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临床试验/NCT04119089
NCT04119089已完成不适用

Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年5月30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
65
试验地点
1
主要终点
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.

研究概览

简要总结

It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.

Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).

Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.

Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.

This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.

Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.

This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
37 Weeks 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration > 48 hours.
  • Enteral nutrition that has been started for more than 48 hours and less than 7 days.
  • Age between 37 weeks of post conceptual age and 18 years.
  • Parental consent or consent by the person having parental authority.

排除标准

  • Abdominal surgery ≤ 1 year
  • History of esophageal, gastric, duodenal, or pancreatic surgery
  • Enteral nutrition via jejunostomy or gastrostomy.
  • Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)

结局指标

主要结局

Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.

时间窗: Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)

Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.

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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