Enteral Feeding IntoleranceUMATINCT03851354
Ultrasound Meal Accommodation Test for Enteral Feeding in the Critically Ill
A study testing Ultrasound meal acommodation test in people with Enteral Feeding Intolerance, run by Grupo Mexicano para el Estudio de la Medicina Intensiva at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Ultrasound meal acommodation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with grade IV gastrointestinal dysfunction
- Patient with absolute contraindication for the start of the enteral diet
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Especialidades Del Niño Y La Mujer
Querétaro City, Querétaro, 76090
About this study
Official title: 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.
Read the 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.
- 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)
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Ultrasound meal acommodation test
- Keywords
- enteral feeding, gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound meal acommodation testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ultrasound meal acommodation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE
measure the diameter of the gastric cross sectional area change in time to evaluate enteral feeding tolerance
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Apr 2019
- Primary completion1 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Mexicano para el Estudio de la Medicina Intensiva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva
- Investigators
- Angel Augusto Perez-Calatayud, MD, Principal investigator, Head ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851354
- Sponsor's protocol ID
- DI1711203047
- Acronym
- UMATI
- Status last verified
- Jan 2020
- First submitted
- 19 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: no plan has been develop
Publications
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.
PubMed 19373044Kreymann 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.
PubMed 16697087Mentec 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.
PubMed 11588461Perlas 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.
PubMed 23302981Steinsvik 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.
PubMed 26953788Perez-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.
PubMed 36184238
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Meal Accommodation Test to Predict Enteral Feeding Tolerance of Enteral Feeding in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03851354
- Acronym / sponsor ID
- UMATI / DI1711203047
- Conditions
- Enteral Feeding Intolerance
- Keywords
- enteral feeding, gastric ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Grupo Mexicano para el Estudio de la Medicina IntensivaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound meal accomodation test | Other | Other: Ultrasound meal acommodation testultrasound guided gastric dynamics test for tolerance of enteral feeding, 500 ml of water with protein (glutamine or casseinate) wil be administrated |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with grade IV gastrointestinal dysfunction
- Patient with absolute contraindication for the start of the enteral diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound meal acommodation testto 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. | Other | Ultrasound meal accomodation test |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 19373044Martindale 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.
- Background: PubMed 16697087Kreymann 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.
- Background: PubMed 11588461Mentec 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.
- Background: PubMed 23302981Perlas 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.
- Background: PubMed 26953788Steinsvik 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.
- Derived from this study: PubMed 36184238Perez-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.
- Individual participant dataSharing planned: Yes. no plan has been develop
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Augusto Perez-Calatayud, MD principal investigator
Head ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound meal acommodation test in people with Enteral Feeding Intolerance, run by Grupo Mexicano para el Estudio de la Medicina Intensiva at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GASTRIC CROSS SECTIONAL AREA DIAMETER CHANGE (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851354, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.