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临床试验/NCT05146908
NCT05146908已完成不适用

Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Gastric antral surface in mm2

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Next-of-kin/health care proxy has not objected to the inclusion of the patient
  • 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

排除标准

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

结局指标

主要结局

Gastric antral surface in mm2

时间窗: Up to 24 hours of enteral nutrition

Echographic measurement of the gastric antral area

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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