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

January 23, 2020 updated by: Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva

Ultrasound Meal Accommodation Test to Predict Enteral Feeding Tolerance of Enteral Feeding in Critically Ill Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Queretaro
      • Querétaro City, Queretaro, Mexico, 76090
        • Hospital de Especialidades Del Niño Y La Mujer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasound meal accomodation test
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE
Time Frame: 1 hour
measure the diameter of the gastric cross sectional area change in time to evaluate enteral feeding tolerance
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Mexicano para el Estudio de la Medicina Intensiva

Investigators

  • Principal Investigator: Angel Augusto Perez-Calatayud, MD, Head ICU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI1711203047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enteral Feeding Intolerance

Clinical Trials on Ultrasound meal acommodation test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe