamine, or Caseinate and the protocol will be carried out will be given. Ultrasound measures will be performed and observing changes in Cross Sectional Area of the gastric antrum of the first measurement at the time after administration. Gastric residue will be measured.

Ultrasound meal accomodation test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gastrointestinal dysfunction who enter the intensive care unit grade I to III
• That they agree to participate in the study and sign informed consent
• Haven´t eat for more than 36 hours

You may not qualify if:

• Patients with grade IV gastrointestinal dysfunction
• Patient with absolute contraindication for the start of the enteral diet

Sponsors & Collaborators

• Grupo Mexicano para el Estudio de la Medicina Intensiva: lead

Study Sites (1)

Hospital de Especialidades Del Niño Y La Mujer

Querétaro City, Querétaro, 76090, Mexico

Location

Related Publications (6)

• Martindale RG, McClave SA, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; American College of Critical Care Medicine; A.S.P.E.N. Board of Directors. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition: Executive Summary. Crit Care Med. 2009 May;37(5):1757-61. doi: 10.1097/CCM.0b013e3181a40116. No abstract available.

  PMID: 19373044 BACKGROUND

• Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine); Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11.

  PMID: 16697087 BACKGROUND

• Mentec H, Dupont H, Bocchetti M, Cani P, Ponche F, Bleichner G. Upper digestive intolerance during enteral nutrition in critically ill patients: frequency, risk factors, and complications. Crit Care Med. 2001 Oct;29(10):1955-61. doi: 10.1097/00003246-200110000-00018.

  PMID: 11588461 BACKGROUND

• Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.

  PMID: 23302981 BACKGROUND

• Steinsvik EK, Hausken T, Gilja OH. The ultrasound meal accommodation test in 509 patients with functional gastrointestinal disorders. Scand J Gastroenterol. 2016 Jul;51(7):788-94. doi: 10.3109/00365521.2016.1153138. Epub 2016 Mar 8.

  PMID: 26953788 BACKGROUND

• Perez-Calatayud AA, Carrillo-Esper R, Carrillo-Torres O, Fareli-Gonzalez C, Pena-Perez C, Meza-Marquez JM, Mejia-Gomez LJ, Boy-Skipse M, Vazquez de Anda GF. Ultrasound meal accommodation test in critically ill patients with and without feeding intolerance UMAT-ICU. Clin Nutr ESPEN. 2022 Oct;51:424-429. doi: 10.1016/j.clnesp.2022.07.006. Epub 2022 Jul 20.

  PMID: 36184238 DERIVED

Study Officials

• Angel Augusto Perez-Calatayud, MD

  Head ICU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The measurement will be carried out by experienced intensive care physicians who have completed a 4-hour training (12 patients). Patients will be placed with elevation of the head at 30 ° (except in patients with hip or spinal cord injury). For gastric scanning, a 2 to 5 Hz curved transducer for ultrasound will be used, in a parasagittal plane in the epigastric area. The right lobe of the liver and the abdominal aorta will be used as posterior and internal reference points. Once the visualization is achieved, it will rotate to achieve the transverse view of the gastric antrum. Measurements will be made at 2, 5, 10, 20, 30 and 60 minutes for gastric tolerance and the difference between the initial and final measurement will be measured to see the tolerance of it. At the end of the test, a gastric residue measurement will be performed to compare results.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 22, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available as soon as the stadistical analisis is finished
• Access Criteria: open

Locations

ME (1)