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Ultrasound Meal Accommodation Test for Enteral Feeding in the Critically Ill (UMATI)

Primary Purpose

Enteral Feeding Intolerance

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Ultrasound meal acommodation test
Sponsored by
Grupo Mexicano para el Estudio de la Medicina Intensiva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Enteral Feeding Intolerance focused on measuring enteral feeding, gastric ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with grade IV gastrointestinal dysfunction
  2. Patient with absolute contraindication for the start of the enteral diet

Sites / Locations

  • Hospital de Especialidades Del Niño Y La Mujer

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultrasound meal accomodation test

Arm Description

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

Outcomes

Primary Outcome Measures

GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE
measure the diameter of the gastric cross sectional area change in time to evaluate enteral feeding tolerance

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
January 23, 2020
Sponsor
Grupo Mexicano para el Estudio de la Medicina Intensiva
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1. Study Identification

Unique Protocol Identification Number
NCT03851354
Brief Title
Ultrasound Meal Accommodation Test for Enteral Feeding in the Critically Ill
Acronym
UMATI
Official Title
Ultrasound Meal Accommodation Test to Predict Enteral Feeding Tolerance of Enteral Feeding in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Mexicano para el Estudio de la Medicina Intensiva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Within the context of intensive care units (ICU), enteral nutrition is an essential tool in the management of critical patients, because it preserves the structure and function of the gastrointestinal mucosa, decreases the catabolic response to injury when it is administered early, and could also reduce the incidence of bacterial translocation. These factors could play an important role in reducing infectious complications, compared with parenteral nutrition. Current clinical practice guidelines, have agreed on the need to implement early enteral nutrition in the critically ill patient. Moreover, today it is considered one of the quality standards in the intensive care units. However, it is often not feasible to initiate early enteral nutrition , due to the high incidence of gastrointestinal complications that act as a limiting factor. Within the gastrointestinal complications seen in the critically ill patient, gastroparesis is usually the most frequent caused in general by the delay of gastric emptying in the absence of mechanical obstruction, and is manifested by a high volume of gastric residue. It is a frequent problem and difficult to manage in ICUs, with a reported incidence of up to 50-60% in critical patients in mechanical ventilation (MV). Gastroparesis causes significant difficulties in implementing enteral nutrition, and constitutes one of the main medical or non-avoidable causes of its suspension; it can also cause hydroelectrolytic and acid-base disorders if the volume of gastric residue is of great magnitude. In addition, gastroparesis may favor gastroesophageal reflux and bacterial overgrowth, with increased risk of pulmonary aspiration, pneumonia and sepsis. Several factors have been implicated in the deterioration of gastrointestinal motility in critical patients. The most important are mechanical ventilation, the use of opioids, catecholamines (mainly dopamine), the presence of brain injury, sepsis, hyperglycemia, supine position, among others. However, there are aspects not yet defined with respect to their diagnostic criteria and their management. Gastric ultrasound is a validated tool to non-invasively evaluate gastric volume and content and predict the risk of pulmonary aspiration. It has a high sensitivity and specificity that makes it a gold standard. Its implementation in the preoperative evaluation of emergency surgery has proven to be a cost-effective test, that allows reducing the morbidity and mortality of patients, establishing preventive measures and intubation techniques that limit or eliminate the risk of pulmonary aspiration, reducing the days of stay Hospital and mortality. Based on the knowledge generated by gastric ultrasonography, the concept of "risk stomach" was coined. Bouvet defines "stomach of risk" when the gastric volume exceeds 0.8 mL / kg of weight, measured by transverse ultrasound at the level of the gastric antrum. This model can predict volumes from 0 to 500 mL and is applicable to adult patients with a body mass index of less than 40 kg / m2. The sensitivity and specificity of this model is 100%, which makes it the "gold standard" for non-invasive assessment of the stomach risk of lung gastric aspiration. The margin of error of the measurement is ± 6 mL. In patients with dyspepsia, the Gastric Accommodation Test guided by ultrasound has given good results as a diagnostic method for gastrointestinal disorders. In critically ill patients the clinical assessment of gastrointestinal function is not recognized, which leads to poor evolution with an increase in mobility and mortality. The current recommendations in critical patient nutrition are the initiation of enteral diet when it is possible, however, we do not have a monitoring method or biomarkers of gastrointestinal dysfunction, so intolerance can lead to life-threatening complications, and even more so now that the gastric residue has been identified as a risk factor for malnutrition (by removing the caloric content before absorption) and is also considered a risk factor for pneumonia associated with mechanical ventilation. The advantage of using ultrasound at the patient's bedside is that it reduces the risk of Broncho-aspiration and malnutrition with a non-invasive, radiation-free and cheap method. The purpose of this study is to evaluate the use of this test in critically ill patients for initiation and tolerance of enteral diet. Objectives. 1. To evaluate the ULTRASOUND GUIDED GASTRIC DYNAMICS TEST FOR TOLERANCE OF ENTERAL DIET IN CRITICAL PATIENTS Hypothesis The ULTRASOUND GUIDED GASTRY DYNAMICS TEST FOR ENTERAL DIET TOLERANCE IN CRITICAL PATIENTS (UMATI PROTOCOL) is useful for evaluating the initiation of enteral diet in critically ill patients with gastrointestinal dysfunction. Standardization of the ultrasound test All patients admitted to intensive therapy who present risk for gastrointestinal dysfunction grade I to III (tolerance to enteral diet should be assessed but not contraindicated) to observe their tolerance will be passed 500 ml of solution with glutamine, OR Caseinate and the protocol will be carried out. (Table 2) performing ultrasonographic measurements 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. All risk factors for known gastrointestinal dysfunction and relevant data of the clinical history, age, gender, BMI, time of initiation of enteral nutrition will be recorded. The latter will be evaluated individually for each patient according to known risk factors (mainly absolute contraindications for the onset of enteral nutrition in critical patients. The gastric volume by ultrasound will be calculated according to the model of Pearls GV (ml) = 27.0 + 14.6 × right-lateral cross sectional area (cm2) -1.28 × age (yr)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding Intolerance
Keywords
enteral feeding, gastric ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound meal accomodation test
Arm Type
Other
Arm Description
ultrasound guided gastric dynamics test for tolerance of enteral feeding, 500 ml of water with protein (glutamine or casseinate) wil be administrated
Intervention Type
Other
Intervention Name(s)
Ultrasound meal acommodation test
Intervention Description
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.
Primary Outcome Measure Information:
Title
GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE
Description
measure the diameter of the gastric cross sectional area change in time to evaluate enteral feeding tolerance
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with grade IV gastrointestinal dysfunction Patient with absolute contraindication for the start of the enteral diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Augusto Perez-Calatayud, MD
Organizational Affiliation
Head ICU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Especialidades Del Niño Y La Mujer
City
Querétaro City
State/Province
Queretaro
ZIP/Postal Code
76090
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
no plan has been develop
IPD Sharing Time Frame
data will be available as soon as the stadistical analisis is finished
IPD Sharing Access Criteria
open
Citations:
PubMed Identifier
19373044
Citation
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.
Results Reference
background
PubMed Identifier
16697087
Citation
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.
Results Reference
background
PubMed Identifier
11588461
Citation
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.
Results Reference
background
PubMed Identifier
23302981
Citation
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.
Results Reference
background
PubMed Identifier
26953788
Citation
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.
Results Reference
background
PubMed Identifier
36184238
Citation
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.
Results Reference
derived

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Ultrasound Meal Accommodation Test for Enteral Feeding in the Critically Ill

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