Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

NCT05146908 | Completed

• 1 other identifier: NGUYEN 2021-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Biomarkers of digestive distress have also been described in intensive care and can be measured directly in the plasma (lipopolysaccharide, intestinal fatty acid binding protein, citrulline, glucagon-like peptide-1). Enteral nutrition is a frequent therapy in intensive care patients, and its administration is recommended. In general, nurtition is resumed early via a nasogastric tube in patients placed on mechanical ventilation. The resumption of nutrition can be seen as a "challenge" to the gastrointestinal tract, and may thus unmask underlying gastrointestinal dysfunction. Intolerance of enteral nutrition is a symptom of gastrointestinal dysfunction and is associated with poor clinical outcomes. Indeed, it is both a marker of severity by reflecting organ dysfunction and responsible for a reduction in caloric intake that can influence prognosis. There is no consensus on the definition of intolerance to enteral nutrition. In practice, it is most often recognized because of regurgitation or vomiting, requiring reduction or discontinuation. In a recent review, the authors emphasize the need for digestive monitoring for early diagnosis of nutritional intolerance. Gastric echography is a minimally invasive and reliable means of monitoring the gastric contents. In particular, the surface of the antrum has been validated as a way to diagnose a full stomach in intensive care. The measurement of echographic variations in gastric residue with the resumption of enteral nutrition could thus allow the early diagnosis of gastrointestinal dysfunction and food intolerance by preceding vomiting. Our objective is to show the interest of echographic monitoring of the stomach during the resumption of enteral feeding for the diagnosis of nutritional intolerance. As nutritional intolerance is a symptom of gastrointestinal dysfunction, we will also study this phenomenon by measuring the associations between echographic data, clinical data and biomarkers of gastrointestinal dysfunction.

Conditions

Nutritional Intolerance

Outcome Measures

Primary Outcomes (1)

• Gastric antral surface in mm2

  Echographic measurement of the gastric antral area

  Up to 24 hours of enteral nutrition

Study Arms (1)

Patients in intensive care

Ventilated intubated patients for whom enteral nutrition is planned

Biological: 2 Blood samples from arterial and/or central venous catheters; Other: Echography; Other: Data collection

Interventions

2 Blood samples from arterial and/or central venous catheters BIOLOGICAL

5 mL blood sample taken at the same time as a blood sample scheduled in regular patient management before the introduction of enteral nutrition and 24H after

Patients in intensive care

Echography OTHER

In 3 steps: * before initiation of enteral nutrition * 4h after initiation of enteral nutrition * After 24 hours of enteral nutrition

Patients in intensive care

Data collection OTHER

At inclusion: Calculation of severity scores; collection of reason for admission and demographic data; main comorbidities and treatments administered; the time between admission and nutritional recovery; risk factors for gastroparesis; current organ failure and supplements. Presence of parenteral nutrition, ongoing carbohydrate intake. Caloric objective. Within the first 24 hours, collection of: * echographic parameters at H0, H4 and H24 * venous congestion parameters * biological parameters within 24 hours Constitution of a biobank (at H0 and H24) Within the first 7 days, collection of: * the occurrence or not of the primary endpoint (and time to occurrence). * symptoms of gastrointestinal dysfunction Within 30 days, collection of: * organ failure and replacement over the period, and mortality. * the occurrence or not of ventilator-associated lung disease (VAPD). Each patient is followed for 30 days. Survival will be assessed at 30 days before discharge from the study.

Patients in intensive care

Eligibility Criteria

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

Study Population

Patients admitted to the ICU for whom enteral nutrition is planned

You may qualify if:

• Patient admitted to intensive care
• Predicted duration of MV \> 48 hours
• Predicted start of enteral nutrition
• Time to the initiation of enteral nutrition and orotracheal intubation \< 36 hours

You may not qualify if:

• Person subject to a measure of legal protection (curatorship, guardianship)
• Pregnant, parturient or breastfeeding women
• Minors
• Non echogenic patient or without an exploitable echographic window
• History of gastric or esophageal surgery
• Limitations of care

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: a prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2025 Nov 12:101683. doi: 10.1016/j.accpm.2025.101683. Online ahead of print.

  PMID: 41238178 DERIVED

MeSH Terms

Interventions

High-Energy Shock Waves; Data Collection

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: November 29, 2021
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

FR (1)